Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing (CSTARS)

February 2, 2026 updated by: Gloria Y. Yeh, Beth Israel Deaconess Medical Center

Pilot of a Brief Cognitive Behavioral Therapy Intervention to Enhance Benzodiazepine Deprescribing in Older Adults

The goal of this clinical trial is to conduct a single-arm pilot trial of a brief cognitive-behavioral therapy-enhanced benzodiazepine deprescribing intervention in 20 older adults (aged ≥55 years) prescribed chronic benzodiazepines by their primary care clinicians.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Nearly 10% of Americans aged 55 years and older fill benzodiazepine (BZD) prescriptions annually. Chronic use of BZD place older adults at an increased risk of falls, cognitive impairment, functional decline, preventable hospitalizations, and mortality.

Research study investigators will conduct a single-arm pilot trial of the intervention in 20 adults aged 55 and older currently taking chronic BZDs. The aim is to evaluate feasibility/acceptability of the refined deprescribing intervention using mixed methods. At intervention end, research study investigators will conduct surveys and qualitative interviews with participants to obtain feedback on participant experience and intervention components (e.g., acceptability, usefulness, relevance, satisfaction) as well as views on future format options. Using these data and the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework, research study investigators will further refine the intervention in preparation for larger scale testing and implementation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Prescribed chronic benzodiazepines by their primary care clinicians at a Beth Israel Deaconess Medical Center (BIDMC) Primary Care Clinic.

Exclusion Criteria:

  • Primary Care Practitioner (PCP) opt out
  • Severe anxiety or depression symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Benzodiazepine Medication Taper with Cognitive Behavioral Therapy
Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing
Other: Benzodiazepine Medication Taper with Cognitive Behavioral Therapy
Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing (led by pharmacist/clinician/psychologist) over a 10-week Trial.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility: Retention
Time Frame: Immediately after 10 weeks of participation
Recruitment, retention (<10% dropout)
Immediately after 10 weeks of participation
Feasibility: Intervention adherence
Time Frame: Immediately after 10 weeks of participation
Intervention adherence (>75% in at least 2 of 3 sessions)
Immediately after 10 weeks of participation
Acceptability: Open-ended qualitative interview
Time Frame: Immediately after 10 weeks of participation
Usefulness in supporting tapering process, use of specific skills and mindfulness techniques, clarity/length of sessions, helpfulness, plans to continue, suggestions for improvements, alternative session formats using open-ended qualitative interview.
Immediately after 10 weeks of participation
Change in Benzodiazepine Use
Time Frame: From enrollment to end of intervention at 10 weeks.
Patient-reported benzodiazepine medication doses with change measured by % change from baseline dose.
From enrollment to end of intervention at 10 weeks.
Change in Sleep Disturbance Scores
Time Frame: From enrollment to end of intervention at 10 weeks.
PROMIS Sleep Short Form 8b survey.
From enrollment to end of intervention at 10 weeks.
Change in Anxiety Scores
Time Frame: From enrollment to end of intervention at 10 weeks.
PROMIS Anxiety Short Form 8a Survey.
From enrollment to end of intervention at 10 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behavior: Self-efficacy measured by 7-point Likert scale questions
Time Frame: Week 0 and Immediately after 10 weeks of participation
7-point Likert scale questions: I am confident I can: reduce my benzodiazepine dose; manage anxiety and/or insomnia without medications.
Week 0 and Immediately after 10 weeks of participation
Behavior: Intentions on tapering measured by a 15-point validated scale
Time Frame: Week 0 and Immediately after 10 weeks of participation
15-point validated measure to assess one's choice predisposition (leaning) towards an option: In the future I will avoid benzodiazepine medications for sleep/anxiety (1=no, 8=unsure, 15=yes)
Week 0 and Immediately after 10 weeks of participation
Behavior: Attitudes on benzodiazepine use measured by 7-point Likert scale
Time Frame: Week 0 and Immediately after 10 weeks of participation
7-point Likert scale: Reducing benzodiazepine use is: necessary-unnecessary; beneficial-harmful; high-priority-low-priority; worthless-useful.
Week 0 and Immediately after 10 weeks of participation
Behavior: Knowledge on benzodiazepine risk/benefits measured by true/false questions
Time Frame: Week 0 and Immediately after 10 weeks of participation
Knowledge on benzodiazepine risks/benefits will be assessed with 8 True/False questions
Week 0 and Immediately after 10 weeks of participation
Behavior: Norms of using benzodiazapine medications measured by 7-point Likert Scale
Time Frame: Week 0 and Immediately after 10 weeks of participation
Using benzodiazepines for sleep/anxiety: risky-safe; beneficial-harmful; pleasant-unpleasant; My doctor/family think(s) I should use benzodiazepines. There are effective treatments for sleep/anxiety other than medications.
Week 0 and Immediately after 10 weeks of participation
Sustainability of Intervention Effect measured by electronic health record review
Time Frame: Up to 6 months post intervention
Sustainability of benzodiazepine dose reduction, identified by electronic health record review at 3 and 6 months following tapering program completion
Up to 6 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beth Israel Deaconess Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pittsburgh
University of California, San Francisco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gloria Yeh, MD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023P000382

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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