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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| University of Pittsburgh | OTHER |
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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 ≥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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benzodiazepine Medication Taper with Cognitive Behavioral Therapy | Experimental | Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benzodiazepine Medication Taper with Cognitive Behavioral Therapy | Other | Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing (led by pharmacist/clinician/psychologist) over a 10-week Trial. |
| 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 |
| Change in Benzodiazepine Use | Patient-reported benzodiazepine medication doses with change measured by % change from baseline dose. | From enrollment to end of intervention at 10 weeks. |
| Change in Sleep Disturbance Scores | PROMIS Sleep Short Form 8b survey. | From enrollment to end of intervention at 10 weeks. |
| Change in Anxiety Scores | PROMIS Anxiety Short Form 8a Survey. | From enrollment to end of intervention at 10 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0 and Immediately after 10 weeks of participation |
| Behavior: Intentions on tapering measured by a 15-point validated scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gloria Yeh, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41840339 | Derived | Anderson TS, Kraemer KM, McCann ML, Wang BX, Lindenberg JH, Yeh GY. Pharmacist-Led Taper with Brief Mindfulness-Informed Cognitive Behavioral Therapy for Benzodiazepine Deprescribing in Older Adults: A Pilot Trial. J Gen Intern Med. 2026 Mar 16:10.1007/s11606-026-10356-z. doi: 10.1007/s11606-026-10356-z. Online ahead of print. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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 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. | 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 | 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. | 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 | Up to 6 months post intervention |
| D001523 |
| Mental Disorders |