Alcohol Use DisorderNCT06487793
Mobile App Intervention for Sleep Problems and Alcohol Use Among Veterans
A study testing Enhanced Insomnia Coach and Sleep hygiene comparator in people with Alcohol Use Disorder and Insomnia, run by University of Southern California.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Insomnia
- What is being tested?
- Enhanced Insomnia Coach and Sleep hygiene comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- Positive screening for other substance use disorders (not including cannabis use disorder)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Alcohol Use Disorder, Insomnia
- Being tested
- Enhanced Insomnia Coach, Sleep hygiene comparator
- Medical subject headings
- Alcoholism, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Insomnia CoachBehavioural
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).
Sleep hygiene comparatorBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Insomnia Coach Mobile App Intervention | Experimental | 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. Receives: Behavioral: Enhanced Insomnia Coach |
| Sleep Hygiene Control | Active comparator | Participants assigned to the control condition are asked to view sleep hygiene modules delivered by email once per week for 8 weeks. Receives: Behavioral: Sleep hygiene comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia symptoms
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.
Measured: Past 30 days
Alcohol use frequency
Days used in past 30 days
Measured: Past 30 days
Alcohol use quantity
Number of drinks per drinking occasion
Measured: Past 30 days
Secondary outcomes (2)
Sleep quality
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)
Measured: Past 30 days
Alcohol-related consequences
15-item Short Inventory of Alcohol Problems assesses problems from alcohol use across multiple domains such as interpersonal, intrapersonal, and physical.
Measured: Past 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- RAND, Palo Alto Veterans Institute for Research, University of Missouri-Columbia
- Responsible party
- Principal investigator, Eric Pedersen, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487793
- Sponsor's protocol ID
- R34AA030868
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared in accordance with NIH guidelines and uploaded to the NDA repository.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile App to Address Co-Occurring Sleep Problems and Heavy Alcohol Use Among Veterans Outside of Care Settings
- ClinicalTrials.gov ID
- NCT06487793
- Acronym / sponsor ID
- R34AA030868
- Conditions
- Alcohol Use Disorder, Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- RAND, Palo Alto Veterans Institute for Research, University of Missouri-Columbia
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Jul 2024 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Insomnia Coach Mobile App Intervention | Experimental | Behavioral: Enhanced Insomnia CoachParticipants 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. |
| Sleep Hygiene Control | Active comparator | Behavioral: Sleep hygiene comparatorParticipants assigned to the control condition are asked to view sleep hygiene modules delivered by email once per week for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Positive screening for other substance use disorders (not including cannabis use disorder)
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 |
|---|---|---|
| Enhanced Insomnia CoachThe 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). | Behavioural | Enhanced Insomnia Coach Mobile App Intervention |
| Sleep hygiene comparatorContent 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. | Behavioural | Sleep Hygiene Control |
Primary outcome
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.
Alcohol use frequency
Time frame: Past 30 days
Days used in past 30 days
Alcohol use quantity
Time frame: Past 30 days
Number of drinks per drinking occasion
2 secondary outcomes
Sleep quality
Time frame: Past 30 days
Alcohol-related consequences
Time frame: Past 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: Undecided. Data will be shared in accordance with NIH guidelines and uploaded to the NDA repository.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Insomnia Coach and Sleep hygiene comparator in people with Alcohol Use Disorder and Insomnia, run by University of Southern California.
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 1 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: opening soon, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Pedersen ((323) 442-4046, Eric.Pedersen@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia symptoms (time frame: Past 30 days). The study lists 3 primary outcomes in all. 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 5 Jul 2024.