Cognitive Behavioral Therapy for Chronic Pain

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byLisham Ashrafioun, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lisham Ashrafioun, PhD

Principal Investigator

VA Finger Lakes Healthcare System, Canandaigua, NY

Eligibility Criteria

This trial is for English-speaking Veterans who have been on long-term opioid therapy (over 20mg morphine equivalent daily) for chronic pain, experiencing pain most days over the last six months. They must not be undergoing cancer treatment or hospice care, have no recent/upcoming surgeries, and not currently in non-drug pain treatments.

Inclusion Criteria

I have experienced pain on most days for the last six months.

I am a veteran prescribed opioids equivalent to more than 20mg of morphine daily for over 90 days.

You need to have quite a bit of pain and it must really affect your daily life.

Exclusion Criteria

I am a veteran who has had surgery recently or will soon.

I am a veteran and have been in a non-drug pain treatment program recently.

I am a veteran receiving cancer treatment or in hospice care.

Treatment Details

Interventions

Cognitive-Behavioral Therapy for Treatment Seeking (Cognitive Behavioral Therapy)
Pain treatment education (Behavioral Intervention)

Trial OverviewThe study tests Cognitive-Behavioral Therapy for Treatment Seeking (CBT-TS) against an education control to see if it helps Veterans start and stick with psychological interventions for managing chronic pain, potentially reducing reliance on opioids.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: CBT for Treatment SeekingExperimental Treatment1 Intervention

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

Group II: Pain Treatment EducationActive Control1 Intervention

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