Treatment Resistant Depression and Insomnia in Older Veterans
1 other identifier
interventional
12
1 country
1
Brief Summary
The purpose of this pilot study is to obtain information about older Veterans' preferences for treatment of depression and insomnia and to pilot test the feasibility and clinical effect of Brief Behavioral Treatment for Insomnia (BBTI) BBTI for older Veterans living with Treatment Resistant Depression (TRD) and insomnia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 17, 2016
CompletedFirst Posted
Study publicly available on registry
November 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedJune 1, 2017
May 1, 2017
11 months
November 17, 2016
May 30, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
PHQ-9 ( depression)
8 weeks
ISI score ( insomnia)
8 weeks
Secondary Outcomes (2)
Short Form Survey (SF-12) SF-12 ( quality of life)
8 weeks
Emotional Closeness Questionnaire ( ECQ)
8 weeks
Study Arms (2)
BBTI
EXPERIMENTALParticipants will receive Brief Behavioral Treatment for Insomnia (BBTI). This will be administered over the course of 4 weeks. BBTI is based on the concepts of sleep restriction and stimulus control. The first and third session are in person and the 2 and 4th session are conducted over the phone. Throughout the treatment, participants will complete daily sleep dairies. After 4 weeks of treatment, participants randomized to this group will cross over to the no intervention group and will be called once a week to assess mood and sleep symptoms.
Control
NO INTERVENTIONParticipants will not receive treatment. They will be contacted by phone once a week to complete assessments of mood and sleep. After 4 weeks, they will cross over to the experimental BBTI group.
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 60
- Diagnosis of Major Depressive Disorder (MDD)
- Diagnosis of Insomnia Disorder
- Must have failed ≥ 1 antidepressant trial
You may not qualify if:
- Lifetime/current Bipolar I/II diagnosis
- Lifetime/current Schizophrenia Spectrum Disorder diagnosis
- Substance Use Disorder within past 3 months
- High Suicide Risk that cannot be safely managed
- Untreated Obstructive Sleep Apnea (OSA)
- Restless Legs Syndrome
- Rapid Eye Movement (REM) Sleep Behavior Disorder
- Active OR untreated Post Traumatic Stress Disorder (PTSD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2016
First Posted
November 22, 2016
Study Start
April 1, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
June 1, 2017
Record last verified: 2017-05