Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functioning Among Veterans

Pain Clinical Trial

Official title:

Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functional Outcomes amongPrimary Care Veterans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04724694
• Other study ID #: D3485-R
• Secondary ID: RX003485-01A1
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: Gregory P Beehler, PhD
• Phone: (716) 862-7934
• Email: Gregory.Beehler[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain
• Pain

Intervention

Behavioral:
• Brief 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.

Other:
• Treatment 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.

Locations

Country	Name	City	State
United States	VA Western New York Healthcare System, Buffalo, NY	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Self-Efficacy Questionnaire (PSEQ) to assess role in mediation at 12 week follow up	This validated measure includes 10-items related to pain-related self-efficacy, such as accomplishing goals and becoming more active. Total scores range from 0 to 60, with higher scores indicating greater pain-related self-efficacy.	12-weeks
Other	Pain Catastrophizing Scale (PCS) to assess role in mediation at 12 week follow up	This validated 13-item measure assesses pain-related cognitions such as pain magnification and perceived helplessness. Total scores range from 0 to 52, with higher scores indicating higher levels of negative pain-related thoughts	12-weeks
Primary	Brief Pain Inventory -- Interference subscale (BPI-I) to assess change at 12 week follow-up	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.	Baseline, 12-weeks
Secondary	Brief Pain Inventory -- Pain Intensity subscale (BPI-P) to assess change at 12 week follow-up	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.	Baseline, 12-weeks
Secondary	Patient Health Questionnaire -- 9 (PHQ-9) to assess change at 12 week follow-up	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.	Baseline, 12-weeks
Secondary	Scale for Suicide Ideation (SSI) to assess change at 12 week follow-up	This measure is 21-items and rates current attitudes, behaviors, and plans to commit suicide. Average scores range from 0 to 38, with higher scores indicating higher intensity of suicidal ideation.	Baseline, 12-weeks
Secondary	World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess change at 12 week follow up	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.	Baseline, 12-weeks
Secondary	Ability to Participate in Social Roles and Activities - short form (APSRA) to assess change at 12 week follow up	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.	Baseline, 12-weeks