InsomniaCBT-INCT02779023
Integrative Cardiac Health Project Cognitive-Behavior Therapy for Insomnia
A study testing Cognitive-Behavior Therapy for Insomnia (CBT-I) in people with Insomnia and Cardiovascular Risk Factor, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Cardiovascular Risk Factor
- What is being tested?
- Cognitive-Behavior Therapy for Insomnia (CBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2015to 11 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Cardiac Health Project, Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
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.
Read the 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.
- Conditions
- Insomnia, Cardiovascular Risk Factor
- Being tested
- Cognitive-Behavior Therapy for Insomnia (CBT-I)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavior Therapy for Insomnia (CBT-I)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive-Behavior Therapy for Insomnia (CBT-I) |
| ICHP Only | No intervention | Participants in this arm will receive the usual care (ICHP program). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
collected through sleep diary and actigraphy
Measured: 2 months, 4 months, and 6 months
Secondary outcomes (7)
Insomnia Severity Index
7-item self report measure of insomnia symptoms
Measured: 2 months, 4 months, and 6 months
Perceived Stress
14-item self report of perceived stress
Measured: 2 months, 4 months, and 6 months
Patient Health Questionnaire-9
9-item self report measure of depressive symptoms
Measured: 2 months, 4 months, and 6 months
Multidimensional Fatigue Inventory
20-item self report measure of fatigue
Measured: 2 months, 4 months, and 6 months
Epworth Sleepiness Scale
7-item self report measure of sleepiness
Measured: 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
Measured: 2 months and 6 months
Pittsburgh Sleep Quality Index
11-item self report measure of sleep quality
Measured: 2 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start29 Oct 2015
- Primary completion11 Jul 2016
- Study completion11 Jul 2016
Why it stopped: Methodology of subject enrollment would require significant modification.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
- Investigators
- Todd C Villines, MD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779023
- Sponsor's protocol ID
- 404030
- Acronym
- CBT-I
- Status last verified
- Sep 2018
- First submitted
- 18 Apr 2016
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Cardiac Health Project Cognitive-Behavior Therapy for Insomnia
- ClinicalTrials.gov ID
- NCT02779023
- Acronym / sponsor ID
- CBT-I / 404030
- Conditions
- Insomnia, Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Methodology of subject enrollment would require significant modification.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- Uniformed Services University of the Health Sciences
- Study start
- 29 Oct 2015 (actual)
- Primary completion
- 11 Jul 2016 (actual)
- Study completion
- 11 Jul 2016 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICHP + CBT-I | Experimental | Behavioral: Cognitive-Behavior Therapy for Insomnia (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. |
| ICHP Only | No intervention | –Participants in this arm will receive the usual care (ICHP program). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavior Therapy for Insomnia (CBT-I) | Behavioural | ICHP + CBT-I |
Primary outcome
Sleep Efficiency
Time frame: 2 months, 4 months, and 6 months
collected through sleep diary and actigraphy
7 secondary outcomes
Insomnia Severity Index
Time frame: 2 months, 4 months, and 6 months
Perceived Stress
Time frame: 2 months, 4 months, and 6 months
Patient Health Questionnaire-9
Time frame: 2 months, 4 months, and 6 months
Multidimensional Fatigue Inventory
Time frame: 2 months, 4 months, and 6 months
Epworth Sleepiness Scale
Time frame: 2 months, 4 months, and 6 months
Functional Outcomes of Sleep Questionnaire-10
Time frame: 2 months and 6 months
Pittsburgh Sleep Quality Index
Time frame: 2 months and 6 months
Results and safety
The study was stopped early (reason given: Methodology of subject enrollment would require significant modification.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd C Villines, MD principal investigator
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavior Therapy for Insomnia (CBT-I) in people with Insomnia and Cardiovascular Risk Factor, run by Walter Reed National Military Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Methodology of subject enrollment would require significant modification.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (time frame: 2 months, 4 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.