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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02265978
Other study ID # GOIPG/2013/450
Secondary ID
Status Completed
Phase N/A
First received October 7, 2014
Last updated July 8, 2015
Start date October 2014
Est. completion date May 2015

Study information

Verified date July 2015
Source University College Dublin
Contact n/a
Is FDA regulated No
Health authority Ireland: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

This study evaluates the effectiveness of a mental health mobile app (CopeSmart) in promoting positive mental health through emotional self-awareness in adolescents. Participants will be recruited from second-level schools in Ireland. Schools will be randomly assigned to the intervention or control condition. Participants in the intervention condition will use CopeSmart for a four week period. Those in the control condition will not use any mental health app.


Recruitment information / eligibility

Status Completed
Enrollment 387
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 14 Years to 19 Years
Eligibility Inclusion Criteria:

- Must be between 14 and 19 years

- Must be enrolled in second-level education

- Must have access to an iPhone, iTouch or Android mobile device

- Must obtain signed parental consent to participate

Exclusion Criteria:

- No parental consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms

  • General Mental Health and Well-Being

Intervention

Device:
CopeSmart
Participants will use the CopeSmart app at least once per day for four weeks

Locations

Country Name City State
Ireland University College Dublin Dublin

Sponsors (2)

Lead Sponsor Collaborator
University College Dublin Irish Research Council

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in levels of emotional self-awareness measured by the Emotional Self-Awareness Scale Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up) No
Secondary Changes in frequency of use of positive coping strategies measured by the Coping Strategies Inventory Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up) No
Secondary Changes in levels of well-being measured by the WHO-5 Well-Being Index Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up) No
Secondary Changes in help-seeking behaviour measured by the General Help-Seeking Questionnaire Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up) No
Secondary Changes in levels of emotional distress measured by the Depression, Anxiety and Stress Scale Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up) No

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