Treatment, Pain, and Opioids

NCT ID: NCT05363176

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-03-25

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CBT for Treatment Seeking

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

Group Type: EXPERIMENTAL

Cognitive-Behavioral Therapy for Treatment Seeking

Intervention Type: BEHAVIORAL

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

Pain Treatment Education

Pain treatment education is delivered over the course of 1, \~45 minute session delivered via telehealth

Group Type: ACTIVE_COMPARATOR

Pain treatment education

Intervention Type: BEHAVIORAL

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

Interventions

Cognitive-Behavioral Therapy for Treatment Seeking

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

Intervention Type: BEHAVIORAL

Pain 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

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT-TS

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisham Ashrafioun, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Finger Lakes Healthcare System, Canandaigua, NY

Locations

VA Finger Lakes Healthcare System, Canandaigua, NY

Canandaigua, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

SDR 21-018

Identifier Type: -

Identifier Source: org_study_id