Opp - a Universal Mental Health Promoting Mobile Application for Adolescents

Not Applicable

Active, not recruiting

• Conditions: Mental Health Wellness 1
• Interventions: Device: Opp

• Registration Number: NCT05211713
• Lead Sponsor: University of Tromso

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-27
• Study Start: 2022-08-01
• Primary Completion: 2023-11-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-15
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Adolescents under 16 years whose guardians have given consent

Exclusion Criteria

• severe developmental or cognitive challenges

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group receiving Opp	Opp	The effectiveness study will be conducted as a randomized controlled trial with an intervention group and a waiting-list control group. Data will be collected at baseline (T1, pre intervention) and after about six weeks of intervention (T2, post intervention).

Primary Outcome Measures

Name	Time	Method
Change in WHO-5 (WHO-Five Well-being Index)	Change from baseline to six weeks after intervention.	WHO-5 (WHO, 1998): A five item self-report questionnaire assessing well-being on a six point scale.
Change in SDQ (Strengths and Difficulties Questionnaire)	Change from baseline to six weeks after intervention.	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.

Secondary Outcome Measures

Name	Time	Method
General Self-efficacy scale (GSE)	Change from baseline to six weeks after intervention.	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.
Help-seeking behavior	Change from baseline to six weeks after intervention.	Two self-report items measuring if they sought help and who they sought help from.
Sleeping quality	Change from baseline to six weeks after intervention.	Sleeping quality will be measured with six questions from the Bergen Child Study (Hysing, Harvey, Stormark, Pallesen, \& Sivertsen, 2018).
Self-liking and Competence Scale	Change from baseline to six weeks after intervention.	Self-liking and Competence Scale (Silvera, Neilands, \& Perry, 2001; Tafarodi \& Swann, 2001): A 20 item self-report assessing self-liking and self-competence.

Trial Locations

Locations (1)

UiT The Arctic University of Norway; 🇳🇴 Tromsø, Norway