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Completed

NCT Number: NCT06119308

Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing

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.

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Key information

Conditions

Benzodiazepine Use Anxiety Anxiety Disorders Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benzodiazepine Medication Taper with Cognitive Behavioral Therapy

Other

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

Primary outcomes

  1. Feasibility: Retention

    Time frame: Immediately after 10 weeks of participation

    Recruitment, retention (<10% dropout)

  2. Feasibility: Intervention adherence

    Time frame: Immediately after 10 weeks of participation

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

  3. 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.

  4. 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.

  5. Change in Sleep Disturbance Scores

    Time frame: From enrollment to end of intervention at 10 weeks.

    PROMIS Sleep Short Form 8b survey.

  6. Change in Anxiety Scores

    Time frame: From enrollment to end of intervention at 10 weeks.

    PROMIS Anxiety Short Form 8a Survey.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • University of California, San Francisco
  • University of Pittsburgh

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Nov 7, 2023
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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