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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| CBT for Treatment Seeking | Experimental | CBT delivered over the course of 1, ~45 minute session delivered via telehealth. Receives: Behavioral: Cognitive-Behavioral Therapy for Treatment Seeking |
| Pain Treatment Education | Active comparator | Pain 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.
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)
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
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
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
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
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.
- First posted5 May 2022
- Study start1 Jun 2022
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lisham Ashrafioun, PhD, Principal investigator, VA Finger Lakes Healthcare System, Canandaigua, NY
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth CBT to Increase Engagement in Pain Treatment Among Veterans Using Prescription Opioids
- ClinicalTrials.gov ID
- NCT05363176
- Acronym / sponsor ID
- SDR 21-018
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Prescription opioids, Treatment, Treatment engagement, Beliefs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Posted 29 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized to one of two interventions.
| Arm | Type | Receives |
|---|---|---|
| CBT for Treatment Seeking | Experimental | Behavioral: Cognitive-Behavioral Therapy for Treatment SeekingCBT delivered over the course of 1, ~45 minute session delivered via telehealth. |
| Pain Treatment Education | Active comparator | Behavioral: Pain treatment educationPain treatment education is delivered over the course of 1, ~45 minute session delivered via telehealth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral Therapy for Treatment SeekingAlso: CBT-TSCBT delivered over the course of 1, ~45 minute sessions delivered via telehealth. | Behavioural | CBT for Treatment Seeking |
| Pain treatment educationPain 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 | Behavioural | Pain Treatment Education |
Primary outcome
Medical Record Review and Treatment Utilization Form
Time frame: 6-months post-treatment
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.
5 secondary outcomes
Pain Treatment Willingness Scale (PTWS)
Time frame: 6-months post-treatment
Medication Beliefs Questionnaire
Time frame: 6-months post-treatment
Beck Hopelessness Scale (BHS)
Time frame: 6-months post-treatment
Pain Catastrophizing Scale (PCS)
Time frame: 6-months post-treatment
Tampa Scale for Kinesiophobia-17 (TSK-17)
Time frame: 6-months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisham Ashrafioun, PhD principal investigator
VA Finger Lakes Healthcare System, Canandaigua, NY
1 site in 1 country: see every site and its status.
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.