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Treatment, Pain, and Opioids

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05363176
Enrollment
300
Registered
2022-05-05
Start date
2022-06-01
Completion date
2025-03-25
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Chronic pain, Prescription opioids, Treatment, Treatment engagement, Beliefs

Brief 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. 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.

Interventions

BEHAVIORALCognitive-Behavioral Therapy for Treatment Seeking

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

BEHAVIORALPain treatment education

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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The outcomes assessors will not know what condition that the participant was allocated to, nor will the statistician who is one of the co-investigators.

Intervention model description

Participants are randomized to one of two interventions.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Medical Record Review and Treatment Utilization Form6-months post-treatmentThis 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.

Secondary

MeasureTime frameDescription
Pain Treatment Willingness Scale (PTWS)6-months post-treatmentBeliefs 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.
Medication Beliefs Questionnaire6-months post-treatmentThe 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.
Beck Hopelessness Scale (BHS)6-months post-treatmentThe 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.
Pain Catastrophizing Scale (PCS)6-months post-treatmentThe 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.
Tampa Scale for Kinesiophobia-17 (TSK-17)6-months post-treatmentThe 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLisham Ashrafioun, PhD

VA Finger Lakes Healthcare System, Canandaigua, NY

Baseline characteristics

Characteristic
Age, Continuous63.97 Years
STANDARD_DEVIATION 10.24
Beck Hopelessness Scale5.04 Units on a scale
STANDARD_DEVIATION 4.79
Ethnicity (NIH/OMB)
Hispanic or Latino
19 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
135 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Medication Beliefs Questionnaire16.49 Units on a scale
STANDARD_DEVIATION 2.86
Pain Catastrophizing Scale22.39 Units on a scale
STANDARD_DEVIATION 12.44
Pain Treatment Willingness Scale3.59 Units on a scale
STANDARD_DEVIATION 1.12
PROMIS Pain interference15.61 units on scale
STANDARD_DEVIATION 3.68
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
51 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants
Race (NIH/OMB)
White
168 Participants
Sex: Female, Male
Female
21 Participants
Sex: Female, Male
Male
124 Participants
Tampa Scale of Kinesiophobia30.52 Units on a scale
STANDARD_DEVIATION 5.79

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 1510 / 149
other
Total, other adverse events
28 / 15128 / 149
serious
Total, serious adverse events
10 / 15112 / 149

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026