The Study of Internet-delivered, Transdiagnostic Treatments for Anxiety and Depression ("TRAnsdiagnostisk BEhandling (Elektronisk)")
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,477
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire 9-item scale (PHQ-9)
研究概览
简要总结
Anxiety and depression are common psychiatric disorders, resulting in suffering and impaired functioning for the individual. Today, most psychological treatments are disorder specific, even tough comorbidity between depression and anxiety and different anxiety disorders is rule rather than exception. Transdiagnostic treatments target the common features between depression and anxiety disorders and has shown to be as effective as disorder specific treatments in reducing symptoms of the disorders. Unified protocol and Affect phobia treatment are two types of transdiagnostic treatments that, to our knowledge, never been compared in research before. Internet-administered treatment presents a promising way to increase availability of psychotherapeutic interventions such as transdiagnostic treatments. However, questions regarding the optimal treatment length and level of support remain unanswered. The aim of this study is to examine two internet-administered transdiagnostic treatments and their effect on anxiety and depression, and to investigate the impact of treatment length and access to a moderated forum.
The study will investigate three factors: type of transdiagnostic treatment, length of treatment and whether patients have access to a moderated forum or not. 2400 participants with anxiety and/or depression will be randomly assigned to one of 12 subgroups and subsequently offered treatment based on differing combinations of the previously mentioned factors (200 participants/arm). The treatment conditions are internet-administered cognitive, behavioral treatment (CBT) Unified protocol and the psychodynamic Affect phobia treatment as well as a waitlist control group. Participants will also be randomized to either 8 or 16 weeks of treatment and access to a moderated forum or not.
Primary outcome measures will be the Patient Health Questionnaire, the Generalized Anxiety Disorder 7-item scale and the Brief Quality of Life scale. Negative effects of treatment will also be assessed. In addition to pre- and post-treatment measurements, the study includes one mid-treatment and three follow-up assessments (6, 12 and 24 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to read and write Swedish,
- •access to a mobile phone/computer,
- •18 years or older,
- •GAD-7 ≥ 5 and/or
- •PHQ-9 ≥ 10.
排除标准
- •Partaking in other psychological treatment,
- •has started or adjusted treatment with psychopharmacological drugs for anxiety, worry or depression within the nearest month,
- •severe depression (PHQ-9 ≥ 20) or suicidal (PHQ-9, item 9>2).
研究组 & 干预措施
CBT, 8 weeks and access to forum.
干预措施: Treatment condition: Internet-administered Unified protocol (Behavioral)
CBT, 8 weeks and access to forum.
干预措施: Treatment length: 8 weeks (Other)
CBT, 8 weeks and access to forum.
干预措施: Access to a moderated forum (Other)
CBT, 16 weeks and access to forum.
干预措施: Treatment condition: Internet-administered Unified protocol (Behavioral)
CBT, 16 weeks and access to forum.
干预措施: Treatment length: 16 weeks (Other)
CBT, 16 weeks and access to forum.
干预措施: No access to a moderated forum (Other)
CBT, 8 weeks and no access to forum.
干预措施: Treatment condition: Internet-administered Unified protocol (Behavioral)
CBT, 8 weeks and no access to forum.
干预措施: Treatment length: 8 weeks (Other)
CBT, 8 weeks and no access to forum.
干预措施: No access to a moderated forum (Other)
CBT, 16 weeks and no access to forum.
干预措施: Treatment condition: Internet-administered Unified protocol (Behavioral)
CBT, 16 weeks and no access to forum.
干预措施: Treatment length: 16 weeks (Other)
CBT, 16 weeks and no access to forum.
干预措施: Access to a moderated forum (Other)
Psychodynamic therapy, 8 weeks and access to forum.
干预措施: Treatment condition: Internet-administered Affect phobia treatment (Behavioral)
Psychodynamic therapy, 8 weeks and access to forum.
干预措施: Treatment length: 8 weeks (Other)
Psychodynamic therapy, 8 weeks and access to forum.
干预措施: Access to a moderated forum (Other)
Psychodynamic therapy, 16 weeks and no access to forum.
干预措施: Treatment condition: Internet-administered Affect phobia treatment (Behavioral)
Psychodynamic therapy, 16 weeks and no access to forum.
干预措施: Treatment length: 16 weeks (Other)
Psychodynamic therapy, 16 weeks and no access to forum.
干预措施: No access to a moderated forum (Other)
Psychodynamic therapy, 16 weeks and access to forum.
干预措施: Treatment condition: Internet-administered Affect phobia treatment (Behavioral)
Psychodynamic therapy, 16 weeks and access to forum.
干预措施: Treatment length: 16 weeks (Other)
Psychodynamic therapy, 16 weeks and access to forum.
干预措施: Access to a moderated forum (Other)
Psychodynamic therapy, 8 weeks and no access to forum.
干预措施: Treatment condition: Internet-administered Affect phobia treatment (Behavioral)
Psychodynamic therapy, 8 weeks and no access to forum.
干预措施: Treatment length: 8 weeks (Other)
Psychodynamic therapy, 8 weeks and no access to forum.
干预措施: No access to a moderated forum (Other)
Waitlist, 8 weeks and access to forum.
干预措施: Treatment condition: Waitlist control (Other)
Waitlist, 8 weeks and access to forum.
干预措施: Treatment length: 8 weeks (Other)
Waitlist, 8 weeks and access to forum.
干预措施: Access to a moderated forum (Other)
Waitlist, 16 weeks and access to forum.
干预措施: Treatment condition: Waitlist control (Other)
Waitlist, 16 weeks and access to forum.
干预措施: Treatment length: 16 weeks (Other)
Waitlist, 16 weeks and access to forum.
干预措施: Access to a moderated forum (Other)
Waitlist, 8 weeks and no access to forum.
干预措施: Treatment condition: Waitlist control (Other)
Waitlist, 8 weeks and no access to forum.
干预措施: Treatment length: 8 weeks (Other)
Waitlist, 8 weeks and no access to forum.
干预措施: No access to a moderated forum (Other)
Waitlist, 16 weeks and no access to forum.
干预措施: Treatment condition: Waitlist control (Other)
Waitlist, 16 weeks and no access to forum.
干预措施: Treatment length: 16 weeks (Other)
Waitlist, 16 weeks and no access to forum.
干预措施: No access to a moderated forum (Other)
结局指标
主要结局
Patient Health Questionnaire 9-item scale (PHQ-9)
时间窗: Through study completion, an average of 2 years.
The PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.
Brunnsviken Brief Quality of Life Scale (BBQ)
时间窗: Through study completion, an average of 2 years.
The BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.
Generalised Anxiety Disorder 7- item scale (GAD-7)
时间窗: Through study completion, an average of 2 years.
The GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.
次要结局
- Negative Effects Questionnaire (NEQ)(At post-treatment only (which is week 8 or 16 depending on treatment allocation).)
- The Personality Inventory for DSM Short Form (PID-5)(Baseline only.)
- Reflective Functioning Questionnaire 8 (RFQ-8)(Through study completion, an average of 2 years.)
研究者
Per Carlbring
Professor
Stockholm University