Treatment, Pain, and Opioids

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05363176
• Other study ID #: SDR 21-018
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: April 30, 2026

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Cognitive-Behavioral Therapy for Treatment Seeking
CBT delivered over the course of 1, ~45 minute sessions delivered via telehealth.
• 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

Locations

Country	Name	City	State
United States	VA Finger Lakes Healthcare System, Canandaigua, NY	Canandaigua	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PROMIS Profile-29	The PROMIS-29 provides a profile of one's health-related quality of life with components including pain interference, physical functioning, sleep disturbance, social functioning, anxiety, fatigue, and depression.	Baseline to 6-months post-treatment
Other	Opioid use	A 17-item measure will be used that assesses the frequency of aberrant drug-related behaviors and other behaviors that are prevalent among pain patients who are using prescription opioids. The rating scale ranges from 0 ("Never") to 4 ("Very Often"), with higher scores indicating greater risk.	Baseline to 6-months post-treatment
Primary	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	Pain Treatment Willingness Scale (PTWS)	Beliefs about psychosocial and other non-pharmacological pain treatments will be assessed using a modified PTWS. The scale consists of seven items assessing respondents' willingness to use opioids or non-pharmacological approaches using a 6-point rating scale. (1 = "not at all willing" to 6 "extremely willing").	Baseline to 6-months post-treatment
Secondary	Medication Beliefs Questionnaire	The MBQ 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").	Baseline to 6-months post-treatment
Secondary	Beck Hopelessness Scale (BHS)	The BHS contains 20 true-false items designed to assess beliefs about the future. Higher scores represents greater hopelessness.	Baseline to 6-months post-treatment
Secondary	Pain Catastrophizing Scale	The PCS is a 13-item measure, with each item rated on a 5-point rating scale (0 = "Not at all" to 4 = "All the time"). Higher scores represent more rumination, magnification, and helplessness over pain.	Baseline to 6-months post-treatment
Secondary	Pain Self-Efficacy Questionnaire (PSEQ)	The PSEQ is an 11-item measure that assesses one's confidence in performing activities while in pain.	Baseline to 6-months post-treatment
Secondary	Tampa Scale for Kinesiophobia-11 (TSK-11)	The TSK-11 is an 11-item measure assessing pain-related fear of movement or injury with higher scores representing greater fear of movement.	Baseline to 6-months post-treatment