Musculoskeletal Pain, Pain
Conditions
Keywords
primary care, chronic pain, cognitive behavioral therapy, integrated primary care, musculoskeletal pain
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.
Interventions
BEHAVIORALBrief CBT for Chronic Pain
Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks. 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.
OTHERTreatment as usual
Participants assigned to TAU 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Only the outcomes assessor will be masked
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory -- Interference Subscale (BPI-I) to Assess 12 Week Follow-up | 12-weeks | This measure is a validated 7-item subscale that evaluates pain-related interference in daily activities and social and occupational functioning. Average scores range from 0 to 10, with higher scores indicating higher pain-related interference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory -- Pain Intensity Subscale (BPI-P) to Assess 12 Week Follow-up | 12-weeks | This measure is a validated 4-item subscale that evaluates pain intensity. Average scores range from 0 to 10, with higher scores indicating worse pain intensity. |
| Patient Health Questionnaire -- 9 (PHQ-9) to Assess 12 Week Follow-up | 12-weeks | This 9-item measure of depressive symptoms is validated for use in primary care. Total scores range from 0 to 27, with higher scores indicating more depression symptoms. |
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Physical Health at 12 Week Follow up | 12-weeks | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. |
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Psychological Quality of Life at 12 Week Follow up | 12-weeks | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. |
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Social Relationships at 12 Week Follow up | 12-weeks | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. |
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Environmental Health at 12 Week Follow up | 12-weeks | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. |
| Ability to Participate in Social Roles and Activities - Short Form (APSRA) to Assess 12 Week Follow up | 12-weeks | This 8-item measure was developed to evaluate one's perceived ability to perform usual social roles and activities. Total scores range from eight to 40, with higher scores indicating better ability to participate in usual activities. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGregory P. Beehler, PhD
VA Western New York Healthcare System, Buffalo, NY
Baseline characteristics
| Characteristic | — |
|---|---|
| Ability to Participate in Social Roles and Activities - short form (APSRA) | 27.0 Score on a measure STANDARD_DEVIATION 6.1 |
| Age, Continuous | 57.8 years STANDARD_DEVIATION 13.2 |
| Brief Pain Inventory -- Interference subscale (BPI-I) | 6.0 score on a measure STANDARD_DEVIATION 1.5 |
| Brief Pain Inventory -- Pain Intensity subscale (BPI-P) | 5.6 score on a measure STANDARD_DEVIATION 1.4 |
| Patient Health Questionnaire -- 9 (PHQ-9) | 8.5 score on a measure STANDARD_DEVIATION 5.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) White | 142 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 77 Participants |
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess environmental quality of li | 15.9 score on a measure STANDARD_DEVIATION 2.2 |
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess physical quality of life | 11.9 score on a measure STANDARD_DEVIATION 2.7 |
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess psychological health | 14.8 score on measure STANDARD_DEVIATION 2.5 |
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess social quality of life | 14.0 score on a measure STANDARD_DEVIATION 2.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 92 |
| other Total, other adverse events | 12 / 92 | 10 / 92 |
| serious Total, serious adverse events | 2 / 92 | 4 / 92 |
Outcome results
None listed