InsomniaiTAP-VNCT03804788
The Insomnia Treatment and Problems Study for Veterans
A study testing Cognitive Behavioral Therapy for Insomnia and Sleep Hygeine in people with Insomnia and Alcohol; Harmful Use, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Alcohol; Harmful Use
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia and Sleep Hygeine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2019to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Veteran deployed for military service after September 11, 2001
- 1+ heavy drinking episode (4/5+ drinks in 2 hours for women/men) in past 30 days
- DSM-5 and research diagnostic criteria for Insomnia Disorder
Who cannot join
- Inability to provide informed consent
- Cognitive impairment
- Contraindications for CBT-I (mania or seizure disorder)
- Untreated sleep disorder requiring more than behavioral treatment for insomnia
- Engagement in overnight shift work at baseline
- Care of a child under 1 year of age
Show all 9Show fewer
- Severe or untreated psychiatric disorder that requires immediate clinical attention
- Current behavioral treatment for insomnia or alcohol use
- Initiation of sleep medication in the past 6 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia
Columbia, Missouri, 65212
About this study
Official title: The Impact of Insomnia Treatment on Heavy Alcohol Use Among Returning Veterans
This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.
Read the detailed description
More than half of returning Veterans who screen positive for hazardous drinking report clinically significant symptoms of insomnia. In turn, insomnia symptoms have been associated with increased risk of alcohol-related problems, perhaps due to insomnia-related impairments in executive functioning, negative emotionality, and craving. The proposed project aims to examine improvements in insomnia as a mechanism for improvement in alcohol use among heavy-drinking Veterans with insomnia. Forty-four returning Veterans who report heavy drinking (≥4/5 drinks per occasion for women/men) and have insomnia based on DSM-5 and research diagnostic criteria will participate in a randomized pilot trial. Participants will be randomly assigned to receive personalized normative alcohol feedback in the context of one of two treatment conditions: CBT-I (n = 22) or a sleep hygiene education control (SH; n = 22). Outcomes will be assessed at the end of the active intervention period (6 weeks), mid-treatment (after 3 sessions), and at 3 months post-intervention. Outcomes of interest include insomnia severity, total wake time, sleep quality, drinking quantity/frequency, alcohol-related consequences, executive functioning, negative affect, emotion regulation, craving for alcohol, and use of alcohol as a sleep aid.
- Conditions
- Insomnia, Alcohol; Harmful Use
- Being tested
- Cognitive Behavioral Therapy for Insomnia, Sleep Hygeine
- Keywords
- alcohol, drinking, sleep, insomnia, veteran
- 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 Behavioral Therapy for InsomniaBehavioural
Also called (CBT-I)
Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. A sixth week of treatment will be included - and scheduled for the same date as the post-treatment assessment - if the participant and research team agree that it would be beneficial (e.g., if a participant has difficulty grasping cognitive therapy concepts). Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.
Sleep HygeineBehavioural
All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Experimental | Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for six (6) weeks. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Sleep Hygeine |
| Sleep Hygiene | Active comparator | Sleep hygiene handout delivered once to all participants. Receives: Behavioral: Sleep Hygeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number of eligible participants who enrolled in the study
Measured: Assessed at baseline
Retention
Number of participants who complete all treatment sessions
Measured: Assessed at post-treatment (week 6)
Drinking Quantity
Assessed using Daily Drinking Questionnaire. Participants report the number of standard drinks consumed on each day of a typical week in the past month (on Monday, Tuesday, Wednesday, etc). Responses for each day are then summed to calculate a total "drinks per week" variable, where higher scores indicate more standard drinks.
Measured: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Alcohol-related Consequences
Assessed using the Brief Young Adult Alcohol Consequences Questionnaire, which asks participants to indicate (yes/no) which of 24 consequences they have experienced in the past month. Responses range from 0 to 24, with greater scores indicating more consequences.
Measured: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Insomnia Symptoms
Assessed using Insomnia Severity Index (ISI). ISI scores from 0 to 28, with higher scores indicating more severe insomnia.
Measured: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Sleep Quality
On daily sleep diaries, participants reported sleep quality on a scale from 0 (very poor) to 4 (very good). Higher scores indicate better sleep quality.
Measured: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Sleep Efficiency
Daily sleep diaries were used to calculate the amount of time that participants spent sleeping out of all the time they spent in bed. Values from 0 to 100, with higher scores indicating better sleep efficiency. The treatment goal is 85%.
Measured: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Client Satisfaction
Assessed using the 8-item Client Satisfaction Questionnaire. Participants rate their satisfaction with insomnia treatment on a scale from 1 (poor) to 4 (excellent). Scores were summed and then divided by the number of items to create a meaningful standardized score. Higher scores indicate greater satisfaction.
Measured: Mean score at post-treatment (week 6).
Secondary outcomes (6)
Delay Discounting
Assessed using the Monetary Choice Questionnaire (MCQ). Participants indicate if they would rather receive a smaller amount of money now or a greater amount of money in a specified amount of time (e.g., 100 days, 2 days). The MCQ is scored using a logarithmic subject-specific discount rate (k variable). K values typically fall between 0.0 and 0.5, with higher values indicating a preference for smaller, immediate rewards over larger, delayed reward ("delay discounting").
Measured: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Negative Affect
Assessed using the Positive and Negative Affect Schedule. Participants indicate using a 1 (not at all) - 5 (extremely) scale to indicate to what extent they feel negative emotions. The final score is the sum of the ten negative emotions/feelings. Higher scores indicate more negative affect.
Measured: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Emotion Regulation
Assessed using the Difficulties in Emotion Regulation Scale (DERS-16). Scores range from 0 to 64, with higher scores indicating more difficulties with emotion regulation.
Measured: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Alcohol Craving
Assessed using the Penn Alcohol Craving Scale (PACS). Scores range from 0 to 30, with higher scores indicating more craving.
Measured: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Percentage of Days Using Alcohol to Help With Sleep
Participants completed 2 weeks of sleep diaries assessing use of alcohol to help with sleep. Number of days reporting use of alcohol as a sleep aid was divided by the number of diaries completed to indicate the percentage of diary days they used alcohol as a sleep aid. Higher scores indicate more frequent use of alcohol as a sleep aid.
Measured: Primary analyses will measure between-group change at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Percentage of Days Using Sleep Medication
Participants completed 2 weeks of sleep diaries assessing use of sleep medication. Number of days reporting use of sleep medication was divided by the number of diaries completed to indicate the percentage of diary days they used a sleep medication. Higher scores indicate more frequent use of sleep medication.
Measured: Primary analyses will measure between-group change at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start4 Apr 2019
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Subjects will be randomized to receive sleep hygiene or to participate in sessions of individual Cognitive Behavioral Therapy for Insomnia (CBT-I).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Mary E Miller, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804788
- Sponsor's protocol ID
- 2014239
- Other IDs
- K23AA026895
- Acronym
- iTAP-V
- Status last verified
- Sep 2026
- First submitted
- 9 Jan 2019
- Last updated
- 11 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miller MB, Carpenter RW, Shoemaker SD, Moskal KR, Borsari B, Pedersen ER, Bartholow BD, Steinley D, McCrae CS. Cognitive behavioral therapy for insomnia among heavy-drinking veterans: a randomized pilot trial. Sleep Adv. 2025 Jun 10;6(2):zpaf037. doi: 10.1093/sleepadvances/zpaf037. eCollection 2025 Apr.
PubMed 40575624
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Insomnia Treatment on Heavy Alcohol Use Among Returning Veterans
- ClinicalTrials.gov ID
- NCT03804788
- Acronym / sponsor ID
- iTAP-V / 2014239
- Conditions
- Insomnia, Alcohol; Harmful Use
- Keywords
- alcohol, drinking, sleep, insomnia, veteran
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Posted 15 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.
Detailed description
More than half of returning Veterans who screen positive for hazardous drinking report clinically significant symptoms of insomnia. In turn, insomnia symptoms have been associated with increased risk of alcohol-related problems, perhaps due to insomnia-related impairments in executive functioning, negative emotionality, and craving. The proposed project aims to examine improvements in insomnia as a mechanism for improvement in alcohol use among heavy-drinking Veterans with insomnia. Forty-four returning Veterans who report heavy drinking (≥4/5 drinks per occasion for women/men) and have insomnia based on DSM-5 and research diagnostic criteria will participate in a randomized pilot trial. Participants will be randomly assigned to receive personalized normative alcohol feedback in the context of one of two treatment conditions: CBT-I (n = 22) or a sleep hygiene education control (SH; n = 22). Outcomes will be assessed at the end of the active intervention period (6 weeks), mid-treatment (after 3 sessions), and at 3 months post-intervention. Outcomes of interest include insomnia severity, total wake time, sleep quality, drinking quantity/frequency, alcohol-related consequences, executive functioning, negative affect, emotion regulation, craving for alcohol, and use of alcohol as a sleep aid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to receive sleep hygiene or to participate in sessions of individual Cognitive Behavioral Therapy for Insomnia (CBT-I).
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia, Behavioral: Sleep HygeineIndividual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for six (6) weeks. |
| Sleep Hygiene | Active comparator | Behavioral: Sleep HygeineSleep hygiene handout delivered once to all participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veteran deployed for military service after September 11, 2001
- 1+ heavy drinking episode (4/5+ drinks in 2 hours for women/men) in past 30 days
- DSM-5 and research diagnostic criteria for Insomnia Disorder
Key exclusion criteria (9 listed)
- Inability to provide informed consent
- Cognitive impairment
- Contraindications for CBT-I (mania or seizure disorder)
- Untreated sleep disorder requiring more than behavioral treatment for insomnia
- Engagement in overnight shift work at baseline
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 Behavioral Therapy for InsomniaAlso: (CBT-I)Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. A sixth week of treatment will be included - and scheduled for the same date as the post-treatment assessment - if the participant and research team agree that it would be beneficial (e.g., if a participant has difficulty grasping cognitive therapy concepts). Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring. | Behavioural | CBT-I |
| Sleep HygeineAll participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician. | Behavioural | CBT-I, Sleep Hygiene |
Primary outcome
Recruitment
Time frame: Assessed at baseline
Number of eligible participants who enrolled in the study
Retention
Time frame: Assessed at post-treatment (week 6)
Number of participants who complete all treatment sessions
Drinking Quantity
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Assessed using Daily Drinking Questionnaire. Participants report the number of standard drinks consumed on each day of a typical week in the past month (on Monday, Tuesday, Wednesday, etc). Responses for each day are then summed to calculate a total "drinks per week" variable, where higher scores indicate more standard drinks.
Alcohol-related Consequences
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Assessed using the Brief Young Adult Alcohol Consequences Questionnaire, which asks participants to indicate (yes/no) which of 24 consequences they have experienced in the past month. Responses range from 0 to 24, with greater scores indicating more consequences.
Insomnia Symptoms
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Assessed using Insomnia Severity Index (ISI). ISI scores from 0 to 28, with higher scores indicating more severe insomnia.
Sleep Quality
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
On daily sleep diaries, participants reported sleep quality on a scale from 0 (very poor) to 4 (very good). Higher scores indicate better sleep quality.
Sleep Efficiency
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Daily sleep diaries were used to calculate the amount of time that participants spent sleeping out of all the time they spent in bed. Values from 0 to 100, with higher scores indicating better sleep efficiency. The treatment goal is 85%.
Client Satisfaction
Time frame: Mean score at post-treatment (week 6).
Assessed using the 8-item Client Satisfaction Questionnaire. Participants rate their satisfaction with insomnia treatment on a scale from 1 (poor) to 4 (excellent). Scores were summed and then divided by the number of items to create a meaningful standardized score. Higher scores indicate greater satisfaction.
6 secondary outcomes
Delay Discounting
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Negative Affect
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Emotion Regulation
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Alcohol Craving
Time frame: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Percentage of Days Using Alcohol to Help With Sleep
Time frame: Primary analyses will measure between-group change at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Percentage of Days Using Sleep Medication
Time frame: Primary analyses will measure between-group change at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40575624Miller MB, Carpenter RW, Shoemaker SD, Moskal KR, Borsari B, Pedersen ER, Bartholow BD, Steinley D, McCrae CS. Cognitive behavioral therapy for insomnia among heavy-drinking veterans: a randomized pilot trial. Sleep Adv. 2025 Jun 10;6(2):zpaf037. doi: 10.1093/sleepadvances/zpaf037. eCollection 2025 Apr.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Behavioral Therapy for Insomnia and Sleep Hygeine in people with Insomnia and Alcohol; Harmful Use, run by University of Missouri-Columbia 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 11 Sep 2026. 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?
Yes. Results are posted in the registry (first posted 15 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recruitment (time frame: Assessed at baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03804788, which also lists 1 linked publication.
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 2026; AzTrials last refreshed its copy on 26 Oct 2026.