Clinical trial NCT02779023: Integrative Cardiac Health Project Cognitive-Behavior Therapy for Insomnia
Official title: Integrative Cardiac Health Project Cognitive-Behavior Therapy for Insomnia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insomnia
Cardiovascular Risk Factor
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
Collaborators: name: Uniformed Services University of the Health Sciences
First posted: 2016-05-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Sleep Efficiency
timeFrame: 2 months, 4 months, and 6 months
Secondary outcomes:
measure: Insomnia Severity Index
timeFrame: 2 months, 4 months, and 6 months
measure: Perceived Stress
timeFrame: 2 months, 4 months, and 6 months
measure: Patient Health Questionnaire-9
timeFrame: 2 months, 4 months, and 6 months
measure: Multidimensional Fatigue Inventory
timeFrame: 2 months, 4 months, and 6 months
measure: Epworth Sleepiness Scale
timeFrame: 2 months, 4 months, and 6 months
measure: Functional Outcomes of Sleep Questionnaire-10
timeFrame: 2 months and 6 months
measure: Pittsburgh Sleep Quality Index
timeFrame: 2 months and 6 months
Other outcomes:
measure: Insomnia Treatment Acceptability Scale-Behavior Subscale
timeFrame: 2 weeks and again at 2 months
measure: Insomnia Treatment Evaluation Measure-Revised
timeFrame: 2 months
Locations:
city: Bethesda
country: United States
facility: Integrative Cardiac Health Project, Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Walter Reed National Military Medical Center
name: Todd C Villines, MD
role: PRINCIPAL_INVESTIGATOR
References: