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Brief Cognitive Behavioral Therapy for Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490981
Recruitment Status : Active, not recruiting
First Posted : April 6, 2018
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Musculoskeletal Pain Other: TAU Behavioral: Brief CBT-CP Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Outcomes Assessor)
Masking Description: Only the outcomes assessor will be masked
Primary Purpose: Treatment
Official Title: RCT of Brief Cognitive Behavioral Therapy for Chronic Pain
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : January 20, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
TAU only
Primary care treatment as usual
Other: 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.

Experimental: TAU plus Brief CBT-CP
Primary care treatment as usual and Brief CBT-CP
Behavioral: 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.




Primary Outcome Measures :
  1. West Haven-Yale Multidimensional Pain Inventory - Interference (WHYMPI-I) to assess change at follow up [ Time Frame: Baseline, 8 weeks, 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9) to assess change at follow up [ Time Frame: Baseline, 8 weeks, 12 weeks ]
    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.

  2. Generalized Anxiety Disorder-7 (GAD-7) to assess change at follow up [ Time Frame: Baseline, 8 weeks, 12 weeks ]
    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.

  3. Pain Numeric Rating Scale (NRS) to assess change at follow up [ Time Frame: Baseline, 8 weeks, 12 weeks ]
    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.

  4. Pain Self-Efficacy Questionnaire (PSEQ) to assess change at follow up [ Time Frame: Baseline, 8 weeks, 12 weeks ]
    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.

  5. Pain Catastrophizing Scale (PCS) to assess change at follow up [ Time Frame: Baseline, 8 weeks, 12 weeks ]
    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.

  6. World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess change at follow up [ Time Frame: Baseline, 8 weeks, 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.

  7. Ability to Participate in Social Roles and Activities - short form (APSRA) to assess change at follow up [ Time Frame: Baseline, 8 weeks, 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490981


Locations
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United States, New York
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, United States, 14215
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Gregory P. Beehler, PhD VA Western New York Healthcare System, Buffalo, NY

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03490981    
Other Study ID Numbers: D2741-P
1I21RX002741-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. The LDS will contain IPD that underlie results presented in publications.
Supporting Materials: Study Protocol
Time Frame: IPD will be made available for up to three years starting six months after final publication.
Access Criteria: Data will be shared upon completion of a written request and within 90 days of a completed Data Use Agreement (DUA).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
primary care
chronic pain
musculoskeletal pain
cognitive behavioral therapy
integrated primary care
Additional relevant MeSH terms:
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Musculoskeletal Pain
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases