Web-based Self-help Intervention for Adolescents With Acute or Remitted Major Depressive Disorder

NCT04994470 | Completed

• 1 other identifier: 20114
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the feasibility and effectiveness of a web-based self-help intervention in adolescents with acute or remitted major depressive disorder. We will examine whether this intervention improves positive affect, reduces stress and alleviates negative affect and depressive symptoms in adolescents aged 12 to 18 years. We will also investigate the rates of adherence among the adolescents who use this web-based intervention and the acceptability of the intervention with adolescents.

Conditions

Depression; Depressive Disorder; Depressive Symptoms; Depressive Disorder, Major

Keywords

Depression; Adolescence; Youth; Web-based Intervention; Self-help; Positive Psychology; Depressive Symptoms; Treatment; Positive Thinking

Outcome Measures

Primary Outcomes (3)

• Beck Depression Inventory - Second Edition (BDI-II)

  The BDI-II is a self-report inventory to assess the severity of depressive symptoms, rated on a 4-point response scale, with higher scores indicating more severe depressive symptoms. Participants will complete the BDI-II at pre-, post-test and follow-up to determine change in depressive symptoms

  Pre-test (week 0), post-test (week 2), follow-up (week 4)

• Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)

  The PANAS is a self-report inventory to assess positive and negative affect (10 items for PA and 10 items for NA), rated on a 5-point response scale, with higher scores indicating more positive affect or negative affect. Participants will complete the PANAS at pre-, post-test and follow-up to determine change in negative and positive affect

  Pre-test (week 0), post-test (week 2), follow-up (week 4)

• Perceived Stress Scale (PSS-10)

  The PSS-10 is a self-report inventory to assess perceived stress, rated on a 5-point response scale, with higher scores indicating more perceived stress. Participants will complete the PSS-10 at pre-, post-test and follow-up to determine change in perceived stress.

  Pre-test (week 0), post-test (week 2), follow-up (week 4)

Secondary Outcomes (2)

• Adherence

  Post-test (week 2)

• Acceptance

  Post-test (week 2)

Study Arms (2)

Web-based intervention group

EXPERIMENTAL

Two-week web-based intervention

Behavioral: Two-week web-based self-help intervention based on principles of positive psychology

Web-based control group

SHAM COMPARATOR

Two-week web-based sham comparator

Behavioral: Two-week web-based text messages containing fun facts

Interventions

Two-week web-based self-help intervention based on principles of positive psychology BEHAVIORAL

The web-based self-help intervention consists of 14 exercises based on the following positive psychology domains: personal strengths, pleasure, gratitude, engagement (flow, mindfulness) and positive relationships. The (partly interactive) exercises are created to be implemented by the participants themselves without support of a therapist. Before starting the intervention, the participants are told that they will receive a daily email with an instruction for a short exercise over the period of two weeks. The participants are instructed to complete the exercises every day and are told that they will be asked to evaluate these exercises at the next appointment (post-test, week 2).

Web-based intervention group

Two-week web-based text messages containing fun facts BEHAVIORAL

The web-based sham comparator consists of 14 text messages containing random interesting facts ("fun facts"). Before starting the sham comparator, the participants are told that they will receive a daily email with a text message to read every over the period of two weeks. The participants are instructed to read these text messages every day and are told that they will be asked to evaluate these exercises at the next appointment (post-test, week 2).

Web-based control group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Current or remitted diagnosis of MD (ICD-10 diagnoses F32.0; F32.1; F32.2, F33.0, F33.1, F.33.2)
• Intelligence quotient (IQ) of ≥ 80

You may not qualify if:

• Acute suicidality
• Schizophrenic disorder
• Pervasive developmental disorder
• Bipolar disorder
• Borderline personality disorder
• Substance dependence disorder
• Insufficient knowledge of German

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Prof. Otto Beisheim Foundation: collaborator

Study Sites (1)

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich, Munich, Germany

Munich, Bavaria, 80336, Germany

Location

MeSH Terms

Conditions

Depression; Depressive Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Study Officials

• Gerd Schulte-Körne, Professor

  Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not aware of the assigned intervention group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher

Model Details: Participants are assigned to two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 6, 2021
• Study Start: January 4, 2021
• Primary Completion: May 2, 2022
• Study Completion: May 2, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)