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| Name | Class |
|---|---|
| Bergen kommune | UNKNOWN |
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The goal of this randomized controlled trial is to investigate the effectiveness of a new therapist-guided rule based intervention in Bergen Municipality, Child and Family help center.
Do they have a decrease in anxiety symptoms following the intervention? Do they have an increase in functional level following the intervention?
Researchers will compare the therapist-guided rule based intervention with treatment as usual for adolescents with mild to moderate anxiety.
Participants will use the intervention, which is based on CBT, for 8 weeks.
Modi is a mobile application and consists of a training program for adolescents with anxiety problems. Anxiety is one of the most common mental disorders. The anxiety symptoms usually have an age of onset in adolescence. For many, these anxiety symptoms persist into adulthood, and lead to reduced quality of life and functional impairment. The goal is to prevent anxiety disorders, comorbid disorders and loss of function as a result of the anxiety symptoms.
This study wants to investigate the effectiveness of a digital intervention in a randomized controlled trial. The study will recruit N = 128 young people aged 13-16 who will be randomized to either a therapist-guided, rule-based chatbot intervention or treatment as usual in the Child and Family Help Center in Bergen Municipality. The study will examine the clinical effects of the new intervention compared to treatment as usual
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modi-application | Experimental | 8-weeks interventions provided by the mobile application Modi. Therapist-guided intervention |
|
| Treatment as usual | Active Comparator | The group will receive treatment as usual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modi | Other | The Modi course, an eight-week mobile application intervention for adolescents with anxiety symptoms, is based on cognitive therapy. Guided by a rule-based chatbot named "Anna," users navigate through predefined options and responses, learning about anxiety and recording their challenges. The app includes animated videos, illustrations, and audio files to enhance engagement. Modi consists of six chapters, with a focus on psychoeducation, the cognitive triangle, and exposure exercises. Participants receive guidance from two Modi therapists who provide weekly support via messages and scheduled phone calls, ensuring personalized assistance and addressing any issues throughout the course. |
| Measure | Description | Time Frame |
|---|---|---|
| Revised Child Anxiety and Depression Scale - 25 - Self-report | anxiety and depressive symptoms, higher score indicates worse outcomes | assessing change from screening, pre, week 2, week 4, week 6, and immediately after the intervention, follow-up 1 month, and at follow-up 6 months] |
| Revised Child Anxiety and Depression Scale - 25 - Parent-report | anxiety and depressive symptoms, higher score indicates worse outcomes | assessing change from screening, pre, week 2, week 4, week 6, and immediately after the intervention, follow-up 1 month, and at follow-up 6 months] |
| Measure | Description | Time Frame |
|---|---|---|
| Strengths and Difficulties Questionnaire - Youth version | The scale measure adolescent's general mental health, with a higher score indicating worse symptoms. The study intends to use all three components of the measurement, including 1) the basis of SDQ, which includes 25 items on psychological attributes, 2) impact supplement, measuring functional level. The follow-up version also includes two additional follow-up questions |
| Measure | Description | Time Frame |
|---|---|---|
| Motivation Questionnaire | assessments of their motivation to participate in the study and interventions, developed specifically for this study | week 2 |
| Evaluation Questionnaire | evaluation assessments of the Modi intervention, developed specifically for this study. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Smiti Kahlon, PhD | Contact | +4798866640 | smiti.kahlon@helse-bergen.no | |
| Tine Nordgreen, PhD | Contact | +4790094913 | tine.nordgreen@helse-bergen.no |
| Name | Affiliation | Role |
|---|---|---|
| Smiti Kahlon, PhD | Haukeland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research centre for digital mental health services, Haukeland University Hospital | Recruiting | Bergen | Vestland | 5009 | Norway |
The full protocol and informed consent forms are available upon request. The datasets and the statistical code will not be publicly available, but may be available upon reasonable request through correspondence with principal investigator and according to the Norwegian law and regulations.
starting after publication
PD will be made available from PI on reasonable request and according to relevant Norwegian laws and regulations
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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One group receives the digittal health intervention and one group receives treatment as usual
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A member of the research group will conduct the randomization
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| Treatment as usual | Other | Participants receive usual treatment at their local Child and Family Services. This treatment, known as Treatment as Usual (TAU), is not standardized but reflects the care they would receive in regular practice. It aligns with national clinical guidelines and includes individual therapy, parental counseling, and assessments. Typically, the treatment is provided by a therapist trained in cognitive behavioral therapy (CBT) or a psychologist |
|
| assessing change from screening, pre, week 4, immediately after the intervention, follow-up 1 month, and at follow-up 6 months] |
| Strengths and Difficulties Questionnaire - Parent version | The scale measure parent-reported adolescent's general mental health, with a higher score indicating worse symptoms. The study intends to use all three components of the measurement, including 1) the basis of SDQ, which includes 25 items on psychological attributes, 2) impact supplement, measuring functional level. The follow-up version also includes two additional follow-up questions | assessing change from screening, pre, week 4, immediately after the intervention, follow-up 1 month, and at follow-up 6 months] |
| immediately after the intervention |
| Qualitative interviews | Interviews with 15 adolescents from the Modi-group about their experience using the intervention | immediately after the intervention |
| demographics | gender, age | pre-intervention |