NCT06119308

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

November 8, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2025

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

October 27, 2023

Last Update Submit

February 2, 2026

Conditions

Benzodiazepine UseInsomniaAnxiety

Outcome Measures

Primary Outcomes (6)

  • Feasibility: Retention

    Recruitment, retention (\<10% dropout)

    Immediately after 10 weeks of participation

  • Feasibility: Intervention adherence

    Intervention adherence (\>75% in at least 2 of 3 sessions)

    Immediately after 10 weeks of participation

  • Acceptability: Open-ended qualitative interview

    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

    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

    PROMIS Sleep Short Form 8b survey.

    From enrollment to end of intervention at 10 weeks.

  • Change in Anxiety Scores

    PROMIS Anxiety Short Form 8a Survey.

    From enrollment to end of intervention at 10 weeks.

Secondary Outcomes (6)

  • Behavior: Self-efficacy measured by 7-point Likert scale questions

    Week 0 and Immediately after 10 weeks of participation

  • Behavior: Intentions on tapering measured by a 15-point validated scale

    Week 0 and Immediately after 10 weeks of participation

  • Behavior: Attitudes on benzodiazepine use measured by 7-point Likert scale

    Week 0 and Immediately after 10 weeks of participation

  • Behavior: Knowledge on benzodiazepine risk/benefits measured by true/false questions

    Week 0 and Immediately after 10 weeks of participation

  • Behavior: Norms of using benzodiazapine medications measured by 7-point Likert Scale

    Week 0 and Immediately after 10 weeks of participation

  • +1 more secondary outcomes

Study Arms (1)

Benzodiazepine Medication Taper with Cognitive Behavioral Therapy

EXPERIMENTAL

Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing

Other: Benzodiazepine Medication Taper with Cognitive Behavioral Therapy

Interventions

Benzodiazepine Medication Taper with Cognitive Behavioral TherapyOTHER

Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing (led by pharmacist/clinician/psychologist) over a 10-week Trial.

Benzodiazepine Medication Taper with Cognitive Behavioral Therapy

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Anderson TS, Kraemer KM, McCann ML, Wang BX, Lindenberg JH, Yeh GY. Pharmacist-Led Taper with Brief Mindfulness-Informed Cognitive Behavioral Therapy for Benzodiazepine Deprescribing in Older Adults: A Pilot Trial. J Gen Intern Med. 2026 Mar 16. doi: 10.1007/s11606-026-10356-z. Online ahead of print.

    PMID: 41840339DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersAnxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Gloria Yeh, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 7, 2023

Study Start

November 8, 2023

Primary Completion

October 30, 2024

Study Completion

June 8, 2025

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations

US(1)