mHealth-supported Skills Training for Alcohol-Related Suicidality Phase 3
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
Suicide is a high priority public health problem and an increasingly prevalent alcohol-related consequence. One-third of people who die by suicide consume alcohol at hazardous rates in the year preceding death. Most people in an acute suicide crisis who present for treatment are admitted to acute psychiatric hospitalization. Yet, the 30-day period following discharge from hospitalization is by far the riskiest period for another suicide crisis. The specific aim for this project is to evaluate the feasibility and acceptability of an intervention called mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS). Thirty-five inpatients with suicidal thoughts or behaviors who misuse alcohol will be randomized to one of three study conditions -- mSTARS, treatment as usual, or treatment as usual with skills training.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18+
hospitalized for suicide crisis at Duke BHIP
an AUDIT-C score indicating hazardous past-month drinking (4 for men; 3 for women) + a 90-day calendar timeline follow-back (TLFB) indicating a minimum of 3 heavy drinking days per week on average (per NIAAA standards)
owns a smart phone
Disqualifiers
current psychotic or mania symptoms indicated by the MINI Neuropsychiatric Interview 6.0.(MINI)
receiving ECT at the time of hospitalization, which could inhibit learning
engaged in weekly outpatient psychotherapy
discharging to another high level of psychiatric care.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard inpatient psychiatric care
BehavioralAll participants involved in this study will receive standard of care treatment at Duke University Medical Center's Behavioral Health Inpatient Program.
Inpatient Skills Training
BehavioralInpatient skills training will be completed while participants are receiving inpatient treatment at BHIP. Skills training includes content designed to improve emotional regulation skills.
mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS)
BehavioralmSTARS includes inpatient skills training and a mobile health (mHealth) telephone app designed to encourage participants to apply skills acquired in inpatient skills training to real-life situations.
Treatment groups
35 Participants
are divided into 3 treatment groupsGroup A: mSTARSExperimental treatment 3 interventions
Group B: Treatment As UsualActive comparator 1 intervention
Group C: Treatment As Usual + Skills TrainingActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Number of participants who are recruited to participate
This is an indication of feasibility of being able to recruit enough participants in a timely manner into the protocol.
Time frame
30 days2
Number of participants who complete the post-treatment visit
Retention will be defined as the number of participants who complete the post-treatment visit that occurs 30 days post-discharge.
Time frame
30 days3
Number of participants who rate the intervention a 16 or more on the Client Satisfaction Questionnaire.
Acceptability of treatment will be measured by an 8-item measure designed to evaluate client satisfaction. Scores range from 8 to 32, with higher scores indicating higher satisfaction.
Time frame
30 days4
Number of participants who score above threshold (34 or more) on the mHealth Satisfaction Questionnaire
Acceptability of treatment will be measured by a 14-item measure designed to measure usability of mobile health apps. Scores range from 14 to 70. Higher scores indicate higher satisfaction.
Time frame
30 daysSecondary outcomes
1
Average score on the Beck Scale for Suicidal Ideation
Participants will complete the Beck Scale for Suicidal Ideation, a 19-item scale to assess ideation, plans, and/or intent to suicide. Scores range from 0 to 48, with higher scores indicating higher suicide risk.
Time frame
30 days2
Average score on the Beck Scale for Suicidal Ideation
Participants will complete the Beck Scale for Suicidal Ideation, a 19-item scale to assess ideation, plans, and/or intent to suicide. Scores range from 0 to 48, with higher scores indicating higher suicide risk.
Time frame
3-month follow-up3
Average number of drinking days
Patients will self-report the number of drinking days in the period between their post-treatment visit and the 3-month follow-up visit.
Time frame
30 days4
Average number of drinking days
Patients will self-report the number of drinking days in the period between their post-treatment visit and the 3-month follow-up visit.
Time frame
3-month follow-upLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: