Adapting a Telehealth Intervention for Suicide Prevention Among Patients With Alcohol Use Disorder in Tanzania (IDEAS-AUD)

March 12, 2026 updated by: Duke University

Adapting a Telehealth Intervention for Suicide Prevention Among Patients With Alcohol Use Disorder in Tanzania: IDEAS-AUD

Together, alcohol use and suicide account for approximately 4 million deaths per year, with a considerable burden on low and middle-income countries. Tanzania is among the world's most underserved nations for mental health treatment, with very little capacity to treat suicidality or alcohol use disorders. In this study, the researchers will adapt an evidence-based intervention for suicide prevention to address the unique needs of people with alcohol use disorders in Tanzania, and rigorously pilot test the intervention to assess its feasibility and acceptability in a Tanzanian emergency department.

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.

Detailed Description

Globally, alcohol use disorders (AUD) cause 3.3 million deaths each year and account for nearly 100 million disability-adjusted life years (DALYs). Alcohol use is also one of the most prominent risk factors for death by suicide, as people with AUD have a lifetime risk of suicide more than 7 times higher than the general population. In preliminary studies at Kilimanjaro Christian Medical Centre (KCMC) in Tanzania, 7% of patients with AUD met criteria for comorbid depression, 7% were experiencing suicidal thoughts or behavior, and nearly half reported challenges in social support. Unfortunately, Tanzania is also among the most underserved nations in the world for mental health treatment, with fewer than 1 psychologist or psychiatrist per 1 million people and very little capacity to intervene for suicide risk or AUD. Given this shortage in treatment, there is a critical need for innovative, resource-efficient treatments for suicide prevention among people with AUD. In Tanzania, 91% of the population owns a cellular phone and nearly 50% use mobile internet, yet telehealth interventions have been largely unexplored, representing a major missed opportunity for delivering evidence-based interventions. By adapting an evidence-based Motivational Interviewing intervention, MI-SafeCope, the team developed IDEAS for Hope, a telehealth intervention for suicide prevention in HIV care in Tanzania. In the current grant, the researchers propose to revisit this process by adapting MI-SafeCope, with lessons learned from the HIV study, to reduce suicide risk among people with AUD who are presenting for care in the KCMC Emergency Department (ED). The resulting intervention, IDEAS-AUD, will address suicide risk with a four-pillared approach: reducing alcohol-related harm, building social support, enhancing emotional health, and addressing social determinants of health. The pillars are integrated with Motivational Interviewing-enhanced safety planning and referral for local psychiatric care as appropriate. The long-term goal is to create evidence-based, accessible, and cost-effective treatments for mental health and substance use treatment in low-resource settings. The objectives of this proposal are to: 1) adapt IDEAS-AUD for the AUD population in Kilimanjaro, Tanzania; 2) rigorously evaluate the acceptability and feasibility of IDEAS-AUD; and 3) develop the intervention package, along with a trialability evaluation, for a future implementation evaluation and clinical trial. In Aim 1 of the current study, the researchers will identify drivers of suicide risk and desired intervention characteristics to prevent suicide in the AUD population at KCMC. In Aim 2, the study team will adapt an evidence-based suicide prevention intervention to existing AUD care, guided by a community coalition. In Aim 3, the investigators will pilot test the telehealth intervention to assess its feasibility and acceptability for reducing suicide risk in the KCMC AUD population. By the end of this proposed project, the researchers will have a framework-guided, culturally- and resource-adapted, piloted protocol for IDEAS-AUD, including screening tools, programmatic, and implementation components.

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.
30

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

No

Description

Inclusion Criteria:

  • 18 years of age or older
  • screen positive for alcohol use disorder (AUDIT >=8)
  • have had suicidal thinking (C-SSRS item indicating "actual thoughts of suicide") in last 30 days
  • clinically sober
  • medically stable
  • have the physical and cognitive capacity to provide consent and complete study procedures
  • able to communicate in Swahili or English

Exclusion Criteria:

  • prisoners
  • decline or unable to complete informed consent

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: IDEAS-AUD
3 sessions of telehealth-delivered counseling
Behavioral: IDEAS-AUD
Telehealth-delivered counseling to reduce suicide risk among people with Alcohol Use Disorder (AUD) who are presenting for care in the KCMC Emergency Department (ED).

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
Acceptability of intervention
Time Frame: 3 months
Acceptability of Intervention Measure (AIM). Four items scored from 1-Completely disagree to 5-Completely agree. Scores are summed for a total score of 4 to 20, with higher scores indicating greater acceptability.
3 months
Enrollment feasibility as measured by the percentage of ED patients with documented screening for study eligibility
Time Frame: up to 1 year
up to 1 year
Enrollment feasibility as measured by the number of eligible participants who declined enrollment
Time Frame: up to 1 year
up to 1 year
Enrollment feasibility as measured by the time needed to enroll 30 eligible participants
Time Frame: up to 1 year
up to 1 year
Retention feasibility as measured by the number of participants retained for follow-up
Time Frame: session 2 (2 weeks), session 3 (4 weeks), and 3 months
session 2 (2 weeks), session 3 (4 weeks), and 3 months

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.
Duke University

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.
Kilimanjaro Christian Medical Centre, Tanzania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brandon Knettel, PhD, Duke University

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.
August 1, 2027

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.
March 1, 2029

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.
March 1, 2029

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).
March 12, 2026

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.
March 12, 2026

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.
March 17, 2026

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.
March 17, 2026

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.
March 12, 2026

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.
March 1, 2026

More Information

Terms related to this study

Keywords

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.
  • Pro00118645

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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