CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 139 enrolled
Drug / intervention
Brief Behavioral Therapy for Insomnia (BBT-I) +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/NCT02165839
NCT02165839N/ACompleted

Brief Behavioral Intervention for Insomnia During Chemotherapy

Stanford University·interventional·Posted Jun 18, 2014·Updated Dec 3, 2020

In Brief

A clinical study evaluating Brief Behavioral Therapy for Insomnia (BBT-I) and Healthy Eating Education Learning (HEAL) for Breast Cancer and Insomnia. Completed, enrolled 139 participants across 1 site.

Detailed Summary

PRIMARY OBJECTIVE(S): To evaluate the efficacy of the Brief Behavioral Therapy for Insomnia (BBT-I) in treating insomnia among breast cancer patients receiving chemotherapy. SECONDARY OBJECTIVE(S): * To evaluate the efficacy of the BBT-I in treating cancer-related symptoms such as cancer-related fatigue and cognitive difficulties in breast cancer patients receiving chemotherapy. * To examine potential moderators and mediators of BBT-I intervention effects on insomnia, cognitive difficulties, and fatigue. In particular, we are interested in age, depression and anxiety and side effects (hot flashes) as potential moderators of the intervention effects as well as evaluating modifiable behavioral and physiological mechanisms as hypothesized mediators

Study Details

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

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 18, 2014
Enrollment StartJan 1, 2015
Primary CompletionJun 19, 2019
Study CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 12.0 years ago

Interventions

Brief Behavioral Therapy for Insomnia (BBT-I)behavioral

Healthy Eating Education Learning (HEAL)behavioral