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Clinical Trials/NCT05363176
NCT05363176
Completed
Not Applicable

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

VA Office of Research and Development1 site in 1 country300 target enrollmentJune 1, 2022
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
VA Office of Research and Development
Enrollment
300
Locations
1
Primary Endpoint
Medical Record Review and Treatment Utilization Form
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
March 25, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Medical Record Review and Treatment Utilization Form

Time Frame: Baseline to 6-months post-treatment

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.

Secondary Outcomes

  • Medication Beliefs Questionnaire(Baseline to 6-months post-treatment)
  • Tampa Scale for Kinesiophobia-11 (TSK-11)(Baseline to 6-months post-treatment)
  • Pain Treatment Willingness Scale (PTWS)(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)

Study Sites (1)

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