Feasibility of Internet-delivered Cognitive Behavior Therapy for Adolescents With Mild to Moderate Depression: A Randomized Pilot Study Comparing Therapist-guided vs. 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
- 32
- 试验地点
- 2
- 主要终点
- Children's Depression Rating Scale - Revised (CDRS-R)
研究概览
简要总结
Prior to a properly powered randomized controlled study, evaluating efficacy and cost-effectiveness of ICBT, we will conduct a pilot study to investigate if the trial design is feasible, if therapist-guided and self-guided internet-delivered cognitive behavioral therapy (ICBT) is acceptable for adolescents with depression and to provide preliminary clinical efficacy data.
详细描述
A single-blind parallel-group pilot randomised controlled feasibility trial with the overall aim to develop two internet-delivered cognitive behaviour therapy interventions, therapist-guided and self-guided, for adolescents with mild to moderate Major Depressive Disorder (MDD) and their primary caregivers.
Patients can be either referred or self-referred. All potential participants are initially screened via telephone. This is followed by a face-to-face inclusion assessment. Participants who are eligible and have consented will be randomized into one of three trial arms; therapist-guided ICBT, self-guided ICBT or TAU. In the experimental arms, participants, e.g. the adolescent and at least one caregiver, either receive 10 weeks of therapist-guided or self-guided internet-delivered behavioural activation (BA). In the control arm, participants receive treatment as usual within the Child and Adolescent Mental Health Services (CAMHS) or primary care clinics. The primary endpoint will be at 3-month follow-up.
The primary objective is to evaluate the feasibility of the study design and trial procedures, including recruitment, withdrawal, drop out and attrition rates. The secondary objective is to (a) evaluate the acceptability of the ICBT interventions in regard to treatment satisfaction, credibility, reported adverse events, and program use, (b) to provide preliminary clinical efficacy data, and (c) to gather qualitative information on the experience of undergoing ICBT for depression from the perspective of adolescent patients, their caregivers and potential areas for improvement of future ICBT interventions.
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
- •Primary diagnosis of mild to moderate MDD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th ed.
- •Willing to be randomized to either of the three treatment arms.
- •Basic proficiency in Swedish, both adolescent and participating care-giver
- •Regular access to a desktop or laptop computer connected to the internet, as well as a mobile phone to receive sms (one of each is enough per family).
- •Stable medication with antidepressants, central stimulants and neuroleptics at least 6 weeks prior to inclusion.
- •A minimum of one caregiver that is able to co-participate in the treatment.
排除标准
- •Immediate risk to self or others, requiring urgent medical attention, such as suicidality, or repeated self-injurious behaviour.
- •Other severe psychiatric disorders requiring other actions at first hand (e.g. diagnosis of organic brain disorder, intellectual disability, psychosis, bipolar disorder, eating disorder, or alcohol/substance dependence;
- •Current social problems requiring other actions at first hand (e.g. bullying in school, abuse and/or neglect in the family; high and prolonged absence from school).
- •Previous CBT for MDD within the last 12 months prior to assessment, for a minimum of 3 sessions other than psychoeducation with a qualified therapist within the 12 months prior to assessment.
- •Current use of benzodiazepines.
- •An ongoing psychological treatment for any other psychiatric disorder.
结局指标
主要结局
Children's Depression Rating Scale - Revised (CDRS-R)
时间窗: week 0, week 10, at 3 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. Change from baseline in depressive symptom severity on the CDRS-R at end of treatment, and at 3-months follow-up will be reported. Primary endpoint is 3 months follow-up.
次要结局
- Need for further treatment - adolescent and parent version(week 10, at 3 months follow-up)
- Negative Effects Questionnaire (NEQ-20) - adolescent and parent version(week 5, week 10, at 3 months-follow up)
- Clinical Global Impression - Improvement (CGI-I)(week 10, at 3 months follow-up)
- Working Alliance Inventory, Short (WAI-S) - adolescent and parent version(week 10, 3 months follow-up)
- Treatment credibility and expectancy scale - adolescent and parent version(week 3)
- The Client Satisfaction Questionnaire-8 (CSQ-8) - adolescent and parent version(week 10, at 3 months follow-up)
- Treatment completion(week 10)
- Therapist time(week 1 to week 10)
- Clinical Global Impression Scale - Severity (CGI-S)(week 0, week 10, at 3 months follow-up)
- Children's global assessment scale (CGAS)(week 0, week 10, at 3 months follow-up)
- Work and Social Adjustment Scale, youth version (WSAS-Y) - adolescent and parent version(week 0, week 10, 3 months follow-up)
- Kidscreen-10 Index - adolescent and parent version(week 0, week 10, at 3 months follow-up)
- Short Mood and Feeling Questionnaire (SMFQ) - adolescent and parent version(week 0, weekly from week 1 to week 10, 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 months follow-up)
- Affective Reactivity Index (ARI) - adolescent and parent version(week 0, week 10, 3 months follow-up)
- Insomnia Severity Index (ISI)(week 0, week 10, at 3 months follow-up)
研究者
Eva Serlachius
PhD, MD
Karolinska Institutet