Benzodiazepine Taper With Telehealth-Delivered Cognitive Behavioral Therapy for Patients Using Prescription Opioids

Study Overview
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Brief Summary
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The study aims to examine the efficacy of a telehealth-delivered cognitive behavioral therapy (CBT) + benzodiazepine taper (BZ-TP) program in facilitating reductions in benzodiazepine use among patients who are prescribed opioids for pain.

Detailed Description
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This study will examine the efficacy of adding a cognitive behavioral therapy (CBT) program developed and evaluated for patients with anxiety disorders to a benzodiazepine (BZ) taper as an augmentation strategy to improve the success of benzodiazepine reduction among patients taking concurrent opioid prescriptions for pain. There is a high risk of mortality including fatal overdose among patients taking opioids and BZs, yet it remains a prevalent problem. Treating underlying anxiety contributing to BZ use and potentially implicated in pain has the potential to decrease BZ use and possibly reduce opioid use. Thus, the current study moves the field forward in testing the efficacy of a combined CBT + BZ taper compared to the BZ taper plus a health education control condition. All interventions will be delivered via telehealth to patients recruited from a primary care clinic, where BZ and opioid co-prescribing is common and primary care providers may lack the tools and resources to effectively taper their patients off BZs. Participants who are co-prescribed benzodiazepines and opioids and report elevated anxiety symptoms will be randomized to one of two conditions: (1) BZ taper with telehealth delivered CBT to facilitate taper; (2) BZ taper with health education control. Participants will be assessed on anxiety symptoms, BZ use/dose, opioids use/dose at baseline, post-treatment, and at a 2-month follow-up.

Official Title
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Augmenting the Efficacy of Benzodiazepine Taper With Telehealth-Delivered Cognitive Behavioral Therapy for Anxiety Disorders in Patients Using Prescription Opioids

Conditions
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Substance Use Disorders, Anxiety Disorders, Chronic Pain

Intervention / Treatment
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* Behavioral: Benzodiazepine Taper
* Behavioral: Cognitive Behavioral Therapy (CBT)
* Behavioral: Health Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have been taking prescribed BZs for at least 3 months prior to baseline and have a positive UDS for BZs at baseline; Currently experience significant distress or impairment due to their anxiety symptoms (i.e., score ≥ 8 on the OASIS during screening Have been prescribed opioids for at least 3 months for pain management and have a positive UDS for prescribed opioids at baseline Between 18-85 years old Fluent in English Have access to a digital device with internet access for telehealth. Willing to reduce BZ use. Exclusion Criteria: Pregnancy Psychiatric symptoms requiring a higher level of care (i.e., severe suicidality, manic or psychotic symptoms not stabilized on medication, presence of any SUD other than tobacco use disorder, OUD (co-occurring with pain condition) or sedative/hypnotic use disorder) Medical conditions that require ongoing treatment with benzodiazepines (e.g., certain seizure disorders) Use of drugs other than BZs and opioids in the past 30 days (as indicated by UDS and self-report, with the exception of intermittent cannabis use) Use of alcohol above at-risk drinking cutoffs per US Dietary Guidelines Marked cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT + BZ-TP<br>Participants in this condition will receive telehealth-delivered Cognitive Behavioral Therapy (CBT) in addition to the benzodiazepine taper (BZ-TP) treatment. | Behavioral: Benzodiazepine Taper<br>* The BZ-TP is a 14-week intervention that assists participants in reducing their benzodiazepine prescription through a gradual taper at approximately 10%-20% reduction per week for a total of 12 weeks. Dose reduction will be recommended but not required. This intervention is identical in both arms.<br>Behavioral: Cognitive Behavioral Therapy (CBT)<br>* The telehealth delivered CBT is an 11-week intervention that includes psychoeducation, interoceptive exposure, somatic skills, and cognitive restructuring.<br>|
| Active Comparator: HE + BZ-TP<br>Participants in this condition will receive telehealth-delivered health education in addition to the benzodiazepine taper (BZ-TP) treatment. | Behavioral: Benzodiazepine Taper<br>* The BZ-TP is a 14-week intervention that assists participants in reducing their benzodiazepine prescription through a gradual taper at approximately 10%-20% reduction per week for a total of 12 weeks. Dose reduction will be recommended but not required. This intervention is identical in both arms.<br>Behavioral: Health Education<br>* The Health Education (HE) intervention will include 11 weeks of an interactive health education program to match for therapy time. The HE is a published multimedia program addressing various health, wellness and lifestyle topics such as nutrition, dental care, immunizations, health screening, smoking, and time management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timeline Followback | Assesses for change in benzodiazepine use frequency and dose across study duration | Baseline, Weekly for the duration of treatment (up to 20 weeks), post-treatment (at 20 weeks post baseline), and at 2-month follow-up | 
| Depression, Anxiety, & Stress Scale | Assesses for change in anxiety symptom severity across study duration | Baseline, Weekly for the duration of treatment (up to 20 weeks), post-treatment (at 20 weeks post baseline), and at 2-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Sensitivity Index | Used to assess for change in anxiety sensitivity across the duration of the study as a secondary outcome and potential treatment mediator | Baseline, Bi-weekly for the duration of treatment (up to 20 weeks), post-treatment (at 20 weeks post baseline), and at 2-month follow-up | 
| Pain Catastrophizing Scale | Assesses for change in pain catastrophizing across the duration of the study as a secondary outcome related to opioid use, which will also be examined as a potential mediator of treatment outcome | Baseline, Bi-weekly for the duration of treatment (up to 20 weeks), post-treatment (at 20 weeks post baseline), and at 2-month follow-up | 
| Timeline Followback | Assesses changes in opioid use and dose across study duration | Baseline, Weekly for the duration of treatment (up to 20 weeks), post-treatment (at 20 weeks post baseline), and at 2-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telehealth, Cognitive Behavioral Therapy, Benzodiazepine Taper, Anxiety, Opioids, Pain