Benzodiazepine UseNCT06119308
Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing
A study testing Benzodiazepine Medication Taper with Cognitive Behavioral Therapy in people with Benzodiazepine Use and Insomnia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Benzodiazepine Use, Insomnia, Anxiety
- What is being tested?
- Benzodiazepine Medication Taper with Cognitive Behavioral Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2023to 8 Jun 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prescribed chronic benzodiazepines by their primary care clinicians at a Beth Israel Deaconess Medical Center (BIDMC) Primary Care Clinic.
Who cannot join
- Primary Care Practitioner (PCP) opt out
- Severe anxiety or depression symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Pilot of a Brief Cognitive Behavioral Therapy Intervention to Enhance Benzodiazepine Deprescribing in Older Adults
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.
Read the 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.
- Conditions
- Benzodiazepine Use, Insomnia, Anxiety
- Being tested
- Benzodiazepine Medication Taper with Cognitive Behavioral Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzodiazepine Medication Taper with Cognitive Behavioral TherapyOther
Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing (led by pharmacist/clinician/psychologist) over a 10-week Trial.
| Study group | Role | What they receive |
|---|---|---|
| Benzodiazepine Medication Taper with Cognitive Behavioral Therapy | Experimental | Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing Receives: Other: Benzodiazepine Medication Taper with Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Retention
Recruitment, retention (<10% dropout)
Measured: Immediately after 10 weeks of participation
Feasibility: Intervention adherence
Intervention adherence (>75% in at least 2 of 3 sessions)
Measured: 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.
Measured: Immediately after 10 weeks of participation
Change in Benzodiazepine Use
Patient-reported benzodiazepine medication doses with change measured by % change from baseline dose.
Measured: From enrollment to end of intervention at 10 weeks.
Change in Sleep Disturbance Scores
PROMIS Sleep Short Form 8b survey.
Measured: From enrollment to end of intervention at 10 weeks.
Change in Anxiety Scores
PROMIS Anxiety Short Form 8a Survey.
Measured: From enrollment to end of intervention at 10 weeks.
Secondary outcomes (6)
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.
Measured: Week 0 and Immediately after 10 weeks of participation
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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Up to 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start8 Nov 2023
- Primary completion30 Oct 2024
- Study completion8 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benzodiazepine UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gloria Y. Yeh, Beth Israel Deaconess Medical Center
- Investigators
- Gloria Yeh, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119308
- Sponsor's protocol ID
- 2023P000382
- Status last verified
- Feb 2026
- First submitted
- 27 Oct 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 Aug;41(10):2823-2834. doi: 10.1007/s11606-026-10356-z. Epub 2026 Mar 16.
PubMed 41840339