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Active Elements of Digital Single-session Interventions - Trial NCT06322849

Access comprehensive clinical trial information for NCT06322849 through Pure Global AI's free database. This phase not specified trial is sponsored by Northwestern University and is currently Recruitment Completed. The study focuses on Depression. Target enrollment is 887 participants.

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NCT06322849
Recruitment Completed
behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT06322849
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Active Elements of Digital Single-session Interventions
Factorial Trial Designed to Identify Active Elements of a Self-administered Digital Single-session Intervention Targeting Depressive Symptoms.

Study Focus

Depression

Psychoeducation

Interventional

behavioral

Sponsor & Location

Northwestern University

Chicago, United States of America

Timeline & Enrollment

N/A

May 02, 2024

Jun 01, 2024

887 participants

Primary Outcome

Patient Health Questionnaire-8

Summary

Depression is a leading cause of disability in young adults. However, access to care is
 limited due to structural and psychological barriers. Single-session interventions (SSIs) are
 structured programs designed to maximize the therapeutic output in one interaction between
 the patient and the provider or a program. Project ABC, a single-session intervention (SSI),
 has been shown to be effective in reducing depressive symptoms. Project ABC is based on four
 components-psychoeducation, testimonials, saying is believing exercises, and action planning.
 However, it is unclear what are the effects of the individual components.
 
 The primary aim of this study is to calculate the main effects of the candidate
 components-psychoeducation, testimonials + saying is believing exercises, and action
 planning-on Patient Health Questionnaire-8 (PHQ-8) scores at 8-week follow-up.
 
 The secondary aims of this study are to:
 
 1. calculate the main effects of the candidate components-psychoeducation, testimonials +
 saying is believing exercises, and action planning-on PHQ-8 scores at immediate
 post-treatment and 2-week follow-up.
 
 2. calculate the interaction effects, if any, among the candidate components on PHQ-8
 scores at immediate post-treatment, 2-week, and 8-week follow-up.
 
 3. calculate the main and interaction effects of the candidate components on measures of
 hopelessness, autonomy, relatedness, and competence.
 
 4. determine if the effects of the candidate components on PHQ-8 are mediated by measures
 of autonomy, relatedness, and competence.
 
 Additionally, the exploratory aim of this study is to determine if common factors, like
 credibility of the intervention and expectations to improve, can lead to symptom change.

ICD-10 Classifications

Depressive episode
Other depressive episodes
Recurrent depressive disorder
Recurrent depressive disorder, unspecified
Post-schizophrenic depression

Data Source

ClinicalTrials.gov

NCT06322849

Non-Device Trial