Chronic PainPhase 2TTCPNCT01055639
Telehealth Therapy for Chronic Pain: Comparison of In-person vs. Video-administered ACT for Pain
A Phase 2 study testing In-Person ACT and Telehealth ACT in people with Chronic Pain, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of the study is to test a brief, individual psychosocial in-person or telehealth intervention to reduce interference of pain with daily life, emotional distress, and pain intensity, and improve quality of life and physical activity levels in individuals with chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- In-Person ACT and Telehealth ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Sep 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic non-terminal pain condition;
- Pain severity and interference rated > 4/10; and
- Pain most days (> 3/week) for at least 6 months.
Who cannot join
- Current participation in group psychotherapy for pain or any type of individual psychotherapy;
- Previous treatment with ACT;
- Active suicide ideation or history of suicide attempt within 5 years;
- Serious or unstable medical or psychiatric illness or psychosocial instability that could compromise study participation; and
- The following DSM-IV diagnoses or active problems within the past 6 months noted in the patient's Computerized Patient Record System (CPRS) medical record or diagnosed during a structured psychiatric interview:
- schizophrenia;
Show all 11Show fewer
- other psychotic disorder;
- bipolar disorder;
- organic mental disorder;
- borderline or antisocial personality disorder; or
- alcohol or substance abuse or dependence.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego
San Diego, California, 92161
About this study
Official title: Telehealth Therapy for Chronic Pain
The purpose of the study is to test a brief, individual psychosocial in-person or telehealth intervention to reduce interference of pain with daily life, emotional distress, and pain intensity, and improve quality of life and physical activity levels in individuals with chronic pain.
Read the detailed description
Chronic pain affects at least 15% of the veteran population and represents a high priority for the VA. In addition to primary pain conditions, chronic pain is a common secondary condition resulting from battlefield injuries, traumatic accidents, and congenital and acquired disorders. Unlike most forms of acute pain, treatment options available for patients suffering from chronic pain frequently offer only short-term or partial relief from symptoms. The focus of rehabilitative intervention thus becomes the reduction of disability and emotional distress and improvement in quality of life and activity levels.
Chronic pain rehabilitation has evolved from a primarily one dimensional, medically oriented approach to a multidisciplinary approach that incorporates a biopsychosocial formulation to pain management with physiological, cognitive, behavioral, and emotional components. This conceptualization of pain recognizes that multiple intervention modalities, including psychosocial approaches, are required when providing treatment to chronic pain patients.
A relatively new psychosocial approach to chronic pain management and rehabilitation involves acceptance of pain-related experiences. The Acceptance and Commitment Therapy (ACT) model is based on the theory that attempts to escape, avoid, or control negative experiences that cannot be changed, such as chronic pain, may paradoxically contribute to the increased experience of them. Instead of seeking to control the negative experience, ACT teaches individuals to use mindfulness strategies to enlarge the scope of experience beyond pain and to engage in behaviors that are consistent with personal values and goals when total elimination of pain or other negative experiences is not possible. Empirical support for acceptance-based approaches to chronic pain management is growing. Data from one of the first comparisons of ACT to a well-established psychosocial intervention, Cognitive-Behavioral Therapy (CBT), performed at the VA San Diego Healthcare System (VASDHS) by the PI, suggests that ACT may be superior to CBT as an adjunctive treatment for chronic pain.
The proposed study assembles a multidisciplinary team with extensive experience in chronic pain interventions research to evaluate the benefits of a brief, individual psychosocial in-person or telehealth intervention which could be easily integrated into multidisciplinary pain rehabilitation programs throughout the VA system to reduce disability in veterans with chronic pain secondary to other conditions. Specifically, we propose to examine the effects of a promising new chronic pain intervention based on ACT principles on the primary outcome of pain interference and secondary outcomes of emotional distress, quality of life, physical activity, pain intensity, and treatment satisfaction among 196 veterans with chronic benign pain as a secondary condition. The participants are randomized to between-subjects design where in-person ACT intervention will be compared with telehealth ACT intervention. Outcomes include an objective measure of physical activity, actigraphy, as well as self-reported measures and will be evaluated at baseline, 4 weeks, 8 weeks (end of treatment), 3-month follow-up and at a 6-month follow-up period to investigate maintenance of gains. Telehealth sessions are conducted using secure video-conferencing equipment at the most convenient clinic for the participant. Thus, the proposed project has the potential to enhance the current VA standard of care as well as to add to the scientific literature on psychological models and rehabilitation of chronic pain.
- Conditions
- Chronic Pain
- Being tested
- In-Person ACT, Telehealth ACT
- Keywords
- Chronic Pain, Acceptance and Commitment Therapy (ACT)
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Person ACTBehavioural
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
Telehealth ACTBehavioural
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
| Study group | Role | What they receive |
|---|---|---|
| In-person ACT | Active comparator | 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change. Receives: Behavioral: In-Person ACT |
| Telehealth ACT | Experimental | 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change. Receives: Behavioral: Telehealth ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory-interference Subscale
The primary outcome measure for the proposed study is the Brief Pain Inventory Short Form Interference subscale (BPI; Cleeland \& Ryan, 1994). This 7-item scale, recommended by the IMMPACT group as a measure of functioning (Dworkin et al., 2005), measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Scores range from 0 (least interference due to pain) to 10 (most interference due to pain).
Measured: 8 weeks
Secondary outcomes (8)
Brief Pain Inventory-severity Subscale
The Brief Pain Inventory Short Form (BPI; Cleeland \& Ryan, 1994) includes a 4-item pain severity subscale measuring the level of pain over the past week on average, at its worst, at its least, and currently. This measure is recommended by the IMMPACT group as a pain assessment tool (Dworkin et al., 2005). Scores range from 0 (least pain severity) to 10 (most pain severity).
Measured: 8 weeks
West Haven-Yale Multidimensional Pain Inventory - Activity Subscales
The West Haven-Yale Multidimensional Pain Inventory (MPI; Kerns et al., 1985) contains 52 items forming 12 subscales. For this study, we used four subscales assessing various types of activities. Household Chores (5 items); Outdoor Work (5 items); Activities Away From Home (4 items); and Social Activities (4 items). The MPI has been used extensively in outcome research with heterogeneous samples of chronic pain patients, including veterans, and has demonstrated sensitivity to treatment change (Altmaier et al., 1992; Mikail et al., 1993). Individual items are rated on a 7-point Likert scale from 0-6, and subscales are scored by averaging items together. Therefore, the score for Part III, General Activity, is composed of an average of the 18 items in the Household Chores (5 items); Outdoor Work (5 items); Activities Away From Home (4 items); and Social Activities (4 items) subscales. The final score ranges from 0 (lowest level of activity) to 6 (highest level of activity).
Measured: 8 weeks
SF-12 MCS
6-item self-report measure of mental health-related quality of life. Subscale of the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12; Ware et al., 1994). This measure is widely used with populations with chronic disease. The Physical and Mental Component Summary scores correlate .91 and .92 with the corresponding scores derived from the SF-36, and 2-week test-retest reliability correlations were .89 and .76 (Ware et al., 1994). The Short Form Health Survey is recommended by the IMMPACT group (Dworkin et al., 2005). Scores range from 0 (lowest functioning) to 100 (highest functioning).
Measured: 8 weeks
SF-12 PCS
Physical health-related quality of life will be measured using the Physical Component Summary score of the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12; Ware et al., 1994). This measure is widely used with populations with chronic disease. The Physical and Mental Component Summary scores correlate .91 and .92 with the corresponding scores derived from the SF-36, and 2-week test-retest reliability correlations were .89 and .76 (Ware et al., 1994). The Short Form Health Survey is recommended by the IMMPACT group (Dworkin et al., 2005). Scores range from 0 (lowest functioning) to 100 (highest functioning).
Measured: 8 weeks
Patient Health Questionnaire-9
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The tool rates the frequency of the symptoms which factors into the scoring severity index. Scores range from 0 (lowest level of depressive symptoms) to 27 (highest level of depressive symptoms).
Measured: 8 weeks
Pain Anxiety Symptom Scale - 20
Anxiety will be assessed with the 20-item Pain Anxiety Symptoms Scale-Short Form (PASS-20; McCracken \& Dhingra, 2002). Pain anxiety captures fears patients associate with their symptoms, which are typically associated with the belief that their pain signals harm. High levels of pain anxiety compromise patient's activity levels, participation in rehabilitation, and performance on functional tests. The instrument is a valid and reliable measure of anxiety symptoms in pain populations (McCracken et al., 1996; Roelofs et al., 2004). The PASS-20 items are scored on a 6-point Likert scale and assess cognitive, escape/avoidance, fear, and physiological anxiety dimensions. Internal consistency is high and correlation between the short and long form is excellent (alpha=.81; r=.97). This measure has been recommended by the VA and demonstrated sensitivity to treatment in the pilot sample (National VA Pain Outcomes Working Group, 2003). Scores range from 0 (least anxiety) to 100 (most anxiety).
Measured: 8 weeks
PTSD Checklist
The 17-item PTSD Checklist (Weathers et al., 1994) will be used to assess PTSD symptoms. In combat veterans, this questionnaire has high test-retest reliability (0.96) and validity as indicated by a kappa of 0.64 for diagnosis of PTSD using the SCID (Weathers et al., 1993). Scores range from 17 (low PTSD) to 85 (high PTSD).
Measured: 8 weeks
Pittsburgh Sleep Quality Index
The 19-item Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) is the most commonly used measure of self-rated sleep quality, with good reliability (alpha = .83, test-retest = .85) and validity (kappa = 0.75) for distinguishing good and poor sleepers. A survey recently conducted by the IMMPACT group indicated that sleep is one of the domains most important to patients with chronic pain (Turk et al., 2008), and the PSQI is the scale most frequently used to evaluate sleep quality in studies of chronic pain patients (Cole et al., 2007). Scores range from 0 (good sleep) to 42 (poor sleep).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julie L Wetherell, PhD, Principal investigator, VA San Diego Healthcare System, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055639
- Sponsor's protocol ID
- F6891-R
- Other IDs
- 091019
- Acronym
- TTCP
- Status last verified
- Jun 2015
- First submitted
- 21 Jan 2010
- Last updated
- 12 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Herbert MS, Afari N, Liu L, Heppner P, Rutledge T, Williams K, Eraly S, VanBuskirk K, Nguyen C, Bondi M, Atkinson JH, Golshan S, Wetherell JL. Telehealth Versus In-Person Acceptance and Commitment Therapy for Chronic Pain: A Randomized Noninferiority Trial. J Pain. 2017 Feb;18(2):200-211. doi: 10.1016/j.jpain.2016.10.014. Epub 2016 Nov 9.
PubMed 27838498
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Therapy for Chronic Pain
- ClinicalTrials.gov ID
- NCT01055639
- Acronym / sponsor ID
- TTCP / F6891-R
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Acceptance and Commitment Therapy (ACT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Feb 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 25 Jan 2010 (estimated)
- Results
- Posted 12 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to test a brief, individual psychosocial in-person or telehealth intervention to reduce interference of pain with daily life, emotional distress, and pain intensity, and improve quality of life and physical activity levels in individuals with chronic pain.
Detailed description
Chronic pain affects at least 15% of the veteran population and represents a high priority for the VA. In addition to primary pain conditions, chronic pain is a common secondary condition resulting from battlefield injuries, traumatic accidents, and congenital and acquired disorders. Unlike most forms of acute pain, treatment options available for patients suffering from chronic pain frequently offer only short-term or partial relief from symptoms. The focus of rehabilitative intervention thus becomes the reduction of disability and emotional distress and improvement in quality of life and activity levels.
Chronic pain rehabilitation has evolved from a primarily one dimensional, medically oriented approach to a multidisciplinary approach that incorporates a biopsychosocial formulation to pain management with physiological, cognitive, behavioral, and emotional components. This conceptualization of pain recognizes that multiple intervention modalities, including psychosocial approaches, are required when providing treatment to chronic pain patients.
A relatively new psychosocial approach to chronic pain management and rehabilitation involves acceptance of pain-related experiences. The Acceptance and Commitment Therapy (ACT) model is based on the theory that attempts to escape, avoid, or control negative experiences that cannot be changed, such as chronic pain, may paradoxically contribute to the increased experience of them. Instead of seeking to control the negative experience, ACT teaches individuals to use mindfulness strategies to enlarge the scope of experience beyond pain and to engage in behaviors that are consistent with personal values and goals when total elimination of pain or other negative experiences is not possible. Empirical support for acceptance-based approaches to chronic pain management is growing. Data from one of the first comparisons of ACT to a well-established psychosocial intervention, Cognitive-Behavioral Therapy (CBT), performed at the VA San Diego Healthcare System (VASDHS) by the PI, suggests that ACT may be superior to CBT as an adjunctive treatment for chronic pain.
The proposed study assembles a multidisciplinary team with extensive experience in chronic pain interventions research to evaluate the benefits of a brief, individual psychosocial in-person or telehealth intervention which could be easily integrated into multidisciplinary pain rehabilitation programs throughout the VA system to reduce disability in veterans with chronic pain secondary to other conditions. Specifically, we propose to examine the effects of a promising new chronic pain intervention based on ACT principles on the primary outcome of pain interference and secondary outcomes of emotional distress, quality of life, physical activity, pain intensity, and treatment satisfaction among 196 veterans with chronic benign pain as a secondary condition. The participants are randomized to between-subjects design where in-person ACT intervention will be compared with telehealth ACT intervention. Outcomes include an objective measure of physical activity, actigraphy, as well as self-reported measures and will be evaluated at baseline, 4 weeks, 8 weeks (end of treatment), 3-month follow-up and at a 6-month follow-up period to investigate maintenance of gains. Telehealth sessions are conducted using secure video-conferencing equipment at the most convenient clinic for the participant. Thus, the proposed project has the potential to enhance the current VA standard of care as well as to add to the scientific literature on psychological models and rehabilitation of chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person ACT | Active comparator | Behavioral: In-Person ACT8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change. |
| Telehealth ACT | Experimental | Behavioral: Telehealth ACT8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic non-terminal pain condition;
- Pain severity and interference rated > 4/10; and
- Pain most days (> 3/week) for at least 6 months.
Key exclusion criteria (11 listed)
- Current participation in group psychotherapy for pain or any type of individual psychotherapy;
- Previous treatment with ACT;
- Active suicide ideation or history of suicide attempt within 5 years;
- Serious or unstable medical or psychiatric illness or psychosocial instability that could compromise study participation; and
- The following DSM-IV diagnoses or active problems within the past 6 months noted in the patient's Computerized Patient Record System (CPRS) medical record or diagnosed during a structured psychiatric interview:
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 |
|---|---|---|
| In-Person ACT8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action | Behavioural | In-person ACT |
| Telehealth ACT8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action | Behavioural | Telehealth ACT |
Primary outcome
Brief Pain Inventory-interference Subscale
Time frame: 8 weeks
The primary outcome measure for the proposed study is the Brief Pain Inventory Short Form Interference subscale (BPI; Cleeland \& Ryan, 1994). This 7-item scale, recommended by the IMMPACT group as a measure of functioning (Dworkin et al., 2005), measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Scores range from 0 (least interference due to pain) to 10 (most interference due to pain).
8 secondary outcomes
Brief Pain Inventory-severity Subscale
Time frame: 8 weeks
West Haven-Yale Multidimensional Pain Inventory - Activity Subscales
Time frame: 8 weeks
SF-12 MCS
Time frame: 8 weeks
SF-12 PCS
Time frame: 8 weeks
Patient Health Questionnaire-9
Time frame: 8 weeks
Pain Anxiety Symptom Scale - 20
Time frame: 8 weeks
PTSD Checklist
Time frame: 8 weeks
Pittsburgh Sleep Quality Index
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27838498Herbert MS, Afari N, Liu L, Heppner P, Rutledge T, Williams K, Eraly S, VanBuskirk K, Nguyen C, Bondi M, Atkinson JH, Golshan S, Wetherell JL. Telehealth Versus In-Person Acceptance and Commitment Therapy for Chronic Pain: A Randomized Noninferiority Trial. J Pain. 2017 Feb;18(2):200-211. doi: 10.1016/j.jpain.2016.10.014. Epub 2016 Nov 9.
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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.
Julie L Wetherell, PhD principal investigator
VA San Diego Healthcare System, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing In-Person ACT and Telehealth ACT in people with Chronic Pain, run by VA Office of Research and Development at 1 site 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 3 inclusion and 11 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 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Brief Pain Inventory-interference Subscale (time frame: 8 weeks). 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 NCT01055639, which also lists 1 linked publication.
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 12 Aug 2016.