← Back to Search

Behavioural Intervention

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence

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

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

+1 more

Secondary outcome measures

Anxiety Sensitivity Index-3 (change)

California prescription drug monitoring database (CURES)

Pain Catastrophizing Scale (change)

+1 more

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,532 Previous Clinical Trials

10,265,214 Total Patients Enrolled

31 Trials studying Anxiety Disorders

3,649 Patients Enrolled for Anxiety Disorders

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,676 Total Patients Enrolled

12 Trials studying Anxiety Disorders

1,050 Patients Enrolled for Anxiety Disorders

Boston UniversityOTHER

454 Previous Clinical Trials

9,941,516 Total Patients Enrolled

9 Trials studying Anxiety Disorders

2,309 Patients Enrolled for Anxiety Disorders

Media Library

Anxiety Disorders Research Study Groups: Cognitive behavioral therapy for anxiety plus benzodiazepine taper, Health education control plus benzodiazepine taper

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age of consent for this trial set at 18 or lower?

"This clinical trial permits adults aged 18-85 to register as participants, in accordance with the eligibility requirements."

Answered by AI

Are there open slots available for individuals interested in participating in this clinical trial?

"A review of clinicaltrials.gov reveals that this experiment is actively recruiting participants, with the initial posting occurring on February 1st 2023 and the most recent update taking place April 28th 2023."

Answered by AI

How many participants are included in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial is presently recruiting patients, having first been posted on February 1st 2023 and most recently updated April 28th of the same year. 54 individuals are required from a single medical facility."

Answered by AI

What are the primary objectives of this clinical experiment?

"This assessment period, which covers Baseline to two months post-treatment (week 15), is designed to measure patient satisfaction via the Treatment Satisfaction Questionnaire. Secondary assessments include opioid and benzodiazepine prescriptions as corroborated by CURES data, cognitive misappraisals of anxiety through ASI-3 measurements, and Pain Catastrophizing Scale scores that will help assess possible mediation outcomes associated with treatment."

Answered by AI

Are my qualifications compatible with the requirements for this research experiment?

"This trial seeks 54 individuals between 18-85 years old, suffering from anxiety and taking benzodiazepines for at least 3 months. Additionally, they must have a positive urine drug screening result during the baseline assessment; score 8 or higher on the OASIS questionnaire; be prescribed opioids for pain management with a conforming UDS test; possess fluency in English; access to digital devices connected to the internet for telehealth visits; and an agreement to reduce their BZ usage."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Benzodiazepine Taper With Cognitive Behavioral Therapy in Patients Using Prescription Opioids

Kate Taylor 2023. "Benzodiazepine Taper With Cognitive Behavioral Therapy in Patients Using Prescription Opioids". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05573906.

All > Anxiety Disorder