Clinical trial NCT04724694: Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functioning Among Veterans
Official title: Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functional Outcomes Among Primary Care Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Pain
Keywords: primary care
chronic pain
cognitive behavioral therapy
integrated primary care
musculoskeletal pain
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-01-26
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm parallel design: 1) primary care treatment as usual, or 2) primary care treatment as usual and Brief Cognitive Behavioral Therapy for Chronic Pain
Primary purpose: TREATMENT

Brief summary: Chronic pain is very common among primary care Veterans and can seriously impact overall patient functioning and well-being. Currently, behavioral treatments for pain management are not often provided in primary care because they are designed to be delivered in specialty care settings, such as chronic pain clinics. To address this gap in care, the proposed study will test if Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) is an effective treatment. Therefore, the first objective of the proposed study is to conduct a randomized controlled trial of Brief CBT-CP compared to primary care treatment as usual to assess treatment effectiveness by examining changes in pain-related physical activity interference, psychological distress, pain intensity, and other related outcomes. 178 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 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), mid-treatment, post-treatment, and at 6-month follow-up. The second objective of this study is examine the mechanisms by which Brief CBT-CP leads to improvement in patient outcomes. Statistical analysis will reveal if changes pain self-efficacy (i.e., perceived ability to manage pain or engage in usual activities despite being in pain) and catastrophizing (i.e., unhelpful, negative though patterns about pain and pain management) lead to improvements in patient functioning. The third objective of this study will be to explore perceptions of Brief CBT-CP among patients who experience significant improvement in outcomes compared to those who did not experience improvement. Participants will include up to 40 patients who were treated with Brief CBT-CP. Participants will be interviewed about key components of the treatment and their perception of effectiveness. Interview data will be compared to the results of statistical analysis to help understand the mechanisms by which Brief CBT-CP is effective or identify areas for improvement. Results of this study will provide information needed to determine if Brief CBT-CP should be widely disseminated across VA primary care clinics.


Eligibility criteria: Inclusion Criteria:

* Veterans age \>=18 and \<=79 years
* Conversant in English
* A diagnosis of musculoskeletal pain of \>three months
* PEG score of \>= 4 on pain intensity item and both interference items at screening
* BPI interference and pain intensity score of at least 4.0 at baseline
* If currently prescribed pain medication (other than topicals or NSAIDS), a stable dose in the last two months
* If currently prescribed psychiatric medicine, a stable dose in the last two months
* Established history of VA primary care utilization (i.e., at least one primary care visit in the past year)

Exclusion Criteria:

* Current or prior (past 12 months) engagement in psychotherapy or behavioral intervention provided by behavioral medicine services or specialty mental health for chronic pain.

  * Medication management through psychiatric services or an on-going course of mental health services for issues other than chronic pain are not excluded.
* Endorsement of imminent suicide risk
* Current significant 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
* Pending disability claim
* Recent or planned surgical/interventional procedure for pain

Primary outcomes:
measure: Brief Pain Inventory -- Interference subscale (BPI-I) to assess change at 12 week follow-up
timeFrame: Baseline, 12-weeks
Secondary outcomes:
measure: Brief Pain Inventory -- Pain Intensity subscale (BPI-P) to assess change at 12 week follow-up
timeFrame: Baseline, 12-weeks
measure: Patient Health Questionnaire -- 9 (PHQ-9) to assess change at 12 week follow-up
timeFrame: Baseline, 12-weeks
measure: Scale for Suicide Ideation (SSI) to assess change at 12 week follow-up
timeFrame: Baseline, 12-weeks
measure: World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess change at 12 week follow up
timeFrame: Baseline, 12-weeks
measure: Ability to Participate in Social Roles and Activities - short form (APSRA) to assess change at 12 week follow up
timeFrame: Baseline, 12-weeks
Other outcomes:
measure: Pain Self-Efficacy Questionnaire (PSEQ) to assess role in mediation at 12 week follow up
timeFrame: 12-weeks
measure: Pain Catastrophizing Scale (PCS) to assess role in mediation at 12 week follow up
timeFrame: 12-weeks
Locations:
city: Buffalo
country: United States
facility: VA Western New York Healthcare System, Buffalo, NY
state: New York
Study officials:
affiliation: VA Western New York Healthcare System, Buffalo, NY
name: Gregory P. Beehler, PhD
role: PRINCIPAL_INVESTIGATOR
References: