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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 2
- 主要终点
- Change from baseline in clinician-rated depressive scores on Children's Depression Rating Scale - Revised (CDRS-R)
研究概览
简要总结
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).
详细描述
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:
- To establish the 12-month durability of the treatment effects.
- 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).
- To investigate potential mediators behind a potential treatment effect of ICBT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors conducting post- and follow-up assessments will be blind to treatment allocation, for the full duration of the trial. The outcome measures are identical for both groups, ensuring that the assessors remain blind. At each follow-up assessment, participants will be reminded by their assessor to not reveal their arm allocation. To measure blinding integrity, all assessors will record whether the participating families inadvertently reveal their group allocation, and subsequently guess each participant's treatment allocation at each assessment point and motivate their choice. The blinding will be broken after the trial's final participant has finished his/her 3-month follow-up assessment (primary endpoint). The trial will end when the trial's final participant has finished his/her 3-month follow-up assessment.
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •13-17 years of age,
- •A diagnosis of mild to moderate MDD based on the DSM-5,
- •Willing to be randomized to either of the three treatment arms,
- •Basic proficiency in Swedish, both adolescent, and a participating caregiver
- •Regular access to a desktop, laptop computer connected to the internet, as well as a mobile phone,
- •If using medication with antidepressants, central stimulants, or neuroleptics it has to be unchanged at least 6 weeks prior to inclusion, and
- •A minimum of one caregiver that is able to co-participate in the treatment.
排除标准
- •The presence of psychiatric problems requiring immediate treatment (e.g., high risk of suicide, psychosis, severe self-injury, bipolar disorder, clinical eating disorder, alcohol/substance abuse),
- •Social problems requiring immediate action (e.g., ongoing abuse in the family, high and prolonged absence from school);
- •Previous psychological treatment for MDD (CBT, interpersonal psychotherapy (IPT), or BA) for a minimum of at least 3 sessions within the last 12 months prior to assessment.
- •Current use of benzodiazepines.
- •Ongoing psychological treatment for any psychiatric disorder.
研究组 & 干预措施
Guided ICBT
Participants in guided ICBT will receive internet-delivered CBT with therapist support. The treatment consists of 8 online modules with interactive features such as videos and illustrations, delivered over a maximum of 10 weeks. The main treatment focus is behavioral activation. The adolescent and the caregiver are provided with their own separate programs and login to the treatment platform. The caregiver's program also consists of 8 chapters, including psychoeducation about depression and how to support their adolescent in treatment. The adolescents and caregivers have regular contact with a personal assigned therapist via written text messages in the platform. Participants are typically in contact with their therapist several times a week. The adolescent and caregiver can continue to access all treatment modules for the whole follow-up period (3 months), but without therapist-support.
干预措施: Behavioral activation (BA) (Behavioral)
Self-guided ICBT
The self-guided arm is identical to the guided arm, however without the therapist support. To ensure patient safety, there will be clear instructions to the patients and primary caregivers on how to get in contact with the study team in case of acute problems, and there will be clinical routines to detect and manage deterioration or suicidal tendencies.
干预措施: Behavioral activation (BA) (Behavioral)
Treatment as usual (TAU)
Participants randomized to TAU, will be referred to the local CAMH's or primary care unit for children and youths and will be free to receive any treatment, either psychosocial, medical, or a combination of both. The content of TAU and the treatment techniques used will be monitored.
干预措施: Regular care within primary or secondary mental health care for children (Other)
结局指标
主要结局
Change from baseline in clinician-rated depressive scores on Children's Depression Rating Scale - Revised (CDRS-R)
时间窗: week 0, week 10, at 3 and 12 months follow-up
CDRS-R is a semi-structured clinician interview, assessing level of depressive symptomatology. Total range is 17-113, with higher values representing a worse outcome.
次要结局
- Internet Intervention Patient Adherence Scale (iiPAS)(Week 10)
- Affective Reactivity Index (ARI)(week 0, week 10, at 3 and 12 months follow-up)
- Clinical Global Impression Scale - Severity (CGI-S)(week 0, week 10, at 3 and 12 months follow-up)
- Children's global assessment scale (CGAS)(week 0, week 10, at 3 and 12 months follow-up)
- The Client Satisfaction Questionnaire-8 (CSQ-8) - adolescent and parent version(week 10)
- Insomnia Severity Index (ISI)(week 0, week 10, and at 3- and 12 months follow-up)
- Anhedonia Scale for Adolescents (ASA)(week 0, week 10, at 3 and 12 months follow-up)
- Behavioral activation of Depression Scale - short form (BADS-S)(week 0, weekly during treatment (week 1 to week 10), at 3- and 12 months follow-up)
- Work and Social Adjustment Scale, youth version (WSAS-Y) - adolescent and parent version(week 0, week 10, 3- and 12 months follow-up)
- Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)(week 0, week 10, at 3- and 12 months follow-up)
- Clinical Global Impression - Improvement (CGI-I)(week 10, at 3- and 12 months follow-up)
- Concomitant interventions(Week 10 and 3- and 12-months follow-up assessments.)
- Kidscreen-10 Index - adolescent and parent version(week 0, week 10, at 3- and 12-months follow-up)
- The Expressed Emotion Adjective Checklist (EEAC)(week 0, week 10, 3- and 12 months follow-up)
- Need for further treatment - adolescent and parent version(at 3 months follow-up)
- The Revised Children's Anxiety and Depression Scale, short (RCADS-S) -adolescent and parent version(week 0, week 10, 3- and 12 months follow-up)
- Treatment credibility - adolescent and parent version(week 3)
- Negative Effects Questionnaire (NEQ-20) - adolescent and parent version(Week 10 and 3 months follow-up)
- Quick Inventory of Depressive Symptomatology, 17 items (QIDS-17) - adolescent and parent version(week 0, weekly from week 1 to week 10, at 3- and 12 months follow-up)