Implementation of Brief Insomnia Treatments - Clinical Trial

Completed · Not applicable

Conditions studied: Chronic Insomnia

In brief

The purpose of this study is to directly compare the effectiveness of two interventions for insomnia: Brief Behavioral Treatment for Insomnia (BBTI) vs. Cognitive Behavioral Therapy for Insomnia (CBTI).

Key facts

Study ID

NCT02724800

Run by

VA Pittsburgh Healthcare System

People needed

92

Starts

2016-04-01

Expected to finish

2020-03-01

Last updated by the study team

2020-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years old and older
• Military Veteran
• Insomnia Severity Index (ISI) ≥15 \& Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for insomnia disorder
• If using sleep medications, medication and dosage have not been changed in the past month, and will remain unchanged for the duration of the treatment phase of the study (i.e., 4-8 weeks)
• If using other psychotropic medications, medication and dosage have not been changed in the past 2 months, and will remain unchanged for the duration of the treatment phase of the study (i.e., 4-8 weeks)

You may not qualify if…

• Untreated, current, and severe PTSD as determined by the Structured Clinical Interview for DSM-5 (SCID)
• Untreated, current, and severe Major Depressive Disorder as determined by the SCID
• Current/Past Psychotic or Bipolar disorder
• Current substance or alcohol use disorder as determined by the SCID
• Current unstable medical condition
• Hospitalization in the previous 1 month for a medical condition or surgery for which recovery overlaps with the study onset and duration
• Seizure disorder, open skull brain injury, or moderate to severe traumatic brain injury (TBI)
• Current, untreated, sleep disorders such as nightmare disorder, restless legs syndrome, circadian rhythm disorder (or shift work), or a suspected sleep disorder requiring polysomnographic assessment, such as obstructive sleep apnea or periodic leg movements as determined by the South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR) Clinical Interview for DSM-5 Sleep-Wake Disorders and/or the STOP-BANG questionnaire
• Moderate to severe cognitive impairment (St. Louis University Mental Status [SLUMS] exam ≤20) and/or diagnosis in medical record indicative of moderate to severe cognitive impairment
• Unstable environment that is not in one's control (e.g., homeless, temporary group home, care taking duties at night)
• Pregnancy and/or breast-feeding
• STOP-BANG is not a true acronym but indicates the symptoms each item assess:
• S-snores T-tired/sleepy O-observed apneas P-high blood pressure
• B-body mass index A-age N-neck circumference G-gender

Where it is running

• VA Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.