Mobile App Intervention for Sleep Problems and Alcohol Use Among Veterans

June 27, 2024 updated by: Eric Pedersen, University of Southern California

A Mobile App to Address Co-Occurring Sleep Problems and Heavy Alcohol Use Among Veterans Outside of Care Settings

The goal of this clinical trial is to test the preliminary efficacy of a brief mobile app targeting insomnia symptoms among veterans. In this study, we will enhance the mobile app, Insomnia Coach, with content from brief alcohol interventions to help veterans reduce both insomnia symptoms and alcohol use behaviors. We will compare those veterans who are randomly assigned to receive this brief mobile app intervention to those who receive a control condition. This will help us determine if veterans randomly assigned to receive the intervention experience greater improvement on outcomes compared to those who do not receive the intervention. The study involves a beta-test phase of the app to ensure feasibility and acceptability by veterans, followed by a randomized controlled trial with 130 veterans who meet criteria for insomnia and alcohol use disorder.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • U.S. veteran aged 18 or older separated or discharged from service in the Air Force, Army, Marine Corps, Navy, or Coast Guard
  • Not currently affiliated with active duty service or on active reserves or guard service
  • Served since September 11, 2001
  • No past 6-month treatment for alcohol or drug use or insomnia
  • Alcohol Use Disorder Identification Test (AUDIT) score of 8 or higher
  • Insomnia Severity Index (ISI) score of 10 or higher

Exclusion Criteria:

  • Positive screening for other substance use disorders (not including cannabis use disorder)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Enhanced Insomnia Coach Mobile App Intervention
Participants assigned to the experimental condition are asked to view the modules within the app for 8 weeks. The mobile app contains content based on cognitive behavioral therapy for insomnia (CBT-I) enhanced with content from brief alcohol interventions.
Behavioral: Enhanced Insomnia Coach
The intervention combines the Insomnia Coach app with additional brief alcohol intervention to facilitate behavior change for both drinking behavior and insomnia symptoms. Insomnia Coach contains multiple components of CBT-I (e.g., stimulus control, cognitive restructuring, relaxation training, sleep hygiene/psychoeducation, monitoring of sleep via journals). The brief alcohol intervention content added to the CBT-I app is based on CBT skills for moderate drinking, delivered in a motivational enhancement style, and has demonstrated efficacy among young adults and veterans (e.g., correcting perceived norms, use of protective behavioral strategies, challenging expectancies).
Active Comparator: Sleep Hygiene Control
Participants assigned to the control condition are asked to view sleep hygiene modules delivered by email once per week for 8 weeks.
Behavioral: Sleep hygiene comparator
Content is based on sleep hygiene practices, but without additional CBT-I content featured in the experimental condition. There is also not brief alcohol intervention content in the control condition.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Insomnia symptoms
Time Frame: Past 30 days
7-item Insomnia Severity Index (ISI). The ISI is a measure of insomnia symptoms including difficulty falling/staying asleep, sleep problems interfering with daily life, and concern about sleep problems.
Past 30 days
Alcohol use frequency
Time Frame: Past 30 days
Days used in past 30 days
Past 30 days
Alcohol use quantity
Time Frame: Past 30 days
Number of drinks per drinking occasion
Past 30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep quality
Time Frame: Past 30 days
The 19-item Pittsburgh Sleep Quality Index will assess nuanced sleep behaviors at each time point (e.g., sleep latency, sleep duration, subjective sleep quality)
Past 30 days
Alcohol-related consequences
Time Frame: Past 30 days
15-item Short Inventory of Alcohol Problems assesses problems from alcohol use across multiple domains such as interpersonal, intrapersonal, and physical.
Past 30 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment initiation
Time Frame: Past 30 days
Affirmative responses regarding whether participants initiated more formal treatment since starting the study
Past 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Missouri-Columbia
RAND
Palo Alto Veterans Institute for Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34AA030868 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be shared in accordance with NIH guidelines and uploaded to the NDA repository.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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