Obsessive-Compulsive DisorderNCT03343106
Combining Acceptance and Commitment Therapy With Exposure and Response Prevention to Enhance Treatment Engagement
A study testing ACT plus ERP and ERP alone in people with Obsessive-Compulsive Disorder, run by Utah State University at 2 sites in United States.
Trial summary
The aim of the study was to evaluate whether integrating Acceptance and Commitment Therapy (ACT) with Exposure and Response Prevention (ERP) increases the acceptability, tolerability, and adherence with ERP techniques relative to ERP without ACT. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- ACT plus ERP and ERP alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jul 2011to 9 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current DSM-IV-TR principal diagnosis of OCD for at least 1 year
- Willing to attend all 16 therapy sessions
- Fluent in English
- No previous Cognitive Behavior Therapy or Acceptance and Commitment Therapy for OCD
- If on medication for OCD, willing to remain at a fixed dose while participating in the study
Who cannot join
- Current severe depression or suicidal ideation
- Current substance abuse or dependence
- Current mania, psychosis, or borderline or schizotypal personality disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Utah State University
Logan, Utah, 84322
About this study
Official title: Combining Acceptance and Commitment Therapy With Exposure and Response Prevention to Enhance Treatment Engagement in Obsessive-Compulsive Disorder
The aim of the study was to evaluate whether integrating Acceptance and Commitment Therapy (ACT) with Exposure and Response Prevention (ERP) increases the acceptability, tolerability, and adherence with ERP techniques relative to ERP without ACT. Fifty-eight adults with a DSM-IV diagnosis of Obsessive-Compulsive Disorder (OCD) received 16 twice-weekly sessions (2 hours per session) of either ERP with the inclusion of ACT techniques (ERP+ACT; n = 30) or ERP alone (n = 28). Assessments using interviews, self-report questionnaires, and behavioral observations were conducted at pre- and post-test, and at 6 month follow-up. Specific hypotheses were: 1) Patients receiving ERP+ACT will report greater treatment acceptability, and show higher quantity and quality of completed self-directed ERP assignments, relative to patients receiving standard ERP; 2) Both ERP and ERP+ACT will lead to clinically significant reductions in OCD symptoms from pre- to post-test and from pre-test to follow-up.
Read the detailed description
- BACKGROUND AND SIGNIFICANCE. The most effective psychological treatment for Obsessive-Compulsive Disorder (OCD) is Exposure and Response Prevention (ERP), which entails confronting obsessional triggers (i.e., exposure) and resisting urges to ritualize (response prevention). Although successful, these techniques are challenging and provoke high levels of anxiety. This may contribute to the fact that between 25% and 50% of patients with access to ERP refuse treatment, drop out prematurely, or do not adhere to the treatment instructions and show attenuated response. Given the effectiveness of ERP techniques, developing ways to make them more tolerable and increase patient adherence, while not compromising therapeutic integrity, is an important next step in OCD treatment research. Recent investigations have addressed whether adding medications, cognitive therapy, or motivational Interviewing to ERP improves outcome and adherence; yet to date, no consensus has emerged regarding the degree to which these combination treatments are more effective than ERP monotherapy. Acceptance and Commitment Therapy (ACT), which has recently been studied for OCD, offers new hope for addressing the tolerability and adherence issues with ERP. Specifically, ACT uses acceptance and mindfulness processes to foster a willingness to experience unwanted inner experiences (e.g., obsessional thoughts, anxiety). These acceptance and mindfulness processes are consistent with ERP, but they are hypothesized to increase engagement in exposure exercises beyond ERP alone. There is evidence for this claim from a randomized trial which demonstrated that ACT, without in-session exposure, had clinical response rates in the 55-65% range at posttreatment and three month follow-up using an intent to treat analysis. Additionally, drop-out and refusal rates were low at 12.2% and treatment acceptability at posttreatment was near the maximum on the scale 4.3 out of 5. In this study, for experimental reasons, ACT did not include in-session ERP. However, the most theoretically and practically consistent use of ACT for OCD is as a context from which to conduct exposure therapy or ERP. While ACT focuses on processes (e.g., acceptance, defusion, values) that are distinct from those involved in ERP (e.g., habituation, cognitive change), an important goal of both treatments is to broaden the patient's engagement with feared stimuli. In fact, ACT procedures have been shown to increase involvement in difficult activities, including participating in exposure therapy for anxiety disorders and willingness to experience unwanted obsessive thoughts. Thus, building ACT techniques into ERP is likely to help patients (a) engage in ERP tasks, (b) confront high levels of anxiety without using escape/avoidance strategies, and (c) resist rituals. The aim of the proposed study is to evaluate whether integrating ACT increases the acceptability, tolerability, and adherence with ERP techniques relative to ERP without ACT.
- STUDY DESIGN AND HYPOTHESES. Fifty-eight adults with a DSM-IV diagnosis of Obsessive-Compulsive Disorder (OCD) received 16 twice-weekly sessions (2 hours per session) of either ERP with the inclusion of ACT techniques (ERP+ACT; n = 30) or ERP alone (n = 28). Assessments using interviews, self-report questionnaires, and behavioral observations were conducted at pre- and post-test, and at 6 month follow-up. Specific hypotheses were: 1) Patients receiving ERP+ACT will report greater treatment acceptability, and show higher quantity and quality of completed self-directed ERP assignments, relative to patients receiving standard ERP; 2) Both ERP and ERP+ACT will lead to clinically significant reductions in OCD symptoms from pre- to post-test and from pre-test to follow-up.
- METHODS
3a. Sample Size and Recruitment. The investigators aimed for an intent-to-treat sample of 60 adults across two sites: The Center for Clinical Research at Utah State University (USU) and the Anxiety and Stress Disorders Clinic at the University of North Carolina, Chapel Hill (UNC). Patients were recruited via advertisement of the study and via referrals from primary care and mental health providers familiar with the treatment centers. The USU Center (Twohig) and the UNC Clinic (Abramowitz) are well known research-oriented treatment clinics in their regions. USU is within a 1:30 minute drive of two million people and travel for treatment is common given the rural nature of the area. Also, no other known entity recruits participants with OCD in this area. The Raleigh-Durham-Chapel Hill area of NC is home to over one million people, and the UNC Clinic receives a steady stream of inquiries for treatment. Patient advocacy groups and associations that post research trials on the Internet were contacted to further publicize the study.
3b. Establishing Diagnoses. All diagnoses were established by trained interviewers using the Mini International Neuropsychiatric Interview (MINI).
3c. Randomization to Treatment Groups. Subsequent to screening, 30 individuals were randomly assigned (using a random number generator) to receive ERP+ACT and 28 to receive ERP monotherapy. With the exception of the inclusion of ACT techniques in the ERP+ACT condition, treatment was identical across the two groups (i.e., the number and duration of exposure sessions were the same).
3d. Treatments. ERP. ERP treatment was manualized based on Kozak and Foa's protocol and included 16 twice-weekly 120 minute sessions. Therapists were advanced graduate students who had received extensive training from experts in ERP and ACT for OCD. Sessions 1 and 2 included information-gathering, psychoeducation, presentation of the rationale for ERP, and introduction to self-monitoring of rituals. Session 3 was dedicated to developing the treatment plan (exposure hierarchy, response prevention plan). Sessions 4-15 included in-session prolonged and repeated gradual exposure therapy, informal discussion of mistaken cognitions, daily exposure homework assignments, and instructions to refrain from rituals (response prevention in session and between sessions), along with self monitoring of any rituals that were performed. Session 16 addressed discontinuation and relapse prevention.
ACT+ERP. This condition matched the ERP condition in terms of the number and duration of exposure sessions. Sessions 1 and 2 involved an abbreviated discussion of the ACT model of ERP focusing on acceptance of obsessions and anxiety, just noticing and not acting on obsessions, being present with one's internal experiences, and linking therapy to one's values. Session 3 involved the development of an exposure hierarchy and response prevention plan, and explaining the ACT-based approach to ERP which focuses on learning flexible responding in the presence of obsessions, anxiety, and urges to ritualize. The exposure exercises were procedurally similar to ERP but focused on the facilitation of ACT processes. For example, the therapist might teach just noticing of obsessions by exposing the participant to the feared stimulus and asking the participant to watch the obsessional thoughts pass by as if they were leaves floating on a stream. Homework exposure practice was linked to the patient's goals and values, and participants were instructed to practice ACT processes during these assignments. Session 16 covered an ACT-based model of relapse prevention focusing on following one's values in the presence of obsessive thoughts and compulsive urges.
3e. Standardization and Integrity Procedures. All assessors and therapists were trained to competency in their duties by Drs. Twohig and Abramowitz. All assessment and treatment sessions were videotaped and a random selection of 20% of tapes were reviewed by the investigators and scored for integrity of implementation. Drs. Twohig and Abramowitz also served as supervisors on the project. Cross-site data and video sharing of supervision occurred via the Internet in a HIPAA-compliant manner and weekly meetings occurred via Skype.
3f. Length of Study. The length of the study was 6 years. The investigators developed the ERP+ACT treatment manual during the first two months of the study period. Following this, the investigators completed recruitment and treatment of all patients between the 1st and 6th years. This left the final 1 year for follow-up data collection, data analysis, and for writing up and presenting the results.
3g. Statistical Methods. The investigators will use the following procedures to address each hypotheses: 1) Between-groups t-tests to examine differences on measures of treatment acceptability and the quantity and quality of adherence to ERP assignments at post-treatment. Corresponding effect sizes will be computed to examine the magnitude of this effect. 2) Within-group t-tests to determine the statistical significance of pre-posttest and pretest-follow-up differences on outcome measures. Corresponding within-group effect sizes will also be computed to examine the magnitude of these differences. Further, the methods described by Jacobson \& Truax to examine the extent of clinically significant and reliable change from pre to posttest and at follow-up will be utilized.
3h. Power Analyses. Power calculations were based on the average within-group effect size of 1.41 reported in a meta-analysis of CBT for OCD. This effect size was derived from clinical interview measures (e.g., the Yale-Brown Obsessive Compulsive Scale). A sample size of 60 affords greater than 90% power to detect a similar effect size with a t-test in the present study if alpha is set at .05. There are no available studies comparing treatment adherence and quality of life between two active psychological treatments for OCD from which to calculate power estimates. The investigators will therefore examine effect sizes in addition to significance levels when comparing between ERP+ACT and ERP on these variables.
- INTENDED USE OF THE RESULTS
The results from the present study will be published and disseminated through conference presentations. They will also be used as pilot data to apply for NIMH funding for a larger study using the R34 mechanism (treatment development).
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- ACT plus ERP, ERP alone
- Keywords
- Acceptance and Commitment Therapy, Exposure and Response Prevention, Psychotherapy, Obsessive-Compulsive Disorder, Treatment Acceptability, Treatment Adherence
- Medical subject headings
- Obsessive-Compulsive Disorder, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT plus ERPBehavioural
16 twice-weekly sessions of 120-minute individual psychotherapy consisting of Acceptance and Commitment Therapy plus Exposure and Response Prevention (ACT plus ERP).
ERP aloneBehavioural
16 twice-weekly sessions of 120-minute individual psychotherapy consisting of Exposure and Response Prevention (ERP alone) monotherapy.
| Study group | Role | What they receive |
|---|---|---|
| ACT plus ERP | Experimental | Sessions 1 and 2 involved information-gathering, discussion of the ACT model of OCD and ERP, and introduction to self-monitoring of rituals. Session 3 involved the development of an exposure hierarchy and response prevention plan, and further explanation of the ACT-based approach to ERP which focuses on learning flexible responding in the presence of obsessions, anxiety, and urges to ritualize. Exposure practices (sessions 4-16) were procedurally similar to the ERP condition, but focused on the facilitation of ACT processes rather than on fear extinction. Homework exposure practice was linked to the participant's goals and values. Session 16 included an ACT model of relapse prevention focusing on following one's values in the presence of obsessive thoughts and compulsive urges. Receives: Behavioral: ACT plus ERP |
| ERP alone | Experimental | ERP followed Kozak and Foa's treatment manual. Sessions 1 and 2 included information-gathering, psychoeducation about the cognitive-behavioral model of OCD and rationale for ERP, and introduction to self-monitoring of rituals. Session 3 was dedicated to developing the treatment plan (exposure hierarchy, response prevention plan). Sessions 4-16 included in-session prolonged and repeated gradual exposure therapy (in vivo and imaginal as needed), the assignment of daily exposure practices for between-sessions, and instructions to refrain from rituals (response prevention in session and between sessions), along with self monitoring of any rituals that were performed. Session 16 also addressed discontinuation and relapse prevention. Receives: Behavioral: ERP alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 8 weeks
Global OCD severity was measured using the Y-BOCS, a semi-structured interview that includes a symptom checklist and 10-item severity scale. The checklist is first used to identify the patient's particular obsessions and compulsions. The severity scale then assesses the main obsessions (items 1-5) and compulsions (items 6-10) on the following five parameters: (a) time, (b) interference, (c) distress, (d) resistance, and (e) degree of control. The clinician rates each item from 0 (no symptoms) to 4 (extreme) based on the past week. The 10 items are added to produce a total severity score that ranges from 0 to 40. The Y-BOCS is the most widely used measure of OCD severity and has satisfactory psychometric properties. The internal consistency (Cronbach's alpha) of the pre-treatment Y-BOCS in the present sample was .74.
Measured: Posttreatment (8 weeks after Baseline)
Change from Posttreatment Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 6 months
Global OCD severity was measured using the Y-BOCS, a semi-structured interview that includes a symptom checklist and 10-item severity scale. The checklist is first used to identify the patient's particular obsessions and compulsions. The severity scale then assesses the main obsessions (items 1-5) and compulsions (items 6-10) on the following five parameters: (a) time, (b) interference, (c) distress, (d) resistance, and (e) degree of control. The clinician rates each item from 0 (no symptoms) to 4 (extreme) based on the past week. The 10 items are added to produce a total severity score that ranges from 0 to 40. The Y-BOCS is the most widely used measure of OCD severity and has satisfactory psychometric properties. The internal consistency (Cronbach's alpha) of the pre-treatment Y-BOCS in the present sample was .74.
Measured: Follow-up (6 months after the end of treatment)
Secondary outcomes (19)
Change from Baseline Beck Depression Inventory II (BDI-II) at 8 weeks
The BDI-II is a 21-item self-report scale that assesses the severity of affective, cognitive, motivational, vegetative, and psychomotor components of depression. Scores of 10 or less are considered normal; scores of 20 or greater suggest the presence of clinical depression. The BDI has excellent reliability and validity and is widely used in clinical research. In the present sample, the pre-treatment BDI had a Cronbach's alpha of .93.
Measured: Posttreatment (8 weeks after Baseline)
Change from Posttreatment Beck Depression Inventory II (BDI-II) at 6 months
The BDI is a 21-item self-report scale that assesses the severity of affective, cognitive, motivational, vegetative, and psychomotor components of depression. Scores of 10 or less are considered normal; scores of 20 or greater suggest the presence of clinical depression. The BDI has excellent reliability and validity and is widely used in clinical research. In the present sample, the pre-treatment BDI had a Cronbach's alpha of .93.
Measured: Follow-up (6 months after the end of treatment)
Change from Baseline Acceptance and Action Questionnaire - II (AAQ-II) at 8 weeks
The AAQ-II is a 7-item 7-point Likert-type measure of experiential avoidance/psychological inflexibility. The items reflect: (a) unwillingness to experience unwanted emotions and thoughts, and (b) the inability to be in the present moment and behave according to value-directed actions when experiencing unwanted psychological events. The AAQ-II shows good psychometric properties (mean alpha of .88). In present sample, the pre-treatment AAQ-II had a Cronbach's alpha of .87.
Measured: Posttreatment (8 weeks after Baseline)
Change from Posttreatment Acceptance and Action Questionnaire - II (AAQ-II) at 6 months
The AAQ-II is a 7-item 7-point Likert-type measure of experiential avoidance/psychological inflexibility. The items reflect: (a) unwillingness to experience unwanted emotions and thoughts, and (b) the inability to be in the present moment and behave according to value-directed actions when experiencing unwanted psychological events. The AAQ-II shows good psychometric properties (mean alpha of .88). In present sample, the pre-treatment AAQ-II had a Cronbach's alpha of .87.
Measured: Follow-up (6 months after the end of treatment)
Session-level Change in Acceptance and Action Questionnaire - II (AAQ-II) at each session
The AAQ-II is a 7-item 7-point Likert-type measure of experiential avoidance/psychological inflexibility. The items reflect: (a) unwillingness to experience unwanted emotions and thoughts, and (b) the inability to be in the present moment and behave according to value-directed actions when experiencing unwanted psychological events. The AAQ-II shows good psychometric properties (mean alpha of .88). In present sample, the pre-treatment AAQ-II had a Cronbach's alpha of .87.
Measured: Sessions 1-16 (Twice per week for 8 weeks following Baseline)
Change from Baseline Distress Tolerance Scale (DTS) at 8 weeks
The DTS is composed of 14 items answered on 5-point Likert-type scales ranging from 1, strongly agree, to 5, strongly disagree, evaluating participants' ability to experience and endure negative emotional states. Greater scores reflect higher levels of distress tolerance. This scale has good psychometric properties, including high internal consistency (α=.89) and appropriate convergence with other self-report ratings of affective distress and regulation. In addition, the DTS has demonstrated adequate 6-month test-retest reliability (r=.61). In the present sample, the pre-treatment DTS had a Cronbach's alpha of .94.
Measured: Posttreatment (8 weeks after Baseline)
Change from Posttreatment Distress Tolerance Scale (DTS) at 6 months
The DTS is composed of 14 items answered on 5-point Likert-type scales ranging from 1, strongly agree, to 5, strongly disagree, evaluating participants' ability to experience and endure negative emotional states. Greater scores reflect higher levels of distress tolerance. This scale has good psychometric properties, including high internal consistency (α=.89) and appropriate convergence with other self-report ratings of affective distress and regulation. In addition, the DTS has demonstrated adequate 6-month test-retest reliability (r=.61). In the present sample, the pre-treatment DTS had a Cronbach's alpha of .94.
Measured: Follow-up (6 months after the end of treatment)
Change from Baseline Interpretation of Intrusions Inventory (III) at 8 weeks
The III is a semi-idiographic measure designed to assess negative appraisals of intrusive thoughts. The respondent reads a set of instructions that includes examples of intrusive thoughts (e.g., images of the baby lying dead in his crib, an impulse to shake the infant very hard) and then is asked to identify one or two examples of his or her own intrusions. The respondent then identifies the extent of his or her agreement with 31 items concerning various negative appraisals of these intrusions (e.g., "I would be a better person if I didn't have this thought"). Although 3 theoretically derived subscales were initially proposed: (a) importance of thoughts, (b) control of thoughts, and (c) responsibility, data suggests that only a single factor exists. The internal consistency of the pre-treatment III in the present sample was .94.
Measured: Posttreatment (8 weeks after Baseline)
Change from Posttreatment Interpretation of Intrusions Inventory (III) at 6 months
The III is a semi-idiographic measure designed to assess negative appraisals of intrusive thoughts. The respondent reads a set of instructions that includes examples of intrusive thoughts (e.g., images of the baby lying dead in his crib, an impulse to shake the infant very hard) and then is asked to identify one or two examples of his or her own intrusions. The respondent then identifies the extent of his or her agreement with 31 items concerning various negative appraisals of these intrusions (e.g., "I would be a better person if I didn't have this thought"). Although 3 theoretically derived subscales were initially proposed: (a) importance of thoughts, (b) control of thoughts, and (c) responsibility, data suggests that only a single factor exists. The internal consistency of the pre-treatment III in the present sample was .94.
Measured: Follow-up (6 months after the end of treatment)
Session-level Change in Interpretation of Intrusions Inventory (III) at each session
The III is a semi-idiographic measure designed to assess negative appraisals of intrusive thoughts. The respondent reads a set of instructions that includes examples of intrusive thoughts (e.g., images of the baby lying dead in his crib, an impulse to shake the infant very hard) and then is asked to identify one or two examples of his or her own intrusions. The respondent then identifies the extent of his or her agreement with 31 items concerning various negative appraisals of these intrusions (e.g., "I would be a better person if I didn't have this thought"). Although 3 theoretically derived subscales were initially proposed: (a) importance of thoughts, (b) control of thoughts, and (c) responsibility, data suggests that only a single factor exists. The internal consistency of the pre-treatment III in the present sample was .94.
Measured: Sessions 1-16 (twice per week for 8 weeks following Baseline)
Change from Baseline Believability of Anxious Feelings and Thoughts Questionnaire (BAFT) at 8 weeks
The BAFT is a self-report measure of cognitive fusion with anxious thoughts and feelings. It consists of 16 items representing different thoughts which are rated on a 7-point Likert-type scale ranging from 1 (not at all believable) to 7 (completely believable) to the extent that the individual believes in them. A hierarchical factor structure of the BAFT with three lower order factors and one hierarchical factor was found. The three lower order factors were labeled Somatic Concerns (fusion with somatic concerns), Emotion Regulation (fusion with excessive struggle with and control of emotions), and Negative Evaluation (fusion with negative evaluation of anxious thoughts and feelings). The internal consistency of the total pre-treatment BAFT in the present sample was .86. Individual subscale internal consistencies ranged from .72 to .77.
Measured: Posttreatment (8 weeks after Baseline)
Change from Posttreatment Believability of Anxious Feelings and Thoughts Questionnaire (BAFT) at 6 months
The BAFT is a self-report measure of cognitive fusion with anxious thoughts and feelings. It consists of 16 items representing different thoughts which are rated on a 7-point Likert-type scale ranging from 1 (not at all believable) to 7 (completely believable) to the extent that the individual believes in them. A hierarchical factor structure of the BAFT with three lower order factors and one hierarchical factor was found. The three lower order factors were labeled Somatic Concerns (fusion with somatic concerns), Emotion Regulation (fusion with excessive struggle with and control of emotions), and Negative Evaluation (fusion with negative evaluation of anxious thoughts and feelings). The internal consistency of the total pre-treatment BAFT in the present sample was .86. Individual subscale internal consistencies ranged from .72 to .77.
Measured: Follow-up (6 months after the end of treatment)
Change from Baseline Obsessive Beliefs Questionnaire (OBQ) at 8 weeks
The OBQ is a 44-item self-report questionnaire developed to assess a variety of dysfunctional beliefs thought to underlie OCD symptoms. Three factor analytically derived subscales correspond to the following domains of obsessive beliefs: (a) overestimates of threat and responsibility for harm, (b) importance and control of intrusive thoughts, and (c) perfectionism and the need for certainty. Participants rate their agreement with each of 44 statements from 1 (disagree very much) to 7 (agree very much). The instrument possesses good validity and internal consistency, and has been widely studied in clinical and nonclinical samples. Cronbach alphas for the subscales ranged from .89 to .91.
Measured: Posttreatment (8 weeks after Baseline)
Change from Posttreatment Obsessive Beliefs Questionnaire (OBQ) at 6 months
The OBQ is a 44-item self-report questionnaire developed to assess a variety of dysfunctional beliefs thought to underlie OCD symptoms. Three factor analytically derived subscales correspond to the following domains of obsessive beliefs: (a) overestimates of threat and responsibility for harm, (b) importance and control of intrusive thoughts, and (c) perfectionism and the need for certainty. Participants rate their agreement with each of 44 statements from 1 (disagree very much) to 7 (agree very much). The instrument possesses good validity and internal consistency, and has been widely studied in clinical and nonclinical samples. Cronbach alphas for the subscales ranged from .89 to .91.
Measured: Follow-up (6 months after the end of treatment)
Session-level Change in Patient EX/RP Adherence Scale - Therapist Rated at each session beginning with session 4
The PEAS is a 3-item questionnaire that assesses patient adherence to between-session exposures and response prevention in exposure and response prevention (ERP) therapy. This form is rated by the therapist.
Measured: Sessions 4-16 (twice per week for 6 weeks following week 2 of treatment)
Treatment Credibility and Expectancy Questionnaire
The Treatment Credibility and Expectancy Questionnaire is a 6-item questionnaire that assesses patient beliefs about the credibility and useful of the treatment they received, on a 10-point scale.
Measured: Session 4 (2 weeks following Baseline)
Change from Baseline Dimensional Obsessive Compulsive Scale (DOCS) at 8 weeks
The DOCS is a 20-item self-report measure that assesses the severity of the four most consistently replicated OCD symptom dimensions, which correspond to the measure's four empirically derived subscales: (a) contamination, (b) responsibility for harm and mistakes, (c) symmetry/ordering, and (d) unacceptable thoughts. Five items (rated 0 to 4) assess the following parameters of severity of each dimension: (a) time occupied by obsessions and rituals, (b) avoidance, (c) distress, (d) functional interference, and (e) difficulty disregarding the obsessions and refraining from rituals. Scores on these subscales converge well with other measures of OCD symptom dimensions. The internal consistency of the pre-treatment DOCS subscales in the present sample ranged from ( = .93-.96; total scale = .84).
Measured: Posttreatment (8 weeks after Baseline)
Change from Posttreatment Dimensional Obsessive Compulsive Scale (DOCS) at 6 months
The DOCS is a 20-item self-report measure that assesses the severity of the four most consistently replicated OCD symptom dimensions, which correspond to the measure's four empirically derived subscales: (a) contamination, (b) responsibility for harm and mistakes, (c) symmetry/ordering, and (d) unacceptable thoughts. Five items (rated 0 to 4) assess the following parameters of severity of each dimension: (a) time occupied by obsessions and rituals, (b) avoidance, (c) distress, (d) functional interference, and (e) difficulty disregarding the obsessions and refraining from rituals. Scores on these subscales converge well with other measures of OCD symptom dimensions. The internal consistency of the pre-treatment DOCS subscales in the present sample ranged from ( = .93-.96; total scale = .84).
Measured: Follow-up (6 months after the end of treatment)
Session-level Change in Dimensional Obsessive Compulsive Scale at each session
The DOCS is a 20-item self-report measure that assesses the severity of the four most consistently replicated OCD symptom dimensions, which correspond to the measure's four empirically derived subscales: (a) contamination, (b) responsibility for harm and mistakes, (c) symmetry/ordering, and (d) unacceptable thoughts. Five items (rated 0 to 4) assess the following parameters of severity of each dimension: (a) time occupied by obsessions and rituals, (b) avoidance, (c) distress, (d) functional interference, and (e) difficulty disregarding the obsessions and refraining from rituals. Scores on these subscales converge well with other measures of OCD symptom dimensions. The internal consistency of the pre-treatment DOCS subscales in the present sample ranged from ( = .93-.96; total scale = .84).
Measured: Sessions 1-16 (twice per week for 8 weeks following Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start12 Jul 2011
- Primary completion9 Jan 2017
- Study completion9 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, International OCD Foundation
- Responsible party
- Principal investigator, Michael Twohig, Ph.D., Utah State University
- Investigators
- Michael P Twohig, Ph.D., Principal investigator, Utah State UniversityJonathan Abramowitz, Ph.D., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343106
- Sponsor's protocol ID
- 2965
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Abramowitz JS, Deacon BJ, Olatunji BO, Wheaton MG, Berman NC, Losardo D, Timpano KR, McGrath PB, Riemann BC, Adams T, Bjorgvinsson T, Storch EA, Hale LR. Assessment of obsessive-compulsive symptom dimensions: development and evaluation of the Dimensional Obsessive-Compulsive Scale. Psychol Assess. 2010 Mar;22(1):180-98. doi: 10.1037/a0018260.
PubMed 20230164Abramowitz JS, Foa EB, Franklin ME. Exposure and ritual prevention for obsessive-compulsive disorder: effects of intensive versus twice-weekly sessions. J Consult Clin Psychol. 2003 Apr;71(2):394-8. doi: 10.1037/0022-006x.71.2.394.
PubMed 12699033Abramowitz JS, Franklin ME, Zoellner LA, DiBernardo CL. Treatment compliance and outcome in obsessive-compulsive disorder. Behav Modif. 2002 Sep;26(4):447-63. doi: 10.1177/0145445502026004001.
PubMed 12205821Abramowitz JS, Taylor S, McKay D. Potentials and limitations of cognitive treatments for obsessive-compulsive disorder. Cogn Behav Ther. 2005;34(3):140-7. doi: 10.1080/16506070510041202.
PubMed 16195053Abramowitz JS, Taylor S, McKay D. Obsessive-compulsive disorder. Lancet. 2009 Aug 8;374(9688):491-9. doi: 10.1016/S0140-6736(09)60240-3.
PubMed 19665647Beck, A. T. (1996). Beck Depression Inventory (2nd ed.). San Antonio, TX: The Psychological Corporation.
Eifert, G. H., & Forsyth, J. P. (2005). Acceptance and commitment therapy for anxiety disorders: A practitioner's treatment guide to using mindfulness, acceptance, and values-based behavior change strategies. Oakland, CA US: New Harbinger Publications.
Foa EB, Kozak MJ, Goodman WK, Hollander E, Jenike MA, Rasmussen SA. DSM-IV field trial: obsessive-compulsive disorder. Am J Psychiatry. 1995 Jan;152(1):90-6. doi: 10.1176/ajp.152.1.90.
PubMed 7802127Foa EB, Liebowitz MR, Kozak MJ, Davies S, Campeas R, Franklin ME, Huppert JD, Kjernisted K, Rowan V, Schmidt AB, Simpson HB, Tu X. Randomized, placebo-controlled trial of exposure and ritual prevention, clomipramine, and their combination in the treatment of obsessive-compulsive disorder. Am J Psychiatry. 2005 Jan;162(1):151-61. doi: 10.1176/appi.ajp.162.1.151.
PubMed 15625214Franklin, M. E. (2005). Combining serotonin medication with cognitive-behavior therapy: Is it necessary for all OCD patients. In J. Abramowitz & A. Houts (eds.). Concepts and controversies in obsessive-compulsive disorder (pp. 377-389). New York: Springer.
Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007.
PubMed 2684084Hayes, S. C. (2008). Climbing our hills: A beginning conversation on the comparison of acceptance and commitment therapy and traditional cognitive behavioral therapy. Clinical Psychology: Science and Practice, 15, 286-295.
Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (1999). Acceptance and commitment therapy: An experiential approach to behavior change. New York, NY US: Guilford Press.
Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12.
PubMed 2002127Kelley, M. L., Heffer, R. W., Gresham, F. M., & Elliott, S. N. (1989). Development of a modified Treatment Evaluation Inventory. Journal of Psychopathology and Behavioral Assessment, 11, 235-247.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Acceptance and Commitment Therapy With Exposure and Response Prevention to Enhance Treatment Engagement in Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT03343106
- Acronym / sponsor ID
- 2965
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Acceptance and Commitment Therapy, Exposure and Response Prevention, Psychotherapy, Obsessive-Compulsive Disorder, Treatment Acceptability, Treatment Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, International OCD Foundation
- Study start
- 12 Jul 2011 (actual)
- Primary completion
- 9 Jan 2017 (actual)
- Study completion
- 9 Jan 2017 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to evaluate whether integrating Acceptance and Commitment Therapy (ACT) with Exposure and Response Prevention (ERP) increases the acceptability, tolerability, and adherence with ERP techniques relative to ERP without ACT. Fifty-eight adults with a DSM-IV diagnosis of Obsessive-Compulsive Disorder (OCD) received 16 twice-weekly sessions (2 hours per session) of either ERP with the inclusion of ACT techniques (ERP+ACT; n = 30) or ERP alone (n = 28). Assessments using interviews, self-report questionnaires, and behavioral observations were conducted at pre- and post-test, and at 6 month follow-up. Specific hypotheses were: 1) Patients receiving ERP+ACT will report greater treatment acceptability, and show higher quantity and quality of completed self-directed ERP assignments, relative to patients receiving standard ERP; 2) Both ERP and ERP+ACT will lead to clinically significant reductions in OCD symptoms from pre- to post-test and from pre-test to follow-up.
Detailed description
- BACKGROUND AND SIGNIFICANCE. The most effective psychological treatment for Obsessive-Compulsive Disorder (OCD) is Exposure and Response Prevention (ERP), which entails confronting obsessional triggers (i.e., exposure) and resisting urges to ritualize (response prevention). Although successful, these techniques are challenging and provoke high levels of anxiety. This may contribute to the fact that between 25% and 50% of patients with access to ERP refuse treatment, drop out prematurely, or do not adhere to the treatment instructions and show attenuated response. Given the effectiveness of ERP techniques, developing ways to make them more tolerable and increase patient adherence, while not compromising therapeutic integrity, is an important next step in OCD treatment research. Recent investigations have addressed whether adding medications, cognitive therapy, or motivational Interviewing to ERP improves outcome and adherence; yet to date, no consensus has emerged regarding the degree to which these combination treatments are more effective than ERP monotherapy. Acceptance and Commitment Therapy (ACT), which has recently been studied for OCD, offers new hope for addressing the tolerability and adherence issues with ERP. Specifically, ACT uses acceptance and mindfulness processes to foster a willingness to experience unwanted inner experiences (e.g., obsessional thoughts, anxiety). These acceptance and mindfulness processes are consistent with ERP, but they are hypothesized to increase engagement in exposure exercises beyond ERP alone. There is evidence for this claim from a randomized trial which demonstrated that ACT, without in-session exposure, had clinical response rates in the 55-65% range at posttreatment and three month follow-up using an intent to treat analysis. Additionally, drop-out and refusal rates were low at 12.2% and treatment acceptability at posttreatment was near the maximum on the scale 4.3 out of 5. In this study, for experimental reasons, ACT did not include in-session ERP. However, the most theoretically and practically consistent use of ACT for OCD is as a context from which to conduct exposure therapy or ERP. While ACT focuses on processes (e.g., acceptance, defusion, values) that are distinct from those involved in ERP (e.g., habituation, cognitive change), an important goal of both treatments is to broaden the patient's engagement with feared stimuli. In fact, ACT procedures have been shown to increase involvement in difficult activities, including participating in exposure therapy for anxiety disorders and willingness to experience unwanted obsessive thoughts. Thus, building ACT techniques into ERP is likely to help patients (a) engage in ERP tasks, (b) confront high levels of anxiety without using escape/avoidance strategies, and (c) resist rituals. The aim of the proposed study is to evaluate whether integrating ACT increases the acceptability, tolerability, and adherence with ERP techniques relative to ERP without ACT.
- STUDY DESIGN AND HYPOTHESES. Fifty-eight adults with a DSM-IV diagnosis of Obsessive-Compulsive Disorder (OCD) received 16 twice-weekly sessions (2 hours per session) of either ERP with the inclusion of ACT techniques (ERP+ACT; n = 30) or ERP alone (n = 28). Assessments using interviews, self-report questionnaires, and behavioral observations were conducted at pre- and post-test, and at 6 month follow-up. Specific hypotheses were: 1) Patients receiving ERP+ACT will report greater treatment acceptability, and show higher quantity and quality of completed self-directed ERP assignments, relative to patients receiving standard ERP; 2) Both ERP and ERP+ACT will lead to clinically significant reductions in OCD symptoms from pre- to post-test and from pre-test to follow-up.
- METHODS
3a. Sample Size and Recruitment. The investigators aimed for an intent-to-treat sample of 60 adults across two sites: The Center for Clinical Research at Utah State University (USU) and the Anxiety and Stress Disorders Clinic at the University of North Carolina, Chapel Hill (UNC). Patients were recruited via advertisement of the study and via referrals from primary care and mental health providers familiar with the treatment centers. The USU Center (Twohig) and the UNC Clinic (Abramowitz) are well known research-oriented treatment clinics in their regions. USU is within a 1:30 minute drive of two million people and travel for treatment is common given the rural nature of the area. Also, no other known entity recruits participants with OCD in this area. The Raleigh-Durham-Chapel Hill area of NC is home to over one million people, and the UNC Clinic receives a steady stream of inquiries for treatment. Patient advocacy groups and associations that post research trials on the Internet were contacted to further publicize the study.
3b. Establishing Diagnoses. All diagnoses were established by trained interviewers using the Mini International Neuropsychiatric Interview (MINI).
3c. Randomization to Treatment Groups. Subsequent to screening, 30 individuals were randomly assigned (using a random number generator) to receive ERP+ACT and 28 to receive ERP monotherapy. With the exception of the inclusion of ACT techniques in the ERP+ACT condition, treatment was identical across the two groups (i.e., the number and duration of exposure sessions were the same).
3d. Treatments. ERP. ERP treatment was manualized based on Kozak and Foa's protocol and included 16 twice-weekly 120 minute sessions. Therapists were advanced graduate students who had received extensive training from experts in ERP and ACT for OCD. Sessions 1 and 2 included information-gathering, psychoeducation, presentation of the rationale for ERP, and introduction to self-monitoring of rituals. Session 3 was dedicated to developing the treatment plan (exposure hierarchy, response prevention plan). Sessions 4-15 included in-session prolonged and repeated gradual exposure therapy, informal discussion of mistaken cognitions, daily exposure homework assignments, and instructions to refrain from rituals (response prevention in session and between sessions), along with self monitoring of any rituals that were performed. Session 16 addressed discontinuation and relapse prevention.
ACT+ERP. This condition matched the ERP condition in terms of the number and duration of exposure sessions. Sessions 1 and 2 involved an abbreviated discussion of the ACT model of ERP focusing on acceptance of obsessions and anxiety, just noticing and not acting on obsessions, being present with one's internal experiences, and linking therapy to one's values. Session 3 involved the development of an exposure hierarchy and response prevention plan, and explaining the ACT-based approach to ERP which focuses on learning flexible responding in the presence of obsessions, anxiety, and urges to ritualize. The exposure exercises were procedurally similar to ERP but focused on the facilitation of ACT processes. For example, the therapist might teach just noticing of obsessions by exposing the participant to the feared stimulus and asking the participant to watch the obsessional thoughts pass by as if they were leaves floating on a stream. Homework exposure practice was linked to the patient's goals and values, and participants were instructed to practice ACT processes during these assignments. Session 16 covered an ACT-based model of relapse prevention focusing on following one's values in the presence of obsessive thoughts and compulsive urges.
3e. Standardization and Integrity Procedures. All assessors and therapists were trained to competency in their duties by Drs. Twohig and Abramowitz. All assessment and treatment sessions were videotaped and a random selection of 20% of tapes were reviewed by the investigators and scored for integrity of implementation. Drs. Twohig and Abramowitz also served as supervisors on the project. Cross-site data and video sharing of supervision occurred via the Internet in a HIPAA-compliant manner and weekly meetings occurred via Skype.
3f. Length of Study. The length of the study was 6 years. The investigators developed the ERP+ACT treatment manual during the first two months of the study period. Following this, the investigators completed recruitment and treatment of all patients between the 1st and 6th years. This left the final 1 year for follow-up data collection, data analysis, and for writing up and presenting the results.
3g. Statistical Methods. The investigators will use the following procedures to address each hypotheses: 1) Between-groups t-tests to examine differences on measures of treatment acceptability and the quantity and quality of adherence to ERP assignments at post-treatment. Corresponding effect sizes will be computed to examine the magnitude of this effect. 2) Within-group t-tests to determine the statistical significance of pre-posttest and pretest-follow-up differences on outcome measures. Corresponding within-group effect sizes will also be computed to examine the magnitude of these differences. Further, the methods described by Jacobson \& Truax to examine the extent of clinically significant and reliable change from pre to posttest and at follow-up will be utilized.
3h. Power Analyses. Power calculations were based on the average within-group effect size of 1.41 reported in a meta-analysis of CBT for OCD. This effect size was derived from clinical interview measures (e.g., the Yale-Brown Obsessive Compulsive Scale). A sample size of 60 affords greater than 90% power to detect a similar effect size with a t-test in the present study if alpha is set at .05. There are no available studies comparing treatment adherence and quality of life between two active psychological treatments for OCD from which to calculate power estimates. The investigators will therefore examine effect sizes in addition to significance levels when comparing between ERP+ACT and ERP on these variables.
- INTENDED USE OF THE RESULTS
The results from the present study will be published and disseminated through conference presentations. They will also be used as pilot data to apply for NIMH funding for a larger study using the R34 mechanism (treatment development).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT plus ERP | Experimental | Behavioral: ACT plus ERPSessions 1 and 2 involved information-gathering, discussion of the ACT model of OCD and ERP, and introduction to self-monitoring of rituals. Session 3 involved the development of an exposure hierarchy and response prevention plan, and further explanation of the ACT-based approach to ERP which focuses on learning flexible responding in the presence of obsessions, anxiety, and urges to ritualize. Exposure practices (sessions 4-16) were procedurally similar to the ERP condition, but focused on the facilitation of ACT processes rather than on fear extinction. Homework exposure practice was linked to the participant's goals and values. Session 16 included an ACT model of relapse prevention focusing on following one's values in the presence of obsessive thoughts and compulsive urges. |
| ERP alone | Experimental | Behavioral: ERP aloneERP followed Kozak and Foa's treatment manual. Sessions 1 and 2 included information-gathering, psychoeducation about the cognitive-behavioral model of OCD and rationale for ERP, and introduction to self-monitoring of rituals. Session 3 was dedicated to developing the treatment plan (exposure hierarchy, response prevention plan). Sessions 4-16 included in-session prolonged and repeated gradual exposure therapy (in vivo and imaginal as needed), the assignment of daily exposure practices for between-sessions, and instructions to refrain from rituals (response prevention in session and between sessions), along with self monitoring of any rituals that were performed. Session 16 also addressed discontinuation and relapse prevention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current DSM-IV-TR principal diagnosis of OCD for at least 1 year
- Willing to attend all 16 therapy sessions
- Fluent in English
- No previous Cognitive Behavior Therapy or Acceptance and Commitment Therapy for OCD
- If on medication for OCD, willing to remain at a fixed dose while participating in the study
Key exclusion criteria (3 listed)
- Current severe depression or suicidal ideation
- Current substance abuse or dependence
- Current mania, psychosis, or borderline or schizotypal personality disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT plus ERP16 twice-weekly sessions of 120-minute individual psychotherapy consisting of Acceptance and Commitment Therapy plus Exposure and Response Prevention (ACT plus ERP). | Behavioural | ACT plus ERP |
| ERP alone16 twice-weekly sessions of 120-minute individual psychotherapy consisting of Exposure and Response Prevention (ERP alone) monotherapy. | Behavioural | ERP alone |
Primary outcome
Change from Baseline Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 8 weeks
Time frame: Posttreatment (8 weeks after Baseline)
Global OCD severity was measured using the Y-BOCS, a semi-structured interview that includes a symptom checklist and 10-item severity scale. The checklist is first used to identify the patient's particular obsessions and compulsions. The severity scale then assesses the main obsessions (items 1-5) and compulsions (items 6-10) on the following five parameters: (a) time, (b) interference, (c) distress, (d) resistance, and (e) degree of control. The clinician rates each item from 0 (no symptoms) to 4 (extreme) based on the past week. The 10 items are added to produce a total severity score that ranges from 0 to 40. The Y-BOCS is the most widely used measure of OCD severity and has satisfactory psychometric properties. The internal consistency (Cronbach's alpha) of the pre-treatment Y-BOCS in the present sample was .74.
Change from Posttreatment Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 6 months
Time frame: Follow-up (6 months after the end of treatment)
Global OCD severity was measured using the Y-BOCS, a semi-structured interview that includes a symptom checklist and 10-item severity scale. The checklist is first used to identify the patient's particular obsessions and compulsions. The severity scale then assesses the main obsessions (items 1-5) and compulsions (items 6-10) on the following five parameters: (a) time, (b) interference, (c) distress, (d) resistance, and (e) degree of control. The clinician rates each item from 0 (no symptoms) to 4 (extreme) based on the past week. The 10 items are added to produce a total severity score that ranges from 0 to 40. The Y-BOCS is the most widely used measure of OCD severity and has satisfactory psychometric properties. The internal consistency (Cronbach's alpha) of the pre-treatment Y-BOCS in the present sample was .74.
19 secondary outcomes
Change from Baseline Beck Depression Inventory II (BDI-II) at 8 weeks
Time frame: Posttreatment (8 weeks after Baseline)
Change from Posttreatment Beck Depression Inventory II (BDI-II) at 6 months
Time frame: Follow-up (6 months after the end of treatment)
Change from Baseline Acceptance and Action Questionnaire - II (AAQ-II) at 8 weeks
Time frame: Posttreatment (8 weeks after Baseline)
Change from Posttreatment Acceptance and Action Questionnaire - II (AAQ-II) at 6 months
Time frame: Follow-up (6 months after the end of treatment)
Session-level Change in Acceptance and Action Questionnaire - II (AAQ-II) at each session
Time frame: Sessions 1-16 (Twice per week for 8 weeks following Baseline)
Change from Baseline Distress Tolerance Scale (DTS) at 8 weeks
Time frame: Posttreatment (8 weeks after Baseline)
Change from Posttreatment Distress Tolerance Scale (DTS) at 6 months
Time frame: Follow-up (6 months after the end of treatment)
Change from Baseline Interpretation of Intrusions Inventory (III) at 8 weeks
Time frame: Posttreatment (8 weeks after Baseline)
Change from Posttreatment Interpretation of Intrusions Inventory (III) at 6 months
Time frame: Follow-up (6 months after the end of treatment)
Session-level Change in Interpretation of Intrusions Inventory (III) at each session
Time frame: Sessions 1-16 (twice per week for 8 weeks following Baseline)
Change from Baseline Believability of Anxious Feelings and Thoughts Questionnaire (BAFT) at 8 weeks
Time frame: Posttreatment (8 weeks after Baseline)
Change from Posttreatment Believability of Anxious Feelings and Thoughts Questionnaire (BAFT) at 6 months
Time frame: Follow-up (6 months after the end of treatment)
Change from Baseline Obsessive Beliefs Questionnaire (OBQ) at 8 weeks
Time frame: Posttreatment (8 weeks after Baseline)
Change from Posttreatment Obsessive Beliefs Questionnaire (OBQ) at 6 months
Time frame: Follow-up (6 months after the end of treatment)
Session-level Change in Patient EX/RP Adherence Scale - Therapist Rated at each session beginning with session 4
Time frame: Sessions 4-16 (twice per week for 6 weeks following week 2 of treatment)
Treatment Credibility and Expectancy Questionnaire
Time frame: Session 4 (2 weeks following Baseline)
Change from Baseline Dimensional Obsessive Compulsive Scale (DOCS) at 8 weeks
Time frame: Posttreatment (8 weeks after Baseline)
Change from Posttreatment Dimensional Obsessive Compulsive Scale (DOCS) at 6 months
Time frame: Follow-up (6 months after the end of treatment)
Session-level Change in Dimensional Obsessive Compulsive Scale at each session
Time frame: Sessions 1-16 (twice per week for 8 weeks following Baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Background: PubMed 20230164Abramowitz JS, Deacon BJ, Olatunji BO, Wheaton MG, Berman NC, Losardo D, Timpano KR, McGrath PB, Riemann BC, Adams T, Bjorgvinsson T, Storch EA, Hale LR. Assessment of obsessive-compulsive symptom dimensions: development and evaluation of the Dimensional Obsessive-Compulsive Scale. Psychol Assess. 2010 Mar;22(1):180-98. doi: 10.1037/a0018260.
- Background: PubMed 12699033Abramowitz JS, Foa EB, Franklin ME. Exposure and ritual prevention for obsessive-compulsive disorder: effects of intensive versus twice-weekly sessions. J Consult Clin Psychol. 2003 Apr;71(2):394-8. doi: 10.1037/0022-006x.71.2.394.
- Background: PubMed 12205821Abramowitz JS, Franklin ME, Zoellner LA, DiBernardo CL. Treatment compliance and outcome in obsessive-compulsive disorder. Behav Modif. 2002 Sep;26(4):447-63. doi: 10.1177/0145445502026004001.
- Background: PubMed 16195053Abramowitz JS, Taylor S, McKay D. Potentials and limitations of cognitive treatments for obsessive-compulsive disorder. Cogn Behav Ther. 2005;34(3):140-7. doi: 10.1080/16506070510041202.
- Background: PubMed 19665647Abramowitz JS, Taylor S, McKay D. Obsessive-compulsive disorder. Lancet. 2009 Aug 8;374(9688):491-9. doi: 10.1016/S0140-6736(09)60240-3.
- BackgroundBeck, A. T. (1996). Beck Depression Inventory (2nd ed.). San Antonio, TX: The Psychological Corporation.
- BackgroundEifert, G. H., & Forsyth, J. P. (2005). Acceptance and commitment therapy for anxiety disorders: A practitioner's treatment guide to using mindfulness, acceptance, and values-based behavior change strategies. Oakland, CA US: New Harbinger Publications.
- Background: PubMed 7802127Foa EB, Kozak MJ, Goodman WK, Hollander E, Jenike MA, Rasmussen SA. DSM-IV field trial: obsessive-compulsive disorder. Am J Psychiatry. 1995 Jan;152(1):90-6. doi: 10.1176/ajp.152.1.90.
- Background: PubMed 15625214Foa EB, Liebowitz MR, Kozak MJ, Davies S, Campeas R, Franklin ME, Huppert JD, Kjernisted K, Rowan V, Schmidt AB, Simpson HB, Tu X. Randomized, placebo-controlled trial of exposure and ritual prevention, clomipramine, and their combination in the treatment of obsessive-compulsive disorder. Am J Psychiatry. 2005 Jan;162(1):151-61. doi: 10.1176/appi.ajp.162.1.151.
- BackgroundFranklin, M. E. (2005). Combining serotonin medication with cognitive-behavior therapy: Is it necessary for all OCD patients. In J. Abramowitz & A. Houts (eds.). Concepts and controversies in obsessive-compulsive disorder (pp. 377-389). New York: Springer.
- Background: PubMed 2684084Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007.
- BackgroundHayes, S. C. (2008). Climbing our hills: A beginning conversation on the comparison of acceptance and commitment therapy and traditional cognitive behavioral therapy. Clinical Psychology: Science and Practice, 15, 286-295.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Twohig, Ph.D. principal investigator
Utah State University
Jonathan Abramowitz, Ph.D. principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT plus ERP and ERP alone in people with Obsessive-Compulsive Disorder, run by Utah State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 8 weeks (time frame: Posttreatment (8 weeks after Baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03343106, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017; AzTrials last refreshed its copy on 1 Nov 2026.