CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 132 enrolled
Drug / intervention
CBTI plus taper method A +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03511209
NCT03511209N/ACompleted

The Efficacy of Masked Tapering on Discontinuation of Hypnotics in Older Veterans

VA Office of Research and Development·interventional·Posted Apr 27, 2018·Updated Nov 14, 2024

In Brief

A clinical study evaluating CBTI plus taper method A and CBTI plus taper method B for Insomnia. Completed, enrolled 132 participants across 1 site.

Detailed Summary

Sleeping medications, called hypnotics, are often prescribed for insomnia. About one-quarter of Veterans use hypnotics (or bedtime alcohol). Older patients who use hypnotics fall more often and have worse memory than those who do not use them. Stopping hypnotics often reverses these problems. The Department of Veterans Affairs (VA) is trying to reduce hypnotic use among older adults. Currently, there are two main treatments to help patients stop using hypnotics. The first treatment involves a slow decrease in the daily dose until the hypnotic is ultimately discontinued. For safety, the process of decreasing the daily dose is usually supervised by a physician. The second is a treatment for insomnia called cognitive behavioral therapy for insomnia (CBTI). This study will compare a novel hypnotic tapering method to the usual tapering method offered to older Veterans. The purpose of the study is to determine if the novel tapering method is more effective than the usual tapering method, both in terms of hypnotic discontinuation and improvement in insomnia severity. Participants will be recruited from among Veterans 55 years and older who receive care from one VA Healthcare System. Following a baseline assessment, participants will be randomly assigned to one of the two 8-week treatment groups (66 participants per group). Each treatment group will receive CBTI, however, one group will receive the novel tapering program and the other group the usual tapering program. Follow-up assessments will be conducted at post-treatment and at 6-months after completion of the treatment. If the novel tapering program is effective, it will represent a treatment option that can be offered to older Veterans who want to discontinue hypnotics. This tapering program could help VA healthcare providers adhere to clinical guidelines that recommend benzodiazepine discontinuation among older adults. A reduction in chronic hypnotic use may in turn reduce the risk of falls and hip fractures, which ultimately may improve the health and quality of life of older Veterans who receive healthcare at the VA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 27, 2018
Enrollment StartDec 10, 2018
Primary CompletionNov 27, 2023
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 8.2 years ago

Interventions

CBTI plus taper method Abehavioral

This intervention includes CBTI plus the novel hypnotic tapering method.

CBTI plus taper method Bbehavioral

This intervention includes CBTI plus the usual hypnotic tapering method used by the VA.