- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07668843
MyPocketPal Feasibility Study
Feasibility and Acceptability of a Working Alliance-Informed Digital Mental Health App for University Students: A Pilot Randomized Controlled Trial
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Singapore, Singapur
- Nanyang Technological University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervention
The intervention group used an application whose design was guided by digital working alliance.
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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.
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Comparador activo: Control
The control group used a standard digital well-being resource available to students through the university's well-being office.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Perceived Usefulness, Attitude and Intention to Use from Technology Acceptance Model
Periodo de tiempo: Scores were collected prior to starting the study and at the end of the 4 week study during follow up.
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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.
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Changes in scores from Baseline in Digital Working Alliance Inventory at the end of 4 week intervention.
Periodo de tiempo: Scores were collected prior to starting the study and at the end of the 4 week study during follow up.
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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.
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Changes in scores from Baseline in Technological Self-Efficacy and Task Technology Fit at the end of 4 week intervention.
Periodo de tiempo: Scores were collected prior to starting the study and at the end of the 4 week study during follow up.
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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.
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Number of Logins Per Week
Periodo de tiempo: From enrollment to the end of treatment at 4 weeks
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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.
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From enrollment to the end of treatment at 4 weeks
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Number of Minutes Spent in the Application Per Week
Periodo de tiempo: From enrollment to the end of treatment at 4 weeks
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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.
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From enrollment to the end of treatment at 4 weeks
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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).
- Becker D. Acceptance of mobile mental health treatment applications. Procedia Computer Science. 2016;98:220-7.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IRB-2023-233
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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