Adjunctive Brief Behavioral Treatment of Insomnia (BBTI) for Sleep Intervention (SI)

NCT02248675 | Completed Results

• 2 other identifiers: PPO 13-373I21HX001473
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

There is a strong association between sleep disturbance and suicidal thoughts and behaviors. Sleep disturbance is also highly comorbid with other common conditions associated with suicide such as depression and posttraumatic stress disorder. Accordingly, this application focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a broad range of Veterans. This pilot proposal specifically examines how Cognitive Behavioral Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal ideation in Veterans who also suffer from additional conditions. The proposal further suggests that adding this sleep intervention to usual care may further enhance overall care by increasing the utilization of recommended treatments for depression and posttraumatic stress disorder.

Conditions

Insomnia; Depression; Posttraumatic Stress Disorder; Suicidal Ideation

Keywords

sleep disorders; insomnia; suicidal ideation; Depression; Depressive disorders; PTSD; anxiety disorders; suicide; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Columbia Suicide Severity Rating Scale (C-SSRS)

  The entire Columbia Suicide Severity Rating Scale (C-SSRS) will be administered, but the investigators will use its' Suicidal Ideation Intensity scale (0-25 score range summed from five items, with higher scores indicating more severe suicidal ideation) as the primary outcome.

  post-treatment (~6-8 weeks)

Secondary Outcomes (3)

• Perceived Treatment Beliefs (PTS)

  post-treatment (~6-8 weeks)

• Patient Health Questionnaire-9 (PHQ-9)

  post-treatment (~6-8 weeks)

• Insomnia Severity Index (ISI)

  post-treatment (~6-8 weeks)

Study Arms (2)

CBT-I + TAU

EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).

Behavioral: CBT-I; Other: TAU

TAU

ACTIVE COMPARATOR

Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.

Other: TAU

Interventions

CBT-I BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.

CBT-I + TAU

TAU OTHER

Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.

CBT-I + TAU; TAU

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking male and female Veterans ages 18-70;
• demonstrate an understanding of the informed consent;
• seeking or receiving services at the Canandaigua VA Medical Center (VAMC) or Rochester Outpatient Clinic;
• endorse death/suicidal ideation on the Columbia Suicide Severity Rating Scale
• either (i) a current diagnosis in their medical record of Major Depressive Disorder, Depression not otherwise specified, PTSD,or (ii) evidence of current depression as indicated by a score of \> 10 on the Patient Health Questionnaire (PHQ-9) or current PTSD as indicated by a score of \> 38 on the PTSD Symptom Checklist (PCL-5)();
• have an Insomnia Severity Index score \> 10 indicating clinically meaningful insomnia with at least 1 insomnia-related daytime consequence (score of 1 on item #3) and trouble sleeping 3 months

You may not qualify if:

• history of serious mental illness such as schizophrenia, Bipolar I or II disorder, or current psychiatric conditions such as psychosis, mania, dementia, cognitive impairment, OR suicidal ideation with plan and intent, a report of a suicide attempt in the past 6 months in the Computerized Patient Record System (CPRS) or via self-report, or a score of 4 on the Columbia-Suicide Severity Rating Scale
• currently engaged in inpatient or partial hospitalization programs or ongoing/pending medical procedures that could inhibit sleep
• recent substance dependence disorder with \< 3 months in remission or abstinence;
• suspicion of or evidence of untreated sleep apnea.
• Diagnosis of a circadian rhythm disorder
• Diagnosis of Narcolepsy
• History of Seizures

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression; Stress Disorders, Post-Traumatic; Suicidal Ideation; Sleep Wake Disorders; Depressive Disorder; Anxiety Disorders; Suicide

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Self-Injurious Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mood Disorders

Results Point of Contact

• Title: Wilfred R. Pigeon, PhD
• Organization: VA Center of Excellence for Suicide Prevention

wilfred.pigeon2@va.gov

(585) 393-7945

Study Officials

• Wilfred R Pigeon, PhD

  Syracuse VA Medical Center, Syracuse, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 25, 2014
• Study Start: February 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 28, 2017
• Results First Posted: April 28, 2017

Record last verified: 2017-03

Locations

US (1)