Opp - a Universal Mental Health Promoting Mobile Application for Adolescents

Mental Health Wellness 1 Clinical Trial

— Opp  

Official title:

Opp: The Development and Evaluation of a Mental Health App for Adolescents

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05211713
• Other study ID #: 279207
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 1, 2030

Study information

• Verified date: December 2023
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the project is firstly, to develop an app-based mental health intervention for adolescents. Secondly, to evaluate the effect of this app. The overarching goal is to offer a low-threshold intervention, called Opp, that is easily accessible and free to use for all adolescents in Norway.

Description:

The intervention "Opp" will be delivered through a mobile application. The overall goals of Opp are to 1) increase well-being and mental well-being, 2) increase knowledge about mental health, 3) increase coping skills to deal with stress, 4) increase help-seeking behavior, 5) increase self-esteem, 6) increase sleep quality and 7) reduce mental health problems.

To evaluate the mobile application two studies will be conducted: A user survey and an effectiveness study with a follow-up examination after about six weeks. The effectiveness study will be conducted as a randomized controlled trial with an intervention group and a waiting-list control group.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: December 1, 2030
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

Inclusion Criteria:

• Adolescents under 16 years whose guardians have given consent

Exclusion Criteria:

• severe developmental or cognitive challenges

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

Device:
• Opp
Opp is a universal mental health promoting mobile application for adolescents aged 13-25 years.

Locations

Country	Name	City	State
Norway	UiT The Arctic University of Norway	Tromsø

Sponsors (4)

Lead Sponsor	Collaborator
University of Tromso	Norwegian Council for Mental Health, Norwegian Directorate of Health, The Dam Foundation

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in WHO-5 (WHO-Five Well-being Index)	WHO-5 (WHO, 1998): A five item self-report questionnaire assessing well-being on a six point scale.	Change from baseline to six weeks after intervention.
Primary	Change in SDQ (Strengths and Difficulties Questionnaire)	SDQ (Goodman, 1997): A 25 item self-report assessing mental health and psychosocial functioning in 11-17 years old adolescents on a three point scale.	Change from baseline to six weeks after intervention.
Secondary	General Self-efficacy scale (GSE)	Resilience will be measured with the Norwegian version of the GSE (Røysamb, 1997; Schwarzer et al., 1995) which consists of 10 questions measured on a four-point scale.	Change from baseline to six weeks after intervention.
Secondary	Help-seeking behavior	Two self-report items measuring if they sought help and who they sought help from.	Change from baseline to six weeks after intervention.
Secondary	Self-liking and Competence Scale	Self-liking and Competence Scale (Silvera, Neilands, & Perry, 2001; Tafarodi & Swann, 2001): A 20 item self-report assessing self-liking and self-competence.	Change from baseline to six weeks after intervention.
Secondary	Sleeping quality	Sleeping quality will be measured with six questions from the Bergen Child Study (Hysing, Harvey, Stormark, Pallesen, & Sivertsen, 2018).	Change from baseline to six weeks after intervention.

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