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
- Are there results?
- None posted in the registry
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.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of a Brief Cognitive Behavioral Therapy Intervention to Enhance Benzodiazepine Deprescribing in Older Adults
- ClinicalTrials.gov ID
- NCT06119308
- Acronym / sponsor ID
- 2023P000382
- Conditions
- Benzodiazepine Use, Insomnia, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- University of California, San Francisco, University of Pittsburgh
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 8 Jun 2025 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benzodiazepine Medication Taper with Cognitive Behavioral Therapy | Experimental | Other: Benzodiazepine Medication Taper with Cognitive Behavioral TherapyBrief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prescribed chronic benzodiazepines by their primary care clinicians at a Beth Israel Deaconess Medical Center (BIDMC) Primary Care Clinic.
Key exclusion criteria (2 listed)
- Primary Care Practitioner (PCP) opt out
- Severe anxiety or depression symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benzodiazepine Medication Taper with Cognitive Behavioral TherapyBrief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing (led by pharmacist/clinician/psychologist) over a 10-week Trial. | Other | Benzodiazepine Medication Taper with Cognitive Behavioral Therapy |
Primary outcome
Feasibility: Retention
Time frame: Immediately after 10 weeks of participation
Recruitment, retention (<10% dropout)
Feasibility: Intervention adherence
Time frame: Immediately after 10 weeks of participation
Intervention adherence (>75% in at least 2 of 3 sessions)
Acceptability: Open-ended qualitative interview
Time frame: 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
Time frame: 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
Time frame: From enrollment to end of intervention at 10 weeks.
PROMIS Sleep Short Form 8b survey.
Change in Anxiety Scores
Time frame: From enrollment to end of intervention at 10 weeks.
PROMIS Anxiety Short Form 8a Survey.
6 secondary outcomes
Behavior: Self-efficacy measured by 7-point Likert scale questions
Time frame: Week 0 and Immediately after 10 weeks of participation
Behavior: Intentions on tapering measured by a 15-point validated scale
Time frame: Week 0 and Immediately after 10 weeks of participation
Behavior: Attitudes on benzodiazepine use measured by 7-point Likert scale
Time frame: Week 0 and Immediately after 10 weeks of participation
Behavior: Knowledge on benzodiazepine risk/benefits measured by true/false questions
Time frame: Week 0 and Immediately after 10 weeks of participation
Behavior: Norms of using benzodiazapine medications measured by 7-point Likert Scale
Time frame: Week 0 and Immediately after 10 weeks of participation
Sustainability of Intervention Effect measured by electronic health record review
Time frame: Up to 6 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Derived from this study: PubMed 41840339Anderson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gloria Yeh, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Retention (time frame: Immediately after 10 weeks of participation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06119308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.