Clinical trial NCT06119308: Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing
Official title: Pilot of a Brief Cognitive Behavioral Therapy Intervention to Enhance Benzodiazepine Deprescribing in Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Benzodiazepine Use
Insomnia
Anxiety
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: University of Pittsburgh
First posted: 2023-11-07
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility: Retention
timeFrame: Immediately after 10 weeks of participation
measure: Feasibility: Intervention adherence
timeFrame: Immediately after 10 weeks of participation
measure: Acceptability: Open-ended qualitative interview
timeFrame: Immediately after 10 weeks of participation
measure: Change in Benzodiazepine Use
timeFrame: From enrollment to end of intervention at 10 weeks.
measure: Change in Sleep Disturbance Scores
timeFrame: From enrollment to end of intervention at 10 weeks.
measure: Change in Anxiety Scores
timeFrame: From enrollment to end of intervention at 10 weeks.
Secondary outcomes:
measure: Behavior: Self-efficacy measured by 7-point Likert scale questions
timeFrame: Week 0 and Immediately after 10 weeks of participation
measure: Behavior: Intentions on tapering measured by a 15-point validated scale
timeFrame: Week 0 and Immediately after 10 weeks of participation
measure: Behavior: Attitudes on benzodiazepine use measured by 7-point Likert scale
timeFrame: Week 0 and Immediately after 10 weeks of participation
measure: Behavior: Knowledge on benzodiazepine risk/benefits measured by true/false questions
timeFrame: Week 0 and Immediately after 10 weeks of participation
measure: Behavior: Norms of using benzodiazapine medications measured by 7-point Likert Scale
timeFrame: Week 0 and Immediately after 10 weeks of participation
measure: Sustainability of Intervention Effect measured by electronic health record review
timeFrame: Up to 6 months post intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Gloria Yeh, MD
role: PRINCIPAL_INVESTIGATOR
References: