Opp - a Universal Mental Health Promoting Mobile Application for Adolescents (Opp)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mental Health Wellness 1
• Intervention / Treatment: Device: Opp

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 Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henriette Kyrrestad, PhD; Phone Number: +47776233305; Email: henriette.kyrrestad@uit.no
• Study Contact Backup: Name: Sabine Kaiser, Phd; Email: sabine.kaiser@uit.no

Study Locations

• Norway
  • Tromsø, Norway
    • UiT The Arctic University of Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adolescents under 16 years whose guardians have given consent

Exclusion Criteria:

• severe developmental or cognitive challenges

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The waiting list control group will receive the intervention after study completion.
Experimental: Intervention group receiving 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).	Device: Opp; Opp is a universal mental health promoting mobile application for adolescents aged 13-25 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Tromso
• Collaborators: Norwegian Council for Mental Health; The Dam Foundation; Norwegian Directorate of Health
• Investigators: Principal Investigator: Henriette Kyrrestad, PhD, UiT The Arctic University of Norway

Publications and helpful links

Helpful Links

• Homepage

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): November 15, 2023
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; Coping; Mobile application; Mental health promotion
• Other Study ID Numbers: 279207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No