Anxiety DisordersNCT01488799
Motivational Interviewing and Cognitive Behavioural Therapy for Generalized Anxiety Disorder
A study testing Motivational Interviewing and Cognitive Behavioural Therapy in people with Anxiety Disorders and Generalized Anxiety Disorder, run by York University at 2 sites in Canada.
Trial summary
The current study examines whether change-readiness, and consequently treatment outcome, can be enhanced in Cognitive Behavioral Therapy (CBT) for severe Generalized Anxiety Disorder (GAD) by adding a brief course of Motivational Interviewing (MI adapted for anxiety, Westra \& Dozois, 2003) before and during CBT when… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Anxiety Disorders, Generalized Anxiety Disorder
- What is being tested?
- Motivational Interviewing and Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2012to Dec 2015
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Between 16 \& 65 years of age
- Proficient use of English
- A principle diagnosis of Generalized Anxiety Disorder (GAD)
- Severe GAD (as measured by clinician severity ratings and PSWQ)
- Willingness to either remain on stable dosage of psychotropic medication or remain unmedicated throughout their involvement in the clinical trial
Who cannot join
- Current of history of psychotic spectrum disorder or bipolar mood disorder
- Cognitive impairment such as neurodegenerative illness or head injury
- Current substance abuse and or dependance
- Concurrent psychotherapy, either individual or group.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
York University
Toronto, Ontario, M3J 1P3
Ryerson University
Toronto, Ontario, M5B 2K3
About this study
Official title: Adding Motivational Interviewing to Cognitive Behavioural Therapy for Severe Generalized Anxiety Disorder
The current study examines whether change-readiness, and consequently treatment outcome, can be enhanced in Cognitive Behavioral Therapy (CBT) for severe Generalized Anxiety Disorder (GAD) by adding a brief course of Motivational Interviewing (MI adapted for anxiety, Westra \& Dozois, 2003) before and during CBT when motivation wanes. 106 individuals with severe GAD will be randomly assigned to receive an equal number of sessions of either MI and CBT (MI-CBT arm) or CBT alone (CBT alone arm). It is expected that the MI-CBT arm relative to the CBT alone arm will show lower levels of resistance in CBT, higher levels of homework compliance and therapeutic alliance, better moment-to-moment interpersonal process, and consequently superior outcomes - both post-treatment and at 6 and 12 month follow-ups.
Read the detailed description
The proposed study builds on the findings of the clinical trial by Westra, Arkowitz and Dozois (2009), and aims to: (1) provide a powerful test of the value of adding MI to CBT for high severity GAD (as pilot data has indicated that individuals with severe GAD may preferentially benefit from the addition of MI to CBT), (2) employ treatment procedures generalizable to clinical practice, and (3) examine the mechanisms underlying any additive treatment benefit. 106 individuals with a principal diagnosis of GAD and of high worry severity will be randomly assigned to receive either 4 sessions of MI followed by 11 sessions of CBT (MI-CBT arm) or 15 sessions of CBT (CBT alone arm). Both groups will also receive 2 follow-up CBT treatment sessions at 1 and 3 months post-treatment. Each therapist will deliver all treatment components, treatments will appear seamless to clients, and therapists will be nested within treatment group to control for allegiance effects and avoid cross-contamination of the therapies. In order to increase generalizability to clinical practice, in the CBT phase for the MI-CBT arm, therapists will shift to MI in the presence of empirically derived markers of resistance and shift back to CBT when resistance has diminished. In the CBT alone arm therapists will respond to resistance using manualized recommendations derived from leading CBT theorists for the management of resistance. Anxiety and related symptoms, motivation, and treatment engagement will be assessed at various points during treatment, and at 6 and 12 months post-treatment. A multi-method approach to assessment will be used, including self-report, clinician-report, clinician-administered, observer-rated, and interview-based measures. Importantly, we will include not only traditional outcome measures, but also process measures (e.g., observer-coded interpersonal behavior, interview-based derivation of client experiences) to investigate possible mechanisms underlying any additive treatment benefit. In addition, all therapy sessions will be videotaped and assessed by independent raters for protocol adherence.
The specific hypotheses are as followed:
Hypothesis 1: Worry, Anxiety, \& Related Symptoms. The MI-CBT arm will show greater reductions in worry, anxiety, and related symptoms (depression, disability, maladaptive beliefs about worry, life satisfaction) and a greater percentage of treatment responders (using clinical significance criteria) across the treatment period and at follow-up (FU), compared to the CBT alone arm.
Hypothesis 2: Motivation and Resistance. Over the course of early treatment (i.e., sessions 1 to 4), the MI-CBT arm will demonstrate greater increases in motivation compared to the CBT alone arm. In addition, the MI-CBT arm will exhibit lower in-session resistance during early (sessions 5 \& 7), middle (sessions 10 \& 12), and late (sessions 15 \& 17) phases of treatment.
Hypothesis 3: Homework Compliance. The MI-CBT arm will show greater client- and therapist-rated homework compliance throughout CBT treatment compared to the CBT alone arm.
Hypothesis 4a: Interpersonal Processes between Clients and Therapists. Compared to CBT alone clients, MI-CBT clients and therapists will report higher working alliance quality during both the initial MI sessions and subsequent phases of CBT. Furthermore, moment-to-moment interpersonal processes between client and therapist during early, middle, and late treatment are expected to be characterized by more adaptive processes (e.g., higher affiliation and less hostility) in the MI-CBT vs. CBT alone arms.
Hypothesis 4b. Interpersonal Processes During Resistance. During episodes of client resistance (identified with resistance coding), therapist and client exchanges in MI-CBT are expected to be characterized by more adaptive processes (i.e., higher affiliation, less hostility, and greater client autonomy-preservation) compared to CBT alone. Further, when a small subset of clients (5 per treatment group) are interviewed about their experiences of resistance episodes, we expect client accounts in the MI-CBT arm to be characterized more positively (e.g., more supportive of client autonomy, more conducive to increased engagement vs. disengagement with treatment) compared to CBT alone.
Hypothesis 5: Mediation of Therapeutic Outcomes. We expect that increased motivation and reduced resistance in MI-CBT, compared to CBT alone, will lead to higher levels of engagement in the CBT (better homework compliance and therapeutic alliance), which will result in greater worry reduction.
- Conditions
- Anxiety Disorders, Generalized Anxiety Disorder
- Being tested
- Motivational Interviewing and Cognitive Behavioural Therapy
- Keywords
- Anxiety, Generalized Anxiety Disorder, Motivational Interviewing, Cognitive Behavioural Therapy, Psychotherapy
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing and Cognitive Behavioural TherapyBehavioural
Also called Motivational Interviewing, Cognitive Behavioral Therapy
Participants with a diagnosis of severe Generalized Anxiety Disorder will be randomly assigned to receive either 4 weekly sessions of MI followed by 11 weekly sessions of CBT (MI-CBT arm) or 15 weekly sessions of CBT (CBT alone arm). Both groups will also receive 2 follow-up CBT treatment sessions at 1 and 3 months post-treatment. In order to increase generalizability to clinical practice, in the CBT phase for the MI-CBT arm, therapists will shift to MI in the presence of empirically derived markers of resistance and shift back to CBT when resistance has diminished. In the CBT alone arm therapists will respond to resistance using manualized recommendations derived from leading CBT theorists for the management of resistance.
| Study group | Role | What they receive |
|---|---|---|
| MI-CBT | Active comparator | Not described Receives: Behavioral: Motivational Interviewing and Cognitive Behavioural Therapy |
| CBT alone | Active comparator | Not described Receives: Behavioral: Motivational Interviewing and Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penn State Worry Questionnaire (PSWQ)
The Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990) is a widely used measure of worry in GAD treatment outcome studies. It is a 16-item scale assessing trait worry. The PSWQ has been found to possess high internal consistency and temporal stability, as well as good convergent and discriminant validity. It also differentiates individuals with GAD from those with other anxiety disorders (Brown et al., 1992).
Measured: up to 4 years
Secondary outcomes (3)
Satisfaction with Life Scale (SWLS)
The Satisfaction with Life Scale (SWLS; Diener et al., 1985)is a 5-item scale that is a widely used as a measure of life satisfaction with high internal validity, temporal stability, and sensitivity to change, as well as good convergent and divergent validity.
Measured: up to 4 years
Inventory of Interpersonal Problems (IIP)
The Inventory of Interpersonal Problems (IIP; Horowitz, Rosenberg, Baer, Ureño, \& Villaseñor, 1988), scale has been shown to discriminate among different categories of personality disorders and reliably tap into three dimensions of the the interpersonal relational field (Gude, Moum, Kaldestad, \& Friis, 2000).
Measured: up to 4 years
Depression Anxiety Stress Scale (DASS)
The Depression Anxiety Stress Scale (DASS; Lovibond \& Lovibond, 1995) is a set of three self-report scales designed to define, measure and understand depression, anxiety and stress. Each scale contains 14 items, for a total of 42 items, and each scale is divided into sub-scales of 2-5 items based on content. The DASS shows strong consistent reliability in distinguishing between features of depression, anxiety and stress (Antony, Bieling, Cox, Enns, Murray \& Swinson, 1998).
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Metropolitan University, University of Massachusetts, Amherst
- Responsible party
- Principal investigator, Henny Westra, York University
- Investigators
- Henny A Westra, Ph.D., Principal investigator, York UniversityMartin M Antony, Ph.D., Principal investigator, Toronto Metropolitan UniversityMichael J Constantino, Ph.D., Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488799
- Sponsor's protocol ID
- MOP114909
- Status last verified
- Dec 2015
- First submitted
- 6 Dec 2011
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Motivational Interviewing to Cognitive Behavioural Therapy for Severe Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT01488799
- Acronym / sponsor ID
- MOP114909
- Conditions
- Anxiety Disorders, Generalized Anxiety Disorder
- Keywords
- Anxiety, Generalized Anxiety Disorder, Motivational Interviewing, Cognitive Behavioural Therapy, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- Toronto Metropolitan University, University of Massachusetts, Amherst
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Dec 2011 (estimated)
- 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 current study examines whether change-readiness, and consequently treatment outcome, can be enhanced in Cognitive Behavioral Therapy (CBT) for severe Generalized Anxiety Disorder (GAD) by adding a brief course of Motivational Interviewing (MI adapted for anxiety, Westra \& Dozois, 2003) before and during CBT when motivation wanes. 106 individuals with severe GAD will be randomly assigned to receive an equal number of sessions of either MI and CBT (MI-CBT arm) or CBT alone (CBT alone arm). It is expected that the MI-CBT arm relative to the CBT alone arm will show lower levels of resistance in CBT, higher levels of homework compliance and therapeutic alliance, better moment-to-moment interpersonal process, and consequently superior outcomes - both post-treatment and at 6 and 12 month follow-ups.
Detailed description
The proposed study builds on the findings of the clinical trial by Westra, Arkowitz and Dozois (2009), and aims to: (1) provide a powerful test of the value of adding MI to CBT for high severity GAD (as pilot data has indicated that individuals with severe GAD may preferentially benefit from the addition of MI to CBT), (2) employ treatment procedures generalizable to clinical practice, and (3) examine the mechanisms underlying any additive treatment benefit. 106 individuals with a principal diagnosis of GAD and of high worry severity will be randomly assigned to receive either 4 sessions of MI followed by 11 sessions of CBT (MI-CBT arm) or 15 sessions of CBT (CBT alone arm). Both groups will also receive 2 follow-up CBT treatment sessions at 1 and 3 months post-treatment. Each therapist will deliver all treatment components, treatments will appear seamless to clients, and therapists will be nested within treatment group to control for allegiance effects and avoid cross-contamination of the therapies. In order to increase generalizability to clinical practice, in the CBT phase for the MI-CBT arm, therapists will shift to MI in the presence of empirically derived markers of resistance and shift back to CBT when resistance has diminished. In the CBT alone arm therapists will respond to resistance using manualized recommendations derived from leading CBT theorists for the management of resistance. Anxiety and related symptoms, motivation, and treatment engagement will be assessed at various points during treatment, and at 6 and 12 months post-treatment. A multi-method approach to assessment will be used, including self-report, clinician-report, clinician-administered, observer-rated, and interview-based measures. Importantly, we will include not only traditional outcome measures, but also process measures (e.g., observer-coded interpersonal behavior, interview-based derivation of client experiences) to investigate possible mechanisms underlying any additive treatment benefit. In addition, all therapy sessions will be videotaped and assessed by independent raters for protocol adherence.
The specific hypotheses are as followed:
Hypothesis 1: Worry, Anxiety, \& Related Symptoms. The MI-CBT arm will show greater reductions in worry, anxiety, and related symptoms (depression, disability, maladaptive beliefs about worry, life satisfaction) and a greater percentage of treatment responders (using clinical significance criteria) across the treatment period and at follow-up (FU), compared to the CBT alone arm.
Hypothesis 2: Motivation and Resistance. Over the course of early treatment (i.e., sessions 1 to 4), the MI-CBT arm will demonstrate greater increases in motivation compared to the CBT alone arm. In addition, the MI-CBT arm will exhibit lower in-session resistance during early (sessions 5 \& 7), middle (sessions 10 \& 12), and late (sessions 15 \& 17) phases of treatment.
Hypothesis 3: Homework Compliance. The MI-CBT arm will show greater client- and therapist-rated homework compliance throughout CBT treatment compared to the CBT alone arm.
Hypothesis 4a: Interpersonal Processes between Clients and Therapists. Compared to CBT alone clients, MI-CBT clients and therapists will report higher working alliance quality during both the initial MI sessions and subsequent phases of CBT. Furthermore, moment-to-moment interpersonal processes between client and therapist during early, middle, and late treatment are expected to be characterized by more adaptive processes (e.g., higher affiliation and less hostility) in the MI-CBT vs. CBT alone arms.
Hypothesis 4b. Interpersonal Processes During Resistance. During episodes of client resistance (identified with resistance coding), therapist and client exchanges in MI-CBT are expected to be characterized by more adaptive processes (i.e., higher affiliation, less hostility, and greater client autonomy-preservation) compared to CBT alone. Further, when a small subset of clients (5 per treatment group) are interviewed about their experiences of resistance episodes, we expect client accounts in the MI-CBT arm to be characterized more positively (e.g., more supportive of client autonomy, more conducive to increased engagement vs. disengagement with treatment) compared to CBT alone.
Hypothesis 5: Mediation of Therapeutic Outcomes. We expect that increased motivation and reduced resistance in MI-CBT, compared to CBT alone, will lead to higher levels of engagement in the CBT (better homework compliance and therapeutic alliance), which will result in greater worry reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI-CBT | Active comparator | Behavioral: Motivational Interviewing and Cognitive Behavioural Therapy |
| CBT alone | Active comparator | Behavioral: Motivational Interviewing and Cognitive Behavioural Therapy |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Between 16 \& 65 years of age
- Proficient use of English
- A principle diagnosis of Generalized Anxiety Disorder (GAD)
- Severe GAD (as measured by clinician severity ratings and PSWQ)
- Willingness to either remain on stable dosage of psychotropic medication or remain unmedicated throughout their involvement in the clinical trial
Key exclusion criteria (4 listed)
- Current of history of psychotic spectrum disorder or bipolar mood disorder
- Cognitive impairment such as neurodegenerative illness or head injury
- Current substance abuse and or dependance
- Concurrent psychotherapy, either individual or group.
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 |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioural TherapyAlso: Motivational Interviewing, Cognitive Behavioral TherapyParticipants with a diagnosis of severe Generalized Anxiety Disorder will be randomly assigned to receive either 4 weekly sessions of MI followed by 11 weekly sessions of CBT (MI-CBT arm) or 15 weekly sessions of CBT (CBT alone arm). Both groups will also receive 2 follow-up CBT treatment sessions at 1 and 3 months post-treatment. In order to increase generalizability to clinical practice, in the CBT phase for the MI-CBT arm, therapists will shift to MI in the presence of empirically derived markers of resistance and shift back to CBT when resistance has diminished. In the CBT alone arm therapists will respond to resistance using manualized recommendations derived from leading CBT theorists for the management of resistance. | Behavioural | CBT alone, MI-CBT |
Primary outcome
Penn State Worry Questionnaire (PSWQ)
Time frame: up to 4 years
The Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990) is a widely used measure of worry in GAD treatment outcome studies. It is a 16-item scale assessing trait worry. The PSWQ has been found to possess high internal consistency and temporal stability, as well as good convergent and discriminant validity. It also differentiates individuals with GAD from those with other anxiety disorders (Brown et al., 1992).
3 secondary outcomes
Satisfaction with Life Scale (SWLS)
Time frame: up to 4 years
Inventory of Interpersonal Problems (IIP)
Time frame: up to 4 years
Depression Anxiety Stress Scale (DASS)
Time frame: up to 4 years
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 29 Dec 2015.
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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.
Henny A Westra, Ph.D. principal investigator
York University
Martin M Antony, Ph.D. principal investigator
Toronto Metropolitan University
Michael J Constantino, Ph.D. principal investigator
University of Massachusetts, Worcester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Cognitive Behavioural Therapy in people with Anxiety Disorders and Generalized Anxiety Disorder, run by York University at 2 sites in Canada.
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 4 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 29 Dec 2015. 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 Canada. 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?
Penn State Worry Questionnaire (PSWQ) (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2015.