Efficacy and Cost Effectiveness of Internet-delivered Trauma-focused CBT for Young People With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale Children and Adolescent version 5 (CAPS-5-CA)
研究概览
简要总结
The goal of this clinical trial is to compare therapist-guided internet delivered trauma-focused cognitive behavior therapy (CBT) to an active control condition comprising therapist-guided internet delivered cognitive behavioral therapy containing relaxation techniques and psychoeducation for young people with post-traumatic stress disorder regarding efficacy and cost effectiveness.
Young people with post-traumatic stress disorder will be randomly assigned to receive either 12 weeks of therapist-guided internet delivered trauma-focused cognitive behavior therapy (iTF-CBT) or therapist-guided internet delivered cognitive-behavioral therapy containing relaxation and psychoeducation.
详细描述
There is an urgent need for evidence-based treatments for children with PTSD that can easily be made available to a large number of afflicted. The overall aim of the project is to increase the availability of evidence-based psychological treatments for adolescents with PTSD by developing and evaluating iTF-CBT for this target group. The main objectives are to establish the efficacy, cost-effectiveness, and long-term effects of iTF-CBT for adolescents with PTSD in an RCT (N=140) by comparing guided iTF-CBT with an attention control group consisting of therapist-supported internet-delivered psychoeducation and support.
The study is a single-blind, parallel-group superiority randomized controlled trial with 240 patients (120 per arm) that will compare therapist-guided internet delivered trauma-focused cognitive behavior CBT with therapist-guided internet delivered cognitive-behavioral therapy comprising relaxation and psychoeducation. The primary outcome is the blind-rater administered Clinician-Administered PTSD Scale for DSM-5 (CAPS-5-CA). An internal pilot is built in in the design and the first 20 enrolled participants will not be randomized but receive the active intervention. They will also be asked to participate in qualitative interviews about their experience of the intervention.
Secondary outcomes are cost effectiveness, predictors of clinically meaningful change in symptoms, mediators of change, dropout rate, and negative effects.
Research questions:
- Is guided iTF-CBT more efficacious than an active control condition (therapist-supported internet-delivered psychoeducation and support) in regard to reduction of blinded assessor rated PTSD symptom severity 1-month post-treatment?
- Is guided iTF-CBT more cost-effective than an active control condition (therapist-supported internet-delivered psychoeducation and support) in regard to reduction of blinded assessor rated PTSD symptom severity 1-month post-treatment?
- Are the therapeutic gains of iTF-CBT maintained at long term follow up (6 and 12 months after treatment)?
- How do children, parents and therapists perceive iTF-CBT?
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
Blinded assessors will be used.
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,
- •Primary PTSD diagnosis
- •Fluent in Swedish
- •Access to the Internet at home or can use vouchers for internet-access to their phone.
- •Parent/guardian willing and able to take part in treatment.
排除标准
- •PTSD is not the primary concern
- •Initiation or adjustment of any psychotropic medication within the last 4 weeks prior to commencement of treatment
- •Serious mental health symptoms, such as mania, psychosis, alcohol, or substance use disorders or current suicide risk warranting immediate clinical attention.
- •Ongoing trauma-focused CBT or Eye movement desensitization and reprocessing Therapy
- •Ongoing trauma-related threat
研究组 & 干预措施
Therapist-supported psychoeducation and stress management
Therapist-supported CBT internet-delivered treatment comprising psychoeducation about PTSD, relaxation/stress management techniques and relapse prevention. The treatment will be delivered in a digital platform for twelve weeks. Participants will have access to a therapist that will guide them through treatment in a text-based material as well as audio files and video illustrations in an age-appropriate manner that the participant gains access to sequentially.
干预措施: 12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver. (Behavioral)
Therapist-supported internet delivered trauma-focused CBT
Therapist-supported internet delivered trauma-focused CBT. The protocol mirrors the exact content of first-line treatment for children with PTSD but is delivered through a digital platform and will comprise of text-based material as well as audio files and video illustrations in an age-appropriate manner that the participant gains access to sequentially. iTF-CBT will be therapist-assisted, and each participant will have a designated therapist to guide them through treatment. Treatment will span over 12 weeks and integrates cognitive, behavioral, interpersonal, and family therapy principles as well as trauma interventions. Parallel to the child's treatment, the caregivers are provided the same components and parenting practices, and joint child-parent activities are included. Participants will have access to a therapist that will guide them through treatment in a text based format.
干预措施: Therapist-supported internet-delivered trauma-focused CBT (Behavioral)
结局指标
主要结局
Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale Children and Adolescent version 5 (CAPS-5-CA)
时间窗: Baseline, 1-month (primary endpoint), 6-month and 12-month after treatment completion
The CAPS-5-CA is a structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.
次要结局
- Change in self-rated symptoms of PTSD and complex PTSD measured by The Child and Adolescent Trauma Screen (CATS-2)(Baseline, through the treatment period up to 12 weeks and 1-month, 6-month and 12-month after treatment completion)
- Change in self-rated symptoms of depression as measured by Mood and Feelings Questionnaire (MFQ)(Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion)
- Adverse events related to treatment measured by the Negative effects questionnaire(Immediately after treatment completion, 1-month, 6-month and 12-month after treatment completion)
- Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).(Immediately after treatment completion.)
- Change in psychosocial impairment measured by The Education, Work and Social Adjustment Scale, Youth and Parent (EWSAS)(Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion)
- Quality of life measured by Assessment of Quality of Life KIDSCREEN-10(Immediately after treatment completion, 1-month, 6-month and 12-month after treatment completion)
- Number of messages sent and received in the digital platform(Baseline up to 12 weeks)
- Change in Treatment Inventory of Costs in Psychiatric Patients (TIC-P)(Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion)
- Number of completed treatment modules(Baseline up to 12 weeks)
- Number of home work assignments made by the participant during the treatment period(up to 12 weeks)
- Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews(up to the 6-month follow up)
- The proportion of participants that conducts the weekly measures and further assessment points(up to the 6 months follow up)
- The proportion of participants that go through the entire treatment period(up to 12 weeks)
- Number of drop-outs from treatment(up to 12 weeks)
研究者
Maria Bragesjo
PhD, clinical psychologist
Karolinska Institutet