Clinical trial NCT05363176: Treatment, Pain, and Opioids
Official title: Telehealth CBT to Increase Engagement in Pain Treatment Among Veterans Using Prescription Opioids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain
Prescription opioids
Treatment
Treatment engagement
Beliefs
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-05-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to one of two interventions.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Medical Record Review and Treatment Utilization Form
timeFrame: Baseline to 6-months post-treatment
Secondary outcomes:
measure: Pain Treatment Willingness Scale (PTWS)
timeFrame: Baseline to 6-months post-treatment
measure: Medication Beliefs Questionnaire
timeFrame: Baseline to 6-months post-treatment
measure: Beck Hopelessness Scale (BHS)
timeFrame: Baseline to 6-months post-treatment
measure: Pain Catastrophizing Scale
timeFrame: Baseline to 6-months post-treatment
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Baseline to 6-months post-treatment
measure: Tampa Scale for Kinesiophobia-11 (TSK-11)
timeFrame: Baseline to 6-months post-treatment
Other outcomes:
measure: PROMIS Profile-29
timeFrame: Baseline to 6-months post-treatment
measure: Opioid use
timeFrame: Baseline to 6-months post-treatment
Locations:
city: Canandaigua
country: United States
facility: VA Finger Lakes Healthcare System, Canandaigua, NY
state: New York
Study officials:
affiliation: VA Finger Lakes Healthcare System, Canandaigua, NY
name: Lisham Ashrafioun, PhD
role: PRINCIPAL_INVESTIGATOR
References: