Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT04977856
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-06
First Post:
2021-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Cost-effectiveness of Internet-delivered CBT for Adolescents with Depression
Sponsor:
Region Stockholm
Organization:
Study Overview
Official Title:
Efficacy and Cost-effectiveness of Internet-delivered Cognitive Behavior Therapy for Adolescents with Mild to Moderate Depression: a Randomized Controlled Trial of Guided and Self-guided ICBT Vs. Treatment As Usual
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDA
Brief Summary:
Adolescent depression is a prevalent and impairing condition that can be effectively treated with Cognitive Behavior Therapy (CBT). However, a majority of adolescents do not have access to CBT. Internet-delivered CBT (ICBT) has been suggested as a way to increase availability to effective psychological treatments. Yet, the research on ICBT for adolescents has been lagging behind significantly.
The overall aim of this research project is to increase the availability of evidence-based psychological treatments for adolescents with depression by developing and evaluating internet-delivered Cognitive Behavior Therapy (ICBT) for this target group. The main objectives are to establish the efficacy, cost-effectiveness, and long-term effects of the guided and self-guided ICBT for adolescents with mild to moderate depression in a randomized controlled trial (RCT) with three-arms; guided ICBT (with therapist-support) and self-guided ICBT (without therapist-support) vs treatment as usual (TAU).
The overall aim of this research project is to increase the availability of evidence-based psychological treatments for adolescents with depression by developing and evaluating internet-delivered Cognitive Behavior Therapy (ICBT) for this target group. The main objectives are to establish the efficacy, cost-effectiveness, and long-term effects of the guided and self-guided ICBT for adolescents with mild to moderate depression in a randomized controlled trial (RCT) with three-arms; guided ICBT (with therapist-support) and self-guided ICBT (without therapist-support) vs treatment as usual (TAU).
Detailed Description:
Primary and secondary objectives
Primary objective:
1\. To determine the clinical efficacy of Guided and Self-guided ICBT for depression for reducing depressive symptom severity (as measured by the CDRS-R (27) in adolescents with mild and moderate major depressive disorder (MDD), compared with an active control intervention (treatment as usual within primary or secondary child and adolescent mental health care). The primary endpoint is the follow-up 3 months post-treatment.
Secondary objectives:
1. To establish the 12-month durability of the treatment effects.
2. To conduct a health-economic evaluation of guided ICBT for depression and self-guided ICBT for depression, compared with TAU, from multiple perspectives, both in the short term (primary endpoint) and the long term (12-month follow-up).
3. To investigate potential mediators behind a potential treatment effect of ICBT.
Research questions:
1. Is guided and self-guided ICBT more efficacious than TAU in regard to the reduction of depressive symptoms?
2. Is guided and self-guided ICBT more cost-effective than TAU?
3. Is self-guided ICBT more cost-effective than guided ICBT?
4. Are the therapeutic gains of ICBT maintained long term (i.e., 1 year after the intervention)?
5. Do changes in activation and avoidance (BADS) mediate changes at post-treatment in self-reported depressive symptoms (QIDS-A-17) in adolescents receiving ICBT (with or without therapist support), but not in the control group (treatment as usual)?
Primary objective:
1\. To determine the clinical efficacy of Guided and Self-guided ICBT for depression for reducing depressive symptom severity (as measured by the CDRS-R (27) in adolescents with mild and moderate major depressive disorder (MDD), compared with an active control intervention (treatment as usual within primary or secondary child and adolescent mental health care). The primary endpoint is the follow-up 3 months post-treatment.
Secondary objectives:
1. To establish the 12-month durability of the treatment effects.
2. To conduct a health-economic evaluation of guided ICBT for depression and self-guided ICBT for depression, compared with TAU, from multiple perspectives, both in the short term (primary endpoint) and the long term (12-month follow-up).
3. To investigate potential mediators behind a potential treatment effect of ICBT.
Research questions:
1. Is guided and self-guided ICBT more efficacious than TAU in regard to the reduction of depressive symptoms?
2. Is guided and self-guided ICBT more cost-effective than TAU?
3. Is self-guided ICBT more cost-effective than guided ICBT?
4. Are the therapeutic gains of ICBT maintained long term (i.e., 1 year after the intervention)?
5. Do changes in activation and avoidance (BADS) mediate changes at post-treatment in self-reported depressive symptoms (QIDS-A-17) in adolescents receiving ICBT (with or without therapist support), but not in the control group (treatment as usual)?
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: