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NCT02165839 · ClinicalTrials.gov registry record · NA
Brief Behavioral Intervention for Insomnia During Chemotherapy
A NA study, sponsored by Stanford University.
- Completed
- Registry status
- NA
- Development phase
- 139
- Enrollment target
NCT02165839: Completed NA study, sponsored by Stanford University.
NCT02165839 is a NA study that has completed, run by Stanford University. The registered enrollment target is 139 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02165839, a NA study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- NA
- Development phase
- 139 participants
- Enrollment target
Study 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
Primary Outcome
The effects of the Brief Behavioral Therapy for Insomnia (BBT-I) intervention on insomnia will be measured by the Insomnia Severity Index (ISI). The ISI survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater i
Interventions
- BEHAVIORAL Brief Behavioral Therapy for Insomnia (BBT-I)
- BEHAVIORAL Healthy Eating Education Learning (HEAL)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2015-01 |
| Est. Completion | 2020-06 |
| Phase | NA |
What the finished NCT02165839 record still lists
NCT02165839 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Brief Behavioral Therapy for Insomnia (BBT-I) is the first listed.
NCT02165839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02165839 about?
NCT02165839 is a clinical study titled "Brief Behavioral Intervention for Insomnia During Chemotherapy". 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 ...
What is the current status of trial NCT02165839?
This trial is currently completed. It is a NA study. The enrollment target is 139 participants. The study started on 2015-01. Estimated completion is 2020-06.
What interventions are being tested in trial NCT02165839?
The interventions under investigation include: Brief Behavioral Therapy for Insomnia (BBT-I) (BEHAVIORAL), Healthy Eating Education Learning (HEAL) (BEHAVIORAL).
Who is sponsoring clinical trial NCT02165839?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02165839's enrollment target sits among peer trials
139 720th of 2000 higher than 1,281 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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