Integrative Cardiac Health Project Cognitive-Behavior Therapy for Insomnia

NCT02779023 | Terminated

• 1 other identifier: 404030
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the feasibility, acceptability, and effectiveness of adding Cognitive-Behavioral Therapy for Insomnia (CBT-I) to the standard care received at the Integrative Cardiac Health Project (ICHP) on insomnia symptoms and severity. ICHP is an established cardiovascular disease prevention program to reduce cardiovascular disease risk through the adoption of lifestyle changes related to improvements in diet, stress, sleep, and exercise. The study will be conducted among patients with insomnia who are already enrolled in the ICHP cardiovascular risk prevention program. This is a single-center study, prospective, randomized, controlled, interventional trial within ICHP at the Walter Reed National Military Medical Center (WRNMMC). To conduct both phases of the study, up to 76 total male and female patients enrolled in ICHP who meet criteria for insomnia will be recruited. Participants who meet inclusion and exclusion criteria for this study, and consent to participate, will be randomized to one of two conditions: (1) ICHP, or (2) ICHP + CBT-I treatment. CBT-I treatment will consist of four in-person appointments and two telephone appointments.

Conditions

Insomnia; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• Sleep Efficiency

  collected through sleep diary and actigraphy

  2 months, 4 months, and 6 months

Secondary Outcomes (7)

• Insomnia Severity Index

  2 months, 4 months, and 6 months

• Perceived Stress

  2 months, 4 months, and 6 months

• Patient Health Questionnaire-9

  2 months, 4 months, and 6 months

• Multidimensional Fatigue Inventory

  2 months, 4 months, and 6 months

• Epworth Sleepiness Scale

  2 months, 4 months, and 6 months

Other Outcomes (2)

• Insomnia Treatment Acceptability Scale-Behavior Subscale

  2 weeks and again at 2 months

• Insomnia Treatment Evaluation Measure-Revised

  2 months

Study Arms (2)

ICHP + CBT-I

EXPERIMENTAL

Participants in this arm will receive the usual care (ICHP program) plus 6 Cognitive-Behavior Therapy for Insomnia (CBT-I) treatment sessions. Four of the treatment sessions will be in person and two will be over the phone.

Behavioral: Cognitive-Behavior Therapy for Insomnia (CBT-I)

ICHP Only

NO INTERVENTION

Participants in this arm will receive the usual care (ICHP program).

Interventions

Cognitive-Behavior Therapy for Insomnia (CBT-I) BEHAVIORAL

ICHP + CBT-I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older, Tricare beneficiary, participation in ICHP
• Sleep-onset or maintenance insomnia, defined as sleep-onset latency (SOL; time it takes to fall asleep) and/or wake after sleep onset (WASO; time spent awake after falling asleep) longer than 30 minutes per night at least 3 nights per week
• Insomnia duration of at least 3 months
• A complaint of at least 1 negative effect during waking hours (e.g., fatigue, impaired functioning, mood disturbances) that is attributed to insomnia
• Score of 8 or greater on the Insomnia Severity Index
• Pittsburgh Sleep Quality Index (PSQI) score of \> 5

You may not qualify if:

• Previous participation in the ICHP program
• Use of stimulant medications or acute high dose of steroids
• Suicidal ideation, as determined by a score of 1 or greater on question #9 of the Patient Health Questionnaire-9 (PHQ-9)
• Concurrent psychological or behavioral treatment for insomnia
• Current pregnancy by history, or plans to become pregnant in the next 6 months (excluded because of sleep difficulties which often occur during pregnancy that could confound the results)

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Integrative Cardiac Health Project, Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Todd C Villines, MD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: May 20, 2016
• Study Start: October 29, 2015
• Primary Completion: July 11, 2016
• Study Completion: July 11, 2016
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)