VA Finger Lakes Healthcare System, Canandaigua, NY
Canandaigua, New York, 14424-1159, United States
NCT Number: NCT05363176
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Canandaigua, New York, 14424-1159, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CBT delivered over the course of 1, ~45 minute sessions delivered via telehealth.
Other names: CBT-TS
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
Time frame: 6-months post-treatment
This will capture treatment initiation (attending at least one appointment). Treatment includes non-pharmacological pain treatments (e.g., psychosocial interventions, movement-related interventions.) This was captured through medical record chart review. The investigators calculated percent who initiated treatment by the 6 month follow-up.
Time frame: 6-months post-treatment
Beliefs about psychosocial and other non-pharmacological pain treatments will be assessed using a modified PTWS, a 7-item scale to assess willingness to try various pain treatments. Scores range from 0 to 6 (averaged across items) with 6 indicating greater willingness to engage in the treatment.
Time frame: 6-months post-treatment
The Medication Beliefs Questionnaire 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"). Scores range from 0 to 20 with higher scores indicating greater endorsement of beliefs.
Time frame: 6-months post-treatment
The Beck Hopelessness Scale contains 20 true-false items designed to assess beliefs about the future. Scores range from 0-20. Higher scores represents greater hopelessness.
Time frame: 6-months post-treatment
The PCS is a 13-item measure, with each item rated on a 5-point rating scale to assess pain catastrophizing. Scores range from 0 to 52 with higher scores indicating higher pain catastrophizing.
Time frame: 6-months post-treatment
The TSK-11 is an 17-item measure assessing pain-related fear of movement or injury. Scores range from 17 to 68 with higher scores indicating greater kinesiophobia.
Time frame: 6-months post-treatment
The PROMIS-29 provides a profile of one's health-related quality of life, in various life domains, including pain interference. Scores range from 4 to 20 with higher scores are indicative of higher pain interference.
VA Office of Research and Development
Fed
Telehealth CBT to Increase Engagement in Pain Treatment Among Veterans Using Prescription Opioids
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