Integrative Cardiac Health Project Cognitive-Behavior Therapy for Insomnia
| Status: | Terminated |
|---|---|
| Conditions: | Insomnia Sleep Studies, Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/13/2018 |
| Start Date: | October 29, 2015 |
| End Date: | July 11, 2016 |
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.
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.
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.
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.
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)
We found this trial at
1
site
Bethesda, Maryland 20889
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