The iTAP Study for Veterans

Insomnia Clinical Trial

— iTAP-V  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03804788
• Other study ID #: 2014239
• Secondary ID: K23AA026895
• Status: Completed
• Phase: N/A
• Start date: April 4, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2024
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Alcohol; Harmful Use
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Insomnia
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 Hygeine
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.

Locations

Country	Name	City	State
United States	University of Missouri-Columbia	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Number of participants who complete baseline assessment	Assessed at post-treatment (weeks 7-8)
Primary	Retention	Number of participants who complete all treatment sessions	Assessed at post-treatment (weeks 7-8)
Primary	Drinking quantity	Assessed using Timeline Followback and Daily Drinking Questionnaire	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Primary	Alcohol-related consequences	Assessed using the Brief Young Adult Alcohol Consequences Questionnaire	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Primary	Insomnia symptoms	Assessed using Insomnia Severity Index (ISI); ISI evaluates self-reports of insomnia experiences	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Primary	Sleep quality	Assessed using daily sleep diaries	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Primary	Sleep efficiency	Assessed using daily sleep diaries and actigraphy	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Primary	Client satisfaction	Assessed using the Client Satisfaction Questionnaire	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Secondary	Working memory updating	Assessed using the Keep Track task as described by Friedman et al (2008).	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Secondary	Working memory updating	Assessed using the N-Back Task as described in Jaeggi et al (2010).	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Secondary	Working memory updating	Assessed using the Letter Memory task as described in Miyake & Friedman (2012)	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Secondary	Response inhibition	Assessed using the Stop Signal task	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Secondary	Self-reported executive function	Assessed using the Behavior Rating Inventory of Executive Function of Adults	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Secondary	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; see Kirby, Petry, & Bickel, 1999). Higher k values indicate a greater preference for smaller, immediate rewards over larger, delayed reward.	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Secondary	Delay discounting	Assessed using the 5-trial delay discounting task	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Secondary	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.	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Secondary	Emotion regulation	Assessed using the Difficulties in Emotion Regulation Scale (DERS-16). The DERS-16 is a shortened version of the DERS scale. It measures emotion dysregulation based on subscales of clarity, goals, strategies, impulses, and non-acceptance.	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Secondary	Alcohol craving	Assessed using the Penn Alcohol Craving Scale (PACS); PACS evaluates thoughts about drinking by assessing the duration, frequency, and intensity of such thoughts.	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Secondary	Use of alcohol to help with sleep	Assessed using daily sleep diaries	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Secondary	Use of sleep medication	Assessed using daily sleep diaries	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Secondary	Autonomic arousal	Assessed using holter monitoring devices that provide a physiological index of arousal in the autonomic nervous system.	Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)