NCT07668843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2024

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
Last Updated

June 25, 2026

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

June 16, 2026

Last Update Submit

June 21, 2026

Conditions

Keywords

Working AllianceDigital Mental Health AppUniversity Students

Outcome Measures

Primary Outcomes (5)

  • Perceived Usefulness, Attitude and Intention to Use from Technology Acceptance Model

    9 Items used to measure the Technology Acceptance Model constructs of Perceived Usefulness, Attitude and Intention to Use were adapted from were adapted from Klopping and McKinney (2004), Yu and Yu (2010), and Ahadzadeh, Sharif (2015). The measurements were taken utilizing a 7 point Likert scale where 1 represented Strongly Disagree and 7 represented Strongly Agree

    Scores were collected prior to starting the study and at the end of the 4 week study during follow up.

  • Changes in scores from Baseline in Digital Working Alliance Inventory at the end of 4 week intervention.

    6 Items used to measure the constructs of Shared Goals, Task Relevance, Bonds and Digital Working Alliance were adapted from Goldberd et al. (2022) The measurements were taken utilizing a 7 point Likert scale where 1 represented Strongly Disagree and 7 represented Strongly Agree

    Scores were collected prior to starting the study and at the end of the 4 week study during follow up.

  • Changes in scores from Baseline in Technological Self-Efficacy and Task Technology Fit at the end of 4 week intervention.

    6 Items measuring were used to measure the constructs of Technological Self-Efficacy and Task Technology Fit were adapted from Becker (2016). The measurements were taken utilizing a 7 point Likert scale where 1 represented Strongly Disagree and 7 represented Strongly Agree.

    Scores were collected prior to starting the study and at the end of the 4 week study during follow up.

  • Number of Logins Per Week

    Participants were advised to log in once per week. To track adherence, the number of logins to the application (where the application was launched and brought to the foreground) was collected. This data was collected automatically by the application. The value ranges from 0 to X where 0 represents no logins and X where X is an integer representing the number of logins and will be used to understand a participants weekly adherence and engagement.

    From enrollment to the end of treatment at 4 weeks

  • Number of Minutes Spent in the Application Per Week

    To track engagement, the number of minutes spent in the application was collected. Users were considered to be spending time in the application when the application was launched and in the foreground of the mobile device. This data was collected automatically by the application. The value ranges from 0 to X where 0 represents 0 minutes spent in the application and X is an integer representing the total number of minutes spent in the application, and will be used to understand a participant's weekly engagement.

    From enrollment to the end of treatment at 4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group used an application whose design was guided by digital working alliance.

Other: MyPocketPal

Control

ACTIVE COMPARATOR

The control group used a standard digital well-being resource available to students through the university's well-being office.

Other: Control

Interventions

The intervention app, MyPocketPal, is a digital mental health literacy application designed for university students and informed by the digital working alliance framework. The app aims to enhance mental health knowledge and engagement through personalized, contextually relevant content tailored to students' interests and experiences. It includes six modules covering mental health information, personal stories, self-help tools, wellness resources, support services, and additional resources. A virtual agent introduces weekly content and provides recommendations based on user preferences. Interactive features such as guided breathing exercises, meditation, journaling, and mental health screening tools are incorporated to promote engagement, while content is released progressively to reduce information overload and encourage sustained use.

Intervention
ControlOTHER

The control application consisted of a digital mental health resource that presented general well-being content commonly available to university students. Content included articles, infographics, videos, event listings, support contacts, and links to external mental health tools covering topics such as stress management, sleep hygiene, mindfulness, and overall well-being. Information was organized into browsable categories and updated regularly.

Control

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanyang Technological University

Singapore, Singapore

Location

Related Publications (5)

  • Ahadzadeh AS, Pahlevan Sharif S, Ong FS, Khong KW. Integrating health belief model and technology acceptance model: an investigation of health-related internet use. J Med Internet Res. 2015 Feb 19;17(2):e45. doi: 10.2196/jmir.3564.

    PMID: 25700481BACKGROUND
  • Yu TK, Yu TY. Modelling the factors that affect individuals' utilisation of online learning systems: An empirical study combining the task technology fit model with the theory of planned behaviour. British Journal of Educational Technology. 2010;41(6):1003-17.

    BACKGROUND
  • Klopping IM, McKinney E. Extending the technology acceptance model and the task-technology fit model to consumer e-commerce. Information Technology, Learning & Performance Journal. 2004;22(1).

    BACKGROUND
  • Goldberg SB, Baldwin SA, Riordan KM, Torous J, Dahl CJ, Davidson RJ, Hirshberg MJ. Alliance With an Unguided Smartphone App: Validation of the Digital Working Alliance Inventory. Assessment. 2022 Sep;29(6):1331-1345. doi: 10.1177/10731911211015310. Epub 2021 May 18.

    PMID: 34000843BACKGROUND
  • Becker D. Acceptance of mobile mental health treatment applications. Procedia Computer Science. 2016;98:220-7.

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 25, 2026

Study Start

March 24, 2024

Primary Completion

June 5, 2024

Study Completion

June 30, 2024

Last Updated

June 25, 2026

Record last verified: 2025-11

Locations