The Insomnia Treatment and Problems Study for Veterans

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

Trial locations and contacts

1 site in 1 country.

About this study

Official title: The Impact of Insomnia Treatment on Heavy Alcohol Use Among Returning Veterans

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Recruitment

   Number of eligible participants who enrolled in the study

   Measured: Assessed at baseline

2. Retention

   Number of participants who complete all treatment sessions

   Measured: Assessed at post-treatment (week 6)

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted15 Jan 2019
2. Study start4 Apr 2019
3. Primary completion30 Sep 2023
4. 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.