Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing (CSTARS)

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: Recruiting
• Conditions: Insomnia; Anxiety; Benzodiazepine Use
• Intervention / Treatment: Other: Benzodiazepine Medication Taper with Cognitive Behavioral Therapy

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: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brianna Wang; Phone Number: 6177541410; Email: bwang8@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Brianna Wang; Email: bwang8@bidmc.harvard.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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
Acceptability: Likert Scale responses	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 Likert scale responses.	Immediately after 10 weeks of participation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior: Self-efficacy	Five 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	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	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	Knowledge on benzodiazepine risks/benefits will be assessed with 8 True/False questions	Week 0 and Immediately after 10 weeks of participation
Behavior: Norms	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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: University of Pittsburgh; University of California, San Francisco
• Investigators: Principal Investigator: Gloria Yeh, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID 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