Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing

Study Overview
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Brief Summary
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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 ≥65 years) prescribed chronic benzodiazepines by their primary care clinicians.

Detailed Description
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Nearly 10% of Americans aged 65 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 65 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.

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

Conditions
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Anxiety, Benzodiazepine Use, Insomnia

Intervention / Treatment
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* Other: Benzodiazepine Medication Taper with Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prescribed chronic benzodiazepines by their primary care clinicians at Beth Israel Deaconess Medical Center (BIDMC) Healthcare Associates Clinic Exclusion Criteria: Primary Care Practitioner (PCP) opt out Severe anxiety or depression symptoms

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Benzodiazepine Medication Taper with Cognitive Behavioral Therapy<br>Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing | Other: Benzodiazepine Medication Taper with Cognitive Behavioral Therapy<br>* Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing (led by pharmacist/clinician/psychologist) over a 10-week Trial.<br>|

What is the study measuring?
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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 |