Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119308
• Other study ID #: 2023P000382
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: June 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Brianna Wang
• Phone: 6177541410
• Email: bwang8[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Insomnia

Intervention

Other:
• Benzodiazepine Medication Taper with Cognitive Behavioral Therapy
Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing (led by pharmacist/clinician/psychologist) over a 10-week Trial.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	University of California, San Francisco, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Retention	Recruitment, retention (<10% dropout)	Immediately after 10 weeks of participation
Primary	Feasibility: Intervention adherence	Intervention adherence (>75% in at least 2 of 3 sessions)	Immediately after 10 weeks of participation
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Behavior: Knowledge	Knowledge on benzodiazepine risks/benefits will be assessed with 8 True/False questions	Week 0 and Immediately after 10 weeks of participation
Secondary	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