Brief Cognitive Behavioral Therapy for Chronic Pain

Chronic Pain Clinical Trial

Official title:

RCT of Brief Cognitive Behavioral Therapy for Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490981
• Other study ID #: D2741-P
• Secondary ID: 1I21RX002741-01A
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: February 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) is designed 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 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 protocol and 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 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 care.

Description:

We will recruit 30 Veterans from the primary care clinics located at the Buffalo Veterans Affairs medical center in Buffalo, New York. Thirty eligible participants will be randomized in a 1:1 ratio into either (1) Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) plus treatment as usual (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 primary care team, in response to a recruitment flyer posted in primary care, or by contacting the principal investigator 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 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 providers and 12 patients). The provider group will include 6 primary care providers and 6 behavioral health providers I providers who staff Veterans Affairs 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 1, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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 over-the-counter medicines)

• Conversant in English

• Established history of Veterans Affairs 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

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

Intervention

Other:
• Treatment as usual (TAU)
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.

Behavioral:
• Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP)
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.

Locations

Country	Name	City	State
United States	VA Western New York Healthcare System, Buffalo, New York	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
Primary	West Haven-Yale Multidimensional Pain Inventory - Interference (WHYMPI-I) to Assess Change at Follow up	The WHYMPI-I is a validated 9-item subscale that evaluates pain-related interference in daily activities and social and occupational functioning. Average scores range from 0 to 6, with higher scores indicating higher pain-related interference.	12 weeks
Secondary	Patient Health Questionnaire-9 (PHQ-9) to Assess Change at Follow up	This measure is a 9-item measure of depressive symptoms validated for use in primary care. Total scores range from 0 to 27, with higher scores indicating more depression symptoms.	12 weeks
Secondary	Generalized Anxiety Disorder-7 (GAD-7) to Assess Change at Follow up	This measure is a 7-item measure of anxiety symptoms validated for use in primary care. Total scores range from 0 to 21, with higher scores indicating more anxiety symptoms.	12 weeks
Secondary	Pain Numeric Rating Scale (NRS) to Assess Change at Follow up	This single-item question asks respondents to rate their average level of pain on an 11-point scale (0-10). Higher scores indicate worse pain.	12 weeks
Secondary	Pain Self-Efficacy Questionnaire (PSEQ) to Assess Change at 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
Secondary	Pain Catastrophizing Scale (PCS) to Assess Change at 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
Secondary	World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Change at Follow up	This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains (i.e., physical health, psychological, social relationship, and environment). A total summary score across domains ranges from 24 (minimum) to 120 (maximum), with higher scores indicating greater overall quality of life.	12 weeks
Secondary	Ability to Participate in Social Roles and Activities - Short Form (APSRA) to Assess Change at 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.	12 weeks