Clinical trial NCT02971150: Treatment Resistant Depression and Insomnia in Older Veterans
Official title: Treatment Resistant Depression and Insomnia in Older Veterans: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Resistant Depression
Insomnia
Lead sponsor: VA Pittsburgh Healthcare System
Sponsor class: FED
First posted: 2016-11-22
Enrollment: 12
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 PHQ-9 and ISI scores relative treatment with antidepressant alone.

Eligibility criteria: * 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)

Primary outcomes:
measure: PHQ-9 ( depression)
timeFrame: 8 weeks
measure: ISI score ( insomnia)
timeFrame: 8 weeks
Secondary outcomes:
measure: Short Form Survey (SF-12) SF-12 ( quality of life)
timeFrame: 8 weeks
measure: Emotional Closeness Questionnaire ( ECQ)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
Study officials:
References: