Treatment, Pain, and Opioids

NCT05363176 | Completed

• 1 other identifier: SDR 21-018
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic pain; Prescription opioids; Treatment; Treatment engagement; Beliefs

Outcome Measures

Primary Outcomes (1)

• Medical Record Review and Treatment Utilization Form

  This will capture treatment initiation and treatment retention information including treatment types, dates of service, number of sessions, and type and dose of VHA and non-VHA medications dispensed.

  Baseline to 6-months post-treatment

Secondary Outcomes (6)

• Pain Treatment Willingness Scale (PTWS)

  Baseline to 6-months post-treatment

• Medication Beliefs Questionnaire

  Baseline to 6-months post-treatment

• Beck Hopelessness Scale (BHS)

  Baseline to 6-months post-treatment

• Pain Catastrophizing Scale

  Baseline to 6-months post-treatment

• Pain Self-Efficacy Questionnaire (PSEQ)

  Baseline to 6-months post-treatment

Other Outcomes (2)

• PROMIS Profile-29

  Baseline to 6-months post-treatment

• Opioid use

  Baseline to 6-months post-treatment

Study Arms (2)

CBT for Treatment Seeking

EXPERIMENTAL

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

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

Behavioral: Pain treatment education

Interventions

Cognitive-Behavioral Therapy for Treatment Seeking BEHAVIORAL

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

Also known as: CBT-TS

CBT for Treatment Seeking

Pain treatment education 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

Pain Treatment Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Finger Lakes Healthcare System, Canandaigua, NY

Canandaigua, New York, 14424-1159, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lisham Ashrafioun, PhD

  VA Finger Lakes Healthcare System, Canandaigua, NY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants are randomized to one of two interventions.

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: June 1, 2022
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)