Anxiety, Benzodiazepine Use, Insomnia
Conditions
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.
Interventions
OTHERBenzodiazepine Medication Taper with Cognitive Behavioral Therapy
Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing (led by pharmacist/clinician/psychologist) over a 10-week Trial.
Sponsors
Beth Israel Deaconess Medical Center
University of California, San Francisco
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Retention | Immediately after 10 weeks of participation | Recruitment, retention (\<10% dropout) |
| Feasibility: Intervention adherence | Immediately after 10 weeks of participation | Intervention adherence (\>75% in at least 2 of 3 sessions) |
| Acceptability: Open-ended qualitative interview | 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 | 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 | From enrollment to end of intervention at 10 weeks. | PROMIS Sleep Short Form 8b survey. |
| Change in Anxiety Scores | From enrollment to end of intervention at 10 weeks. | PROMIS Anxiety Short Form 8a Survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavior: Self-efficacy measured by 7-point Likert scale questions | 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. |
| Behavior: Intentions on tapering measured by a 15-point validated scale | 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) |
| Behavior: Attitudes on benzodiazepine use measured by 7-point Likert scale | 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. |
| Behavior: Knowledge on benzodiazepine risk/benefits measured by true/false questions | Week 0 and Immediately after 10 weeks of participation | Knowledge on benzodiazepine risks/benefits will be assessed with 8 True/False questions |
| Behavior: Norms of using benzodiazapine medications measured by 7-point Likert Scale | 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. |
| Sustainability of Intervention Effect measured by electronic health record review | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGloria Yeh, MD
Beth Israel Deaconess Medical Center
Outcome results
None listed