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Trial record 5 of 134 for:    depression pittsburgh | Open Studies

Treatment Resistant Depression and Insomnia in Older Veterans

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by VA Pittsburgh Healthcare System
Information provided by (Responsible Party):
VA Pittsburgh Healthcare System Identifier:
First received: November 17, 2016
Last updated: February 6, 2017
Last verified: February 2017
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.

Condition Intervention
Treatment Resistant Depression
Behavioral: Brief Behavioral Treatment for Insomnia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Treatment Resistant Depression and Insomnia in Older Veterans: A Pilot Study

Further study details as provided by VA Pittsburgh Healthcare System:

Primary Outcome Measures:
  • MADRS score ( depression) [ Time Frame: 8 weeks ]
  • ISI score ( insomnia) [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Short Form Survey (SF-12) SF-12 ( quality of life) [ Time Frame: 8 weeks ]
  • Patient Health Questionnaire (PHQ) PHQ-9 ( depression) [ Time Frame: 8 weeks ]
  • Emotional Closeness Questionnaire ( ECQ) [ Time Frame: 8 weeks ]

Estimated Enrollment: 30
Study Start Date: April 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BBTI
Participants 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.
Behavioral: Brief Behavioral Treatment for Insomnia
Other Name: BBTI
No Intervention: Control
Participants 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.

Detailed Description:

Quantitative and qualitative methods will be used to obtain information to aid in developing treatment approaches appropriate for older Veterans with TRD and insomnia. Qualitative data will be gathered to better understand Veterans' preferences for treatment approaches, particularly relating to preference for pharmacotherapy versus augmentation with a behavioral intervention such as BBTI. Using a Randomized Controlled Trial (RCT) design, we will test whether augmentation with BBTI will be acceptable to older Veterans and improve treatment response in those whose depression has not improved with antidepressant pharmacotherapy alone and assess for an association between preference and treatment response. Our aims and hypotheses are:

Aim 1: To characterize the depression, insomnia, and relevant clinical and neuropsychiatric characteristics of older Veterans with TRD.

H1a: In Veterans with TRD, Antidepressant History Form (ATHF) scores will have a positive association with Montgomery-Asberg Depression Rating scale (MADRS) scores.

H1b: In Veterans with TRD, MADRS scores will have a positive association with Insomnia Severity Index (ISI) scores.

Aim 2: Perform qualitative interviews in older Veterans to collect information about their views of their depression and insomnia and attitudes and preferences for treatment of both depression and insomnia.

Aim 3: To examine the feasibility of using BBTI to treat Veterans with TRD and insomnia.

H3a: Use of BBTI will be feasible in older adults with TRD as defined by acceptability and retention.

Aim 4: To determine if antidepressant augmentation with BBTI leads to improvement in scores on MADRS and ISI scales in older Veterans receiving BBTI versus those receiving only antidepressant optimization.

H4a: Augmentation with BBTI will improve both MADRS and ISI scores relative treatment with antidepressant alone.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Inclusion Criteria:

    • Age ≥ 60
    • Diagnosis of Major Depressive Disorder (MDD)
    • Diagnosis of Insomnia Disorder
    • Must have failed ≥ 1 antidepressant trial
  • Exclusion Criteria:

    • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02971150

Contact: Marie Anne Gebara, MD 412 360 2850
Contact: Lisa Lederer, MS 412 360 2364

United States, Pennsylvania
VA Pittsburgh Healthcare System Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Marie Anne Gebara, MD    412-360-2850   
Sponsors and Collaborators
VA Pittsburgh Healthcare System
  More Information

Responsible Party: VA Pittsburgh Healthcare System Identifier: NCT02971150     History of Changes
Other Study ID Numbers: PRO0001567
Study First Received: November 17, 2016
Last Updated: February 6, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on May 25, 2017