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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing (led by pharmacist/clinician/psychologist) over a 10-week Trial.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Feasibility: Retention
Recruitment, retention (\<10% dropout)
Time frame: Immediately after 10 weeks of participation
Feasibility: Intervention adherence
Intervention adherence (\>75% in at least 2 of 3 sessions)
Time frame: 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.
Time frame: Immediately after 10 weeks of participation
Change in Benzodiazepine Use
Patient-reported benzodiazepine medication doses with change measured by % change from baseline dose.
Time frame: From enrollment to end of intervention at 10 weeks.
Change in Sleep Disturbance Scores
PROMIS Sleep Short Form 8b survey.
Time frame: From enrollment to end of intervention at 10 weeks.
Change in Anxiety Scores
PROMIS Anxiety Short Form 8a Survey.
Time frame: From enrollment to end of intervention at 10 weeks.
Behavior: Self-efficacy measured by 7-point Likert scale questions
7-point Likert scale questions: I am confident I can: reduce my benzodiazepine dose; manage anxiety and/or insomnia without medications.
Time frame: Week 0 and Immediately after 10 weeks of participation
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Behavior: Intentions on tapering measured by a 15-point validated scale
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)
Time frame: Week 0 and Immediately after 10 weeks of participation
Behavior: Attitudes on benzodiazepine use measured by 7-point Likert scale
7-point Likert scale: Reducing benzodiazepine use is: necessary-unnecessary; beneficial-harmful; high-priority-low-priority; worthless-useful.
Time frame: Week 0 and Immediately after 10 weeks of participation
Behavior: Knowledge on benzodiazepine risk/benefits measured by true/false questions
Knowledge on benzodiazepine risks/benefits will be assessed with 8 True/False questions
Time frame: Week 0 and Immediately after 10 weeks of participation
Behavior: Norms of using benzodiazapine medications measured by 7-point Likert Scale
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.
Time frame: Week 0 and Immediately after 10 weeks of participation
Sustainability of Intervention Effect measured by electronic health record review
Sustainability of benzodiazepine dose reduction, identified by electronic health record review at 3 and 6 months following tapering program completion
Time frame: Up to 6 months post intervention