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Chronic PainNCT05363176

Treatment, Pain, and Opioids

A study testing Cognitive-Behavioral Therapy for Treatment Seeking and Pain treatment education in people with Chronic 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
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Trial summary

Background: Chronic pain and negative consequences of long-term opioid therapy are related public health concerns associated with significant functional impairment, high psychiatric comorbidity, and premature mortality, particularly among Veterans. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Pain
What is being tested?
Cognitive-Behavioral Therapy for Treatment Seeking and Pain treatment education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
1 Jun 2022to 25 Mar 2025
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants will include English-speaking Veterans on long-term opioid therapy prescribed opioid analgesics (>20mg morphine equivalent daily [MEDD] and at least a 90 days supply).
  • Participants must report pain that occurs on at least half the days for six months.
  • They must score at least a 4 on each item of the three items on a brief pain intensity and interference measure.

Who cannot join

  • Veterans will be excluded if they are currently undergoing oncology treatment, are hospice patients, and have a recent or upcoming surgery.
  • Veterans will be excluded if they are currently engaged (i.e., within the past month) in non-pharmacological pain treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Finger Lakes Healthcare System, Canandaigua, NY

    Canandaigua, New York, 14424-1159

Other trials in United States

About this study

Official title: Telehealth CBT to Increase Engagement in Pain Treatment Among Veterans Using Prescription Opioids

Background: Chronic pain and negative consequences of long-term opioid therapy are related public health concerns associated with significant functional impairment, high psychiatric comorbidity, and premature mortality, particularly among Veterans. Clinical Practice Guidelines for opioid prescribing and pain management recommend using non-pharmacological approaches as first-line treatments. Psychosocial interventions (e.g., cognitive-behavioral therapy) have strong evidence supporting their ability to improve pain outcomes. Patient beliefs about the stigma associated with psychological interventions, opioid analgesics, ability of psychosocial intervention to improve pain among others can greatly interfere with the patients' ability to initiate and maintain engagement in psychosocial interventions and other non-pharmacological approaches.

Significance/Impact: Without a concerted effort at affecting beliefs that impede engagement in treatment, Veterans who may benefit from the treatment, will not receive it. This can result in continued risk for negative consequences associated with long-term opioid therapy and inadequate pain management. Cognitive-Behavioral Therapy for Treatment Seeking (CBT-TS) is an evidence-based intervention that directly intervenes on beliefs that act as barriers to treatment initiation and retention. By intervening on these beliefs, this study has the potential to improve engagement in psychosocial pain interventions and other non-pharmacological pain treatments, which will improve pain-related interference and functioning and reduce reliance on opioid analgesics. This study addresses VHA/VA Veteran care priorities including opioid use, pain management, and access and directly addresses priorities of the HSR\&D Targeted Solicitation for Service Directed Research on Opioid Safety and Opioid Use Disorder.

Read more

Innovation: The proposed study is the first application of CBT-TS for Veterans with chronic pain who are receiving opioid analgesics-a notably high-risk, treatment-resistant population. This is the first study to directly intervene on thoughts about psychosocial interventions.

Specific Aims: The specific aims are to: test the effects of CBT-TS to increase initiation of psychosocial interventions for pain among Veterans receiving opioid analgesics for chronic pain (Aim 1), test the effects of CBT-TS to increase the retention in psychosocial interventions for pain among Veterans receiving opioid analgesics for chronic pain (Aim 2), and evaluate the effects of CBT-TS in improving pain and substance use outcomes among Veterans receiving opioid analgesics for chronic pain (Aim 3). The investigators will also test the effects of CBT-TS on the initiation of and retention to other non-pharmacological pain treatments (Exploratory Aim).

Methodology: Participants (N = 300) will be randomized to either the CBT-TS condition or an education control condition. Participants in both conditions will complete assessments on pain, treatment engagement, and opioid use at baseline, and 1-, 3-, and 6-months post-treatment to assess primary, secondary, and exploratory outcomes.

Implementation/Next Steps: Results from this study will provide critical information on increasing engagement of psychosocial interventions for pain, which can be used to inform future implementation and dissemination efforts. The research team will work with the VHA National Pain Management and Opioid Safety office and the VHA Office of Patient Centered Care \& Cultural Transformation to identify implementation and dissemination efforts. CBT-TS is undergoing current implementation research to increase mental health functioning and this effort could be expanded to also increase treatment engagement of psychosocial interventions for pain and other non-pharmacological pain treatments.

Conditions
Chronic Pain
Being tested
Cognitive-Behavioral Therapy for Treatment Seeking, Pain treatment education
Keywords
Chronic pain, Prescription opioids, Treatment, Treatment engagement, Beliefs
Medical subject headings
Chronic Pain

What participants receive

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

  • Cognitive-Behavioral Therapy for Treatment SeekingBehavioural

    Also called CBT-TS

    CBT delivered over the course of 1, ~45 minute sessions delivered via telehealth.

  • Pain treatment educationBehavioural

    Pain treatment education describes a variety of pain treatments offered in the VA. It is delivered over the course of 1, ~45 minute session delivered via telehealth

Study groups in NCT05363176
Study groupRoleWhat they receive
CBT for Treatment SeekingExperimentalCBT delivered over the course of 1, ~45 minute session delivered via telehealth.
Receives: Behavioral: Cognitive-Behavioral Therapy for Treatment Seeking
Pain Treatment EducationActive comparatorPain treatment education is delivered over the course of 1, ~45 minute session delivered via telehealth
Receives: Behavioral: Pain treatment education

What is being measured

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

  1. Medical Record Review and Treatment Utilization Form

    This will capture treatment initiation (attending at least one appointment). Treatment includes non-pharmacological pain treatments (e.g., psychosocial interventions, movement-related interventions.) This was captured through medical record chart review. The investigators calculated percent who initiated treatment by the 6 month follow-up.

    Measured: 6-months post-treatment

Secondary outcomes (5)
  1. Pain Treatment Willingness Scale (PTWS)

    Beliefs about psychosocial and other non-pharmacological pain treatments will be assessed using a modified PTWS, a 7-item scale to assess willingness to try various pain treatments. Scores range from 0 to 6 (averaged across items) with 6 indicating greater willingness to engage in the treatment.

    Measured: 6-months post-treatment

  2. Medication Beliefs Questionnaire

    The Medication Beliefs Questionnaire uses five items to assess beliefs about one's response to, relief from, and potential for addiction to opioid analgesics. Respondents are asked to select one of five responses for each item (e.g., "None at all" to "Complete", "Much worse" to "Much better"). Scores range from 0 to 20 with higher scores indicating greater endorsement of beliefs.

    Measured: 6-months post-treatment

  3. Beck Hopelessness Scale (BHS)

    The Beck Hopelessness Scale contains 20 true-false items designed to assess beliefs about the future. Scores range from 0-20. Higher scores represents greater hopelessness.

    Measured: 6-months post-treatment

  4. Pain Catastrophizing Scale (PCS)

    The PCS is a 13-item measure, with each item rated on a 5-point rating scale to assess pain catastrophizing. Scores range from 0 to 52 with higher scores indicating higher pain catastrophizing.

    Measured: 6-months post-treatment

  5. Tampa Scale for Kinesiophobia-17 (TSK-17)

    The TSK-11 is an 17-item measure assessing pain-related fear of movement or injury. Scores range from 17 to 68 with higher scores indicating greater kinesiophobia.

    Measured: 6-months post-treatment

Timeline

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

  1. First posted5 May 2022
  2. Study start1 Jun 2022
  3. Primary completion25 Mar 2025
  4. Study completion25 Mar 2025

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
Participants are randomized to one of two interventions.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05363176
Sponsor's protocol ID
SDR 21-018
Status last verified
May 2026
First submitted
2 May 2022
Last updated
29 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive-Behavioral Therapy for Treatment Seeking and Pain treatment education in people with Chronic 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 3 inclusion and 2 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 29 May 2026. 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 29 May 2026). 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?

Medical Record Review and Treatment Utilization Form (time frame: 6-months post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 May 2026.

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