AzTrials
AzTrials

Chronic PainNCT03490981

Brief Cognitive Behavioral Therapy for Chronic Pain

A study testing Treatment as usual (TAU) and Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) in people with Chronic Pain and Musculoskeletal Pain, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.… Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Chronic Pain, Musculoskeletal Pain
What is being tested?
Treatment as usual (TAU) and Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Oct 2018to 1 May 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Western New York Healthcare System, Buffalo, New York

    Buffalo, New York, 14215

Other trials in United States

About this study

Official title: RCT of Brief Cognitive Behavioral Therapy for Chronic Pain

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.

Read the detailed 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.

Being tested
Treatment as usual (TAU), Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP)
Keywords
primary care, chronic pain, musculoskeletal pain, cognitive behavioral therapy, integrated primary care
Medical subject headings
Chronic Pain, Musculoskeletal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment as usual (TAU)Other

    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.

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

    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.

Study groups in NCT03490981
Study groupRoleWhat they receive
Treatment as usual (TAU) onlyOtherPrimary care treatment as usual
Receives: Other: Treatment as usual (TAU)
Treatment as usual (TAU) plus Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP)ExperimentalPrimary care treatment as usual and Brief CBT-CP
Receives: Behavioral: Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

Secondary outcomes (7)
  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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.

    Measured: 12 weeks

  5. 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.

    Measured: 12 weeks

  6. 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.

    Measured: 12 weeks

  7. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2018
  2. Study start1 Oct 2018
  3. Primary completion20 Jan 2020
  4. Study completion1 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03490981
Sponsor's protocol ID
D2741-P
Other IDs
1I21RX002741-01A1
Status last verified
Feb 2021
First submitted
30 Mar 2018
Last updated
3 Mar 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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 individual participant data (IPD) that underlie results presented in publications.

Publications

  • Conrad M, Kimber JM, Moskal D, Pietropaoli VA, King PR Jr, Beehler GP, Conrad M, Kimber JM, Moskal D, Pietropaoli VA, King PR Jr, Beehler GP. Patient and provider perspectives of Brief Cognitive Behavioral Therapy for Chronic Pain: a qualitative analysis of a pilot randomized controlled trial. Transl Behav Med. 2026 Jan 7;16(1):ibag011. doi: 10.1093/tbm/ibag011.

    PubMed 41981856
  • Beehler G, Funderburk J, King P, Wade M, Goldstein W, Murphy J, Heapy A, Dollar K. Feasibility Outcomes from a Pilot Randomized Controlled Trial of Brief Cognitive Behavioral Therapy for Chronic Pain Among Military Veterans. J Clin Psychol Med Settings. 2026 Jun;33(2):259-269. doi: 10.1007/s10880-026-10148-x. Epub 2026 Apr 6.

    PubMed 41942795

Questions about this trial

What is this clinical trial studying?

A study testing Treatment as usual (TAU) and Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) in people with Chronic Pain and Musculoskeletal Pain, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

West Haven-Yale Multidimensional Pain Inventory - Interference (WHYMPI-I) to Assess Change at Follow up (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03490981, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Brief Cognitive Behavioral Therapy for Chronic Pain | AzTrials