Integrative Cardiac Health Project Cognitive-Behavior Therapy for Insomnia (CBT-I)

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.

Study Overview

• Status: Terminated
• Conditions: Insomnia; Cardiovascular Risk Factor
• Intervention / Treatment: Behavioral: Cognitive-Behavior Therapy for Insomnia (CBT-I)

Detailed Description

Methodology: Up to 76 total male and female patients enrolled in the ICHP who meet criteria for insomnia will be recruited. All ICHP patients meet the following criteria before enrolling in the program: military beneficiaries at least 18 years of age who are self-referred or referred by their physician.

Randomization: Participants will be selected for treatment groups based on a block randomization scheme. The total number of blocks will be 19, and the number of subjects per block will be 4. The treatment labels will be: ICHP and ICHP + CBT-I. The randomization scheme varies the sequence of treatment categories in each block.

Allocation concealment: The allocation sequence will be concealed from the research team enrolling participants in sequentially numbered, opaque, sealed, and stapled envelopes.

Once randomized, patients identified for the study will participate in the ICHP group or the ICHP + CBT-I group (which consists of the ICHP program plus a 6-session CBT-I treatment). The 6 sessions will consist of 4 in-person appointments and two telephone appointments. Each in-person session will be approximately 1 hour, and each phone session will be approximately 30 minutes.

The study data will be analyzed in two phases. Phase I will be a pilot study to determine the feasibility and acceptability of CBT-I within the ICHP program.

Phase II will be implementation of the full RCT to determine the effectiveness of the CBT-I intervention compared to ICHP usual care. Data collected during Phase I will be utilized in the final analysis unless changes to the procedures which could affect outcome measures are made after participants begin.

Phase I (feasibility and acceptability): Primary outcomes for Phase I of the study will be descriptive statistics on feasibility and acceptability measures as well as qualitative responses to a post-treatment interview with participants. Secondary outcomes for Phase I will be between-group differences in sleep outcomes.

Minimum criteria for advancing to Phase II include the following:

• Recruitment rate: Average of 21 participants enrolled per year. If the recruitment rate during Phase I is not sufficient to enroll 21 participants per year during Phase II, it will be necessary to modify the recruitment strategy in order to increase the rate of participant enrollment before proceeding to Phase II.

• Treatment acceptability rate, as measured by both of the following:

  • 50% of Phase I participants scoring question 3 of the Insomnia Treatment Evaluation Measure-Revised (ITEM-R) as a "3" or "4."
  • Question 3 asks: "How satisfied are you with the treatment received"
  • Minimum of 50% of participants answering question 1 of the Post-Study Questionnaire ("Did you find this insomnia treatment valuable and useful to you?") as: ◦"Yes" (item a) or ◦"Moderately Useful" (item c)

Phase II (effectiveness of intervention): Primary outcomes for Phase II will be between-group differences in level of change in sleep outcomes. Secondary outcomes for Phase II will include: between-group differences in changes in depression, fatigue, perceived stress, sleepiness, and sleep-related quality of life. Tertiary outcomes (exploratory) will include changes in secondary cardiovascular risk factors.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Integrative Cardiac Health Project, Walter Reed National Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICHP + CBT-I; 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)
No Intervention: ICHP Only; Participants in this arm will receive the usual care (ICHP program).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Efficiency	collected through sleep diary and actigraphy	2 months, 4 months, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index	7-item self report measure of insomnia symptoms	2 months, 4 months, and 6 months
Perceived Stress	14-item self report of perceived stress	2 months, 4 months, and 6 months
Patient Health Questionnaire-9	9-item self report measure of depressive symptoms	2 months, 4 months, and 6 months
Multidimensional Fatigue Inventory	20-item self report measure of fatigue	2 months, 4 months, and 6 months
Epworth Sleepiness Scale	7-item self report measure of sleepiness	2 months, 4 months, and 6 months
Functional Outcomes of Sleep Questionnaire-10	10-item self report measure of the effect of sleepiness on daytime function	2 months and 6 months
Pittsburgh Sleep Quality Index	11-item self report measure of sleep quality	2 months and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Treatment Acceptability Scale-Behavior Subscale	8-item self report measure of perceived treatment acceptability	2 weeks and again at 2 months
Insomnia Treatment Evaluation Measure-Revised	6-item self report measure of the credibility and effectiveness of the insomnia treatment	2 months

Collaborators and Investigators

• Sponsor: Walter Reed National Military Medical Center
• Collaborators: Uniformed Services University of the Health Sciences
• Investigators: Principal Investigator: Todd C Villines, MD, Walter Reed National Military Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2015
• Primary Completion (Actual): July 11, 2016
• Study Completion (Actual): July 11, 2016

Study Registration Dates

• First Submitted: April 18, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 7, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 404030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO