Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

MyPocketPal Feasibility Study

21 de junho de 2026 atualizado por: Nanyang Technological University

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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

70

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Singapore, Cingapura
        • Nanyang Technological University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Intervention
The intervention group used an application whose design was guided by digital working alliance.
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.
Comparador Ativo: Control
The control group used a standard digital well-being resource available to students through the university's well-being office.
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Perceived Usefulness, Attitude and Intention to Use from Technology Acceptance Model
Prazo: Scores were collected prior to starting the study and at the end of the 4 week study during follow up.

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

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

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
Prazo: From enrollment to the end of treatment at 4 weeks
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
Prazo: From enrollment to the end of treatment at 4 weeks
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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

24 de março de 2024

Conclusão Primária (Real)

5 de junho de 2024

Conclusão do estudo (Real)

30 de junho de 2024

Datas de inscrição no estudo

Enviado pela primeira vez

16 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de junho de 2026

Primeira postagem (Real)

25 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de junho de 2026

Última verificação

1 de novembro de 2025

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • IRB-2023-233

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever