Intervenciones Digitales para la Prevención de Recaídas en la Adolescencia (DigiTIFF)
Some adolescents experience periods of anxiety and/or depression, and some find that these periods return over time. The purpose of this study is to examine whether digital interventions-where individuals work systematically with their own thoughts and feelings during periods when they feel well-can help them maintain well-being for longer.
The study includes adolescents aged 16-19 who have previously experienced episodes of depression and/or anxiety to a degree that led them to seek help (e.g., from a school nurse, general practitioner, health clinic, or child and adolescent mental health service). Through a research app on their smartphones, participants complete tasks and answer questionnaires. The study is fully digital. Some participants meet with a therapist in digital group sessions, while others work independently with the digital content.
We will also examine the cost-benefit aspects of offering such interventions. If the study achieves its goals, digital interventions may eventually become a service offered to adolescents recovering from depression and anxiety.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ragnhild Bø, Ph.D.
- Número de teléfono: +47 41904595
- Correo electrónico: ragnhild.bo@psykologi.uio.no
Ubicaciones de estudio
-
-
-
Oslo, Noruega
- Reclutamiento
- University of Oslo
-
Contacto:
- Ragnhild Bø, PhD
- Número de teléfono: +47 41904595
- Correo electrónico: ragnhild.bo@psykologi.uio.no
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Currently in full or partial remission for a minimum of 2 months from a depressive disorder or an anxiety disorder as defined by self-reported scores on RCADS-47: previous episode(s) of t-score > 65 and current t-score =<65.
- Native or fluent Scandinavian language skills.
- Willingness to take part even when allocated to the non-preferred arm of the trial.
Exclusion Criteria:
- Ongoing depressive disorder, ongoing anxiety disorder as defined by current t-score =<65 on RCADS-47.
- Recent completion of one of the interventions in the two interventional arms.
- no available smartphone.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: App intervention
A transdiagnostic, self-guided CBT app:
|
A transdiagnostic, self-guided CBT app, called TankeVirus (literally translated Thought Viruses), consisting of three components:
|
|
Experimental: Group intervention
A transdiagnostic, mastery course for groups, delivered weekly in webinar format over three sessions. It includes videos and group discussions. |
Group-based webinar offering psychoeducation based on principles of CBT. |
|
Sin intervención: Assessment only
Only assessment will be conducted. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Relapse: Number of participants scoring above the diagnostic cut-off on the PHQ-9 modified for teens during the 12-month follow-up.
Periodo de tiempo: From enrollment to the end of follow-up at 12-months.
|
To use the PHQ-9 as a diagnostic aid for Major Depressive Disorder:
|
From enrollment to the end of follow-up at 12-months.
|
|
Time until relapse; reaching the diagnostic criteria of MDD according to PHQ-9 modified for teens
Periodo de tiempo: From enrollment to 12-months follow-up
|
Number of days until the diagnostic criteria of MDD as assessed PHQ-9 modified for teens has been reached. - Questions 1 and/or 2 need to be endorsed as a "2" or "3"
|
From enrollment to 12-months follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Repetitive negative thinking (RNT-10)
Periodo de tiempo: At enrollment, and at 3, 6 and 12 months follow-up
|
Assess transdiagnostic repetitive negative thinking |
At enrollment, and at 3, 6 and 12 months follow-up
|
|
Somatic complaints (SSS8)
Periodo de tiempo: At enrollment, and at 3, 6, and 12-months follow-up.
|
Somatic complaints based on sum score of all items |
At enrollment, and at 3, 6, and 12-months follow-up.
|
|
EPOCH Measure of Adolescent Well-Being
Periodo de tiempo: At baseline, 3, 6 and 12-months follow-up.
|
A 20-item validated questionnaire (4 items per domain; Engagement, Perseverance, Optimism, Connectedness, Happiness) on a 1-5 Likert scale (1=Almost Never, 5=Almost Always) resulting in domain scores, reflecting strengths in these positive psychological areas crucial for youth well-being. |
At baseline, 3, 6 and 12-months follow-up.
|
|
Health related quality of life
Periodo de tiempo: At baseline, 3, 6 and 12-months follow-up.
|
EQ-5D-5L will be used to assess five domains of patient reported outcomes and for economic evaluation of the interventions. |
At baseline, 3, 6 and 12-months follow-up.
|
|
Health related quality of life - Visual Analog Scale
Periodo de tiempo: At baseline, 3, 6 and 12-months follow-up.
|
EQ VAS will be used to assess patient reported outcomes for self-rated health and for economic evaluation of the interventions. |
At baseline, 3, 6 and 12-months follow-up.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Client satisfaction questionnaires (CSQ-I)
Periodo de tiempo: At 3 months follow-up.
|
The 8-item questionnaire assesses how satisfied the participants are with the interventions, only administrated to those who are in the interventional arms. |
At 3 months follow-up.
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 870757
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The dataset underlying the results will be shared together with publications.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .