Brief Cognitive Behavioral Therapy for Chronic Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 3/9/2019 |
| Start Date: | October 1, 2018 |
| End Date: | April 30, 2020 |
| Contact: | Gregory P Beehler, PhD |
| Email: | Gregory.Beehler@va.gov |
| Phone: | (716) 862-7934 |
RCT of Brief Cognitive Behavioral Therapy for Chronic Pain
To address the gap in treatment options for Veterans with chronic pain in primary care, the
investigators have developed an abbreviated version of cognitive behavioral therapy, Brief
Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP), specifically for use in
integrated care settings. The first objective of the proposed study is to conduct a pilot
randomized controlled trial of Brief CBT-CP compared to primary care treatment as usual to
assess feasibility (i.e., recruitment and retention of participants, appropriateness of
measures, and assessment of fidelity of service delivery). This trial will also preliminarily
assess treatment effectiveness by examining changes in pain-related physical interference,
psychological distress, pain intensity, and other related outcomes. Thirty eligible
participants will be randomized into either Brief CBT-CP and primary care treatment as usual
or primary care treatment as usual only. Eligible Veterans will include those with chronic
musculoskeletal pain and pain-related functional impairment identified from primary care.
Participants assigned to Brief CBT-CP will receive six weekly sessions of treatment in
30-minute appointments. This intervention will include education and goal setting, activities
and pacing, relaxation skills, cognitive coping, and relapse prevention. Assessments will
include validated self-report measures that will take place at pre-treatment (baseline),
post-treatment, and at 12-week follow-up. The second objective of this study will be to
explore patient and provider perceptions of Brief CBT-CP to identify potential modifications
that will improve its quality and overall feasibility of delivery in future work.
Participants will include up to 12 staff members as well as up to 12 patients who were
randomized to Brief CBT-CP. Participants will be interviewed by telephone about key
components of the treatment. Participants will comment on the protocol and study procedures
in terms of acceptability (the perception that a treatment is agreeable or that its specific
components are satisfactory), appropriateness (the perceived fit or compatibility of the
intervention for a given provider or consumer), and feasibility (the extent to which a new
treatment can be successfully carried out or is suitable for everyday use). This intervention
has been designed specifically for integrated care providers and therefore has clear
implications for translation to clinical practice and for improving pain care quality by
providing an evidence-based protocol. The potential direct benefit to Veterans includes
offering a safe, accessible, non-pharmacological treatment for chronic pain early in the
trajectory of VA care.
investigators have developed an abbreviated version of cognitive behavioral therapy, Brief
Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP), specifically for use in
integrated care settings. The first objective of the proposed study is to conduct a pilot
randomized controlled trial of Brief CBT-CP compared to primary care treatment as usual to
assess feasibility (i.e., recruitment and retention of participants, appropriateness of
measures, and assessment of fidelity of service delivery). This trial will also preliminarily
assess treatment effectiveness by examining changes in pain-related physical interference,
psychological distress, pain intensity, and other related outcomes. Thirty eligible
participants will be randomized into either Brief CBT-CP and primary care treatment as usual
or primary care treatment as usual only. Eligible Veterans will include those with chronic
musculoskeletal pain and pain-related functional impairment identified from primary care.
Participants assigned to Brief CBT-CP will receive six weekly sessions of treatment in
30-minute appointments. This intervention will include education and goal setting, activities
and pacing, relaxation skills, cognitive coping, and relapse prevention. Assessments will
include validated self-report measures that will take place at pre-treatment (baseline),
post-treatment, and at 12-week follow-up. The second objective of this study will be to
explore patient and provider perceptions of Brief CBT-CP to identify potential modifications
that will improve its quality and overall feasibility of delivery in future work.
Participants will include up to 12 staff members as well as up to 12 patients who were
randomized to Brief CBT-CP. Participants will be interviewed by telephone about key
components of the treatment. Participants will comment on the protocol and study procedures
in terms of acceptability (the perception that a treatment is agreeable or that its specific
components are satisfactory), appropriateness (the perceived fit or compatibility of the
intervention for a given provider or consumer), and feasibility (the extent to which a new
treatment can be successfully carried out or is suitable for everyday use). This intervention
has been designed specifically for integrated care providers and therefore has clear
implications for translation to clinical practice and for improving pain care quality by
providing an evidence-based protocol. The potential direct benefit to Veterans includes
offering a safe, accessible, non-pharmacological treatment for chronic pain early in the
trajectory of VA care.
We will recruit 30 Veterans from the primary care clinics located at the Buffalo VAMC in
Buffalo, NY. Thirty eligible participants will be randomized in a 1:1 ratio into either (1)
Brief CBT-CP plus TAU or (2) TAU only. We will engage in recruitment during the second
quarter of Year 1 through the end of the first quarter of Year 2. We aim to recruit and
enroll 7-8 participants per quarter during that time frame. Post-treatment follow-up will be
conducted at eight weeks and at 12 weeks. Two recruitment methods will be used. Veterans with
chronic musculoskeletal pain who self-report functional impairment will be referred by their
PACT, in response to a recruitment flyer posted in primary care, or by contacting the PI or
study staff directly after hearing of the study by word of mouth or other sources. This
approach will be supplemented by a case-finding procedure in which study staff review
electronic medical record data to identify potential patients, who will be subsequently
contacted by letter and screened by telephone. Following telephone screening, potentially
eligible participants will complete a baseline assessment to assess pain and related
characteristics as well as remaining exclusion criteria. Those passing baseline measures will
be randomized to (1) Brief CBT-CP plus TAU or (2) TAU only. Assignment to Brief CBT-CP will
be stratified based on degree of pain interference.
Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course
of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix.
Session one focuses on foundational pain education and the development of treatment goals.
Session two emphasizes balanced engagement in physical activity and pleasurable events.
Session three emphasizes skills training for easily implemented relaxation techniques.
Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively
impact pain. Session six focuses on relapse prevention and independent implementation of
CBT-CP skills following treatment. Brief CBT-CP will be delivered by a masters-level
interventionist either at the Buffalo VA Medical Center or by telephone depending on the
preference of the participant.
Participants assigned to TAU only will receive standard medical care from their primary care
provider including pain medications, brief advice (e.g., use of relative rest, application of
heat or ice, other self-care strategies), or referral to pain-related adjunctive
interventions (e.g., physical therapy), as indicated. Participants in TAU only will not
receive behavioral intervention from the primary care clinic behavioral health provider.
We will conduct brief interviews with up to 24 purposefully selected participants (i.e., 12
VA providers and 12 patients). The VA provider group will include 6 primary care providers
and 6 behavioral health providers I providers who staff VA primary care clinics. Interview
items are based on implementation constructs relevant for early stage intervention
development: acceptability (or agreeableness and satisfaction with treatment components),
appropriateness (or perceived fit/compatibility of the intervention), and feasibility (or
whether the intervention is suitable for use.) Up to 12 patients who were randomized to Brief
CBT-CP will be asked to complete a 30-minute interviews (i.e., telephone or face-to-face,
depending on participant preference) following their 12-week assessment (as described in the
consent procedures prior to the trial). We will include participants who completed all study
procedures but will also attempt to include those who discontinued Brief CBT-CP.
Buffalo, NY. Thirty eligible participants will be randomized in a 1:1 ratio into either (1)
Brief CBT-CP plus TAU or (2) TAU only. We will engage in recruitment during the second
quarter of Year 1 through the end of the first quarter of Year 2. We aim to recruit and
enroll 7-8 participants per quarter during that time frame. Post-treatment follow-up will be
conducted at eight weeks and at 12 weeks. Two recruitment methods will be used. Veterans with
chronic musculoskeletal pain who self-report functional impairment will be referred by their
PACT, in response to a recruitment flyer posted in primary care, or by contacting the PI or
study staff directly after hearing of the study by word of mouth or other sources. This
approach will be supplemented by a case-finding procedure in which study staff review
electronic medical record data to identify potential patients, who will be subsequently
contacted by letter and screened by telephone. Following telephone screening, potentially
eligible participants will complete a baseline assessment to assess pain and related
characteristics as well as remaining exclusion criteria. Those passing baseline measures will
be randomized to (1) Brief CBT-CP plus TAU or (2) TAU only. Assignment to Brief CBT-CP will
be stratified based on degree of pain interference.
Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course
of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix.
Session one focuses on foundational pain education and the development of treatment goals.
Session two emphasizes balanced engagement in physical activity and pleasurable events.
Session three emphasizes skills training for easily implemented relaxation techniques.
Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively
impact pain. Session six focuses on relapse prevention and independent implementation of
CBT-CP skills following treatment. Brief CBT-CP will be delivered by a masters-level
interventionist either at the Buffalo VA Medical Center or by telephone depending on the
preference of the participant.
Participants assigned to TAU only will receive standard medical care from their primary care
provider including pain medications, brief advice (e.g., use of relative rest, application of
heat or ice, other self-care strategies), or referral to pain-related adjunctive
interventions (e.g., physical therapy), as indicated. Participants in TAU only will not
receive behavioral intervention from the primary care clinic behavioral health provider.
We will conduct brief interviews with up to 24 purposefully selected participants (i.e., 12
VA providers and 12 patients). The VA provider group will include 6 primary care providers
and 6 behavioral health providers I providers who staff VA primary care clinics. Interview
items are based on implementation constructs relevant for early stage intervention
development: acceptability (or agreeableness and satisfaction with treatment components),
appropriateness (or perceived fit/compatibility of the intervention), and feasibility (or
whether the intervention is suitable for use.) Up to 12 patients who were randomized to Brief
CBT-CP will be asked to complete a 30-minute interviews (i.e., telephone or face-to-face,
depending on participant preference) following their 12-week assessment (as described in the
consent procedures prior to the trial). We will include participants who completed all study
procedures but will also attempt to include those who discontinued Brief CBT-CP.
Inclusion Criteria:
- A diagnosis of musculoskeletal pain of three months
- Pain-related functional impairment
- If currently prescribed pain or psychiatric medicine, a stable dose in the last three
months (other than OTCs)
- Conversant in English
- Established history of VA primary care utilization (i.e., at least one primary care
visit in the past year)
Exclusion Criteria:
- Current engagement in psychotherapy or behavioral intervention provided by behavioral
medicine services, specialty mental health, or Primary Care Mental Health Integration
services for any indication. Note that medication management through these services is
not excluded.
- Receiving medical treatments (e.g., surgery, injections) known to impact pain-related
outcomes
- Endorsement of imminent suicide risk
- Current substance use problems (i.e., alcohol, opioids, benzodiazepines, or other
drugs)
- Unstable psychiatric status (e.g., active psychosis, current mania)
- Diagnosed with major or minor neurocognitive disorder
- Unwilling to have treatment sessions audio recorded
We found this trial at
1
site
Buffalo, New York 14215
Principal Investigator: Gregory P. Beehler, PhD
Phone: 716-862-7934
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