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Clinical Trials/NCT07668843
NCT07668843CompletedNot Applicable

Feasibility and Acceptability of a Working Alliance-Informed Digital Mental Health App for University Students: A Pilot Randomized Controlled Trial

Nanyang Technological University1 site in 1 country70 target enrollmentStarted: March 24, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Locations
1

Study Overview

Brief Summary

Participants will take part in a 4-week study consisting of two in-person sessions. During the first session, participants will complete a demographic form and baseline questionnaire, after which the study application will be installed on their preferred device. A research team member will provide a brief introduction to the application, guide participants through the registration process, and schedule the second session. Participants will then be randomly assigned to one of two study conditions, with each group receiving a different version of the application's mental health content.

Over the following four weeks, participants may use the application freely and at their own discretion. The application will send weekly reminders based on participants' preferred day and time, but no further contact will be initiated by the research team unless participants require assistance or wish to withdraw. Depending on their assigned condition, participants will either access standard mental health content or content delivered through a virtual agent that introduces weekly themes and recommends resources based on individual interests. The application will automatically record user interactions, such as content viewed, duration of use, and navigation patterns, for research analysis.

At the end of the study period, participants will attend a second in-person session where they will complete a follow-up questionnaire and participate in a short semi-structured interview. The questionnaires and interview will assess participants' perceptions of the application, including therapeutic alliance, perceived usefulness, and intention to continue using it. The interview will also provide additional insights to help interpret participants' usage patterns and experiences with the application. Participants will receive compensation upon completion of the study.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
15 Years to 35 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age: Between 15 and 35 years of age.
  • Enrollment: Currently enrolled as students at a local university.
  • Language: Proficient in English.
  • Technology: Owned a smartphone capable of running the study application.

Exclusion Criteria

  • Age: Below 15 or above 35 years of age.
  • Enrollment: Not currently enrolled as students at a local university.
  • Language: Not proficient in English.
  • Technology: Does not own a smartphone capable of running the study application.

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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