Cognitive Behavioral Therapy + Benzodiazepine Taper for Anxiety

N/A

Recruiting

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, weeks 1-14, post-treatment (week 15), and 2 months from week 15

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to reduce the use of benzodiazepines (BZT) among patients taking opioids. Participants will receive a telehealth intervention of BZT taper + either CBT or health education, with assessments at baseline and 2-month follow-up. If successful, this could reduce major consequences of concurrent opioid/BZT use, incl. mortality.

Who is the study for?

This trial is for adults aged 18-85 who have been taking prescribed benzodiazepines and opioids for at least 3 months, are experiencing significant anxiety (scoring ≥8 on the OASIS), speak English, can access telehealth services, and want to reduce their use of benzodiazepines. Pregnant individuals or those with severe psychiatric symptoms, certain substance use disorders, ongoing need for benzodiazepines due to medical conditions, recent use of other drugs (except limited cannabis), or marked cognitive impairment cannot participate.

What is being tested?

The study tests whether Cognitive Behavioral Therapy (CBT) combined with a gradual reduction in benzodiazepine usage over 12 weeks is more effective than just health education plus tapering off these medications. Participants will receive treatment via telehealth and be monitored throughout the process as well as after completion to assess anxiety symptoms and medication use.

What are the potential side effects?

Potential side effects from reducing benzodiazepine usage include increased anxiety, sleep disturbances, irritability, tremors, sweating, difficulty concentrating, nausea or vomiting. CBT itself has no direct physical side effects but may initially increase distress by confronting anxious thoughts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, weeks 1-14, post-treatment (week 15), and 2 months from week 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, weeks 1-14, post-treatment (week 15), and 2 months from week 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 1-14, post-treatment (week 15), and 2 months from week 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence

Depression Anxiety and Stress Scale (change in scores over time)

Timeline Followback (change in benzodiazepine and opioid use and dose)

+1 more

Secondary study objectives

Anxiety Sensitivity Index-3 (change)

California prescription drug monitoring database (CURES)

Pain Catastrophizing Scale (change)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive behavioral therapy for anxiety plus benzodiazepine taperExperimental Treatment1 Intervention

11 sessions of individual therapy consisting of exposure-based cognitive behavioral therapy that is designed specifically for assisting with benzodiazepine taper. This will be added to a gentle, 12-week benzodiazepine taper. CBT will be initiated for two sessions prior to the benzodiazepine taper initiation.

Group II: Health education control plus benzodiazepine taperActive Control1 Intervention

11 sessions of individual therapy control consisting of psychoeducational topics related to health and well-being, along with the gentle, 12-week benzodiazepine taper.

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