Pilot of a Brief Cognitive Behavioral Therapy Intervention to Enhance Benzodiazepine Deprescribing in Older Adults
Overview
- Phase
- N/A
- Intervention
- Benzodiazepine Medication Taper with Cognitive Behavioral Therapy
- Conditions
- Benzodiazepine Use
- Sponsor
- Beth Israel Deaconess Medical Center
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Feasibility: Retention
- Status
- Completed
- Last Updated
- 2 months ago
Overview
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.
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.
Investigators
Gloria Y. Yeh
Associate Professor of Medicine
Beth Israel Deaconess Medical Center
Eligibility Criteria
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
Arms & Interventions
Benzodiazepine Medication Taper with Cognitive Behavioral Therapy
Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing
Intervention: Benzodiazepine Medication Taper with Cognitive Behavioral Therapy
Outcomes
Primary Outcomes
Feasibility: Retention
Time Frame: Immediately after 10 weeks of participation
Recruitment, retention (\<10% dropout)
Feasibility: Intervention adherence
Time Frame: Immediately after 10 weeks of participation
Intervention adherence (\>75% in at least 2 of 3 sessions)
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.
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.
Change in Sleep Disturbance Scores
Time Frame: From enrollment to end of intervention at 10 weeks.
PROMIS Sleep Short Form 8b survey.
Change in Anxiety Scores
Time Frame: From enrollment to end of intervention at 10 weeks.
PROMIS Anxiety Short Form 8a Survey.
Secondary Outcomes
- 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)
- Sustainability of Intervention Effect measured by electronic health record review(Up to 6 months post intervention)