Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
研究概览
简要总结
Background: Studies show that about 1 out of 3 patients in Primary Care suffer primarily from mental health disorders, such as anxiety disorders and depression. Cognitive behavior therapy (CBT) has been shown to be an effective treatment of these disorders. Despite the strong evidence for CBT there is a lack of evidence-based psychological treatment in primary care. For various reasons, the progress of research has not affected clinical practice. For successful implementation of CBT in primary care cost-effective therapies, access to therapists with proper training and supervision, evidence-based manuals and management that support the implementation is needed.
Aim: The aim of this trial is to evaluate a stepped care model with CBT in primary care. All patients are first treated with self-help CBT (N = 400). Patients that do not improve after treatment (9 weeks) are randomized to individual CBT or continued self-help treatment. Based on published studies 2/3 is expected to be improved after self-help and therefore do not undergo randomization. 1/3 (n = 133) who didn´t respond to treatment is randomized to individual CBT (N = 67) or continued self-help treatment (N = 67).
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have an anxiety disorder diagnosis (obsessive compulsive disorder, social phobia, panic disorder, generalized anxiety disorder), or/and major depression, or/and maladaptive stress reaction, or/and primary insomnia Clinician severity rating scale 2-6
排除标准
- •A higher score than 6 on the Clinician severity rating scale
研究组 & 干预措施
Continued guided self help CBT
Continued guided self help CBT. Participants will receive CBT through self-help books with minimal therapist contact (3 sessions in total).
干预措施: Continued self help CBT (Behavioral)
CBT individual therapy
After the initial face of self help CBT, patients in this arm receive individual CBT. The cognitive behavior therapy used in the study will be based on the protocols with best empirical support.The therapy is delivered by the same psychologist as in the first face and the second face builds on the learning's from the first face.
干预措施: Individual CBT (Behavioral)
结局指标
主要结局
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
时间窗: 52 weeks
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
时间窗: 9 weeks
Absolute improvement, i.e., symptom level below pre-established cut-offs at 9 weeks, 20 weeks, 26 week follow-up, and 52 week follow-up compared to baseline.
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
时间窗: 20 weeks
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
时间窗: 26 weeks
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
次要结局
- EuroQol-5 dimension (EQ5D)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Self-rated health 5 (SRH-5)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Obsessive Compulsive Inventory-Revised (OCI-R)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Panic Disorder Severity Scale Self-rated (PDSS-SR)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Health Anxiety Inventory (HAI)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Quality of Life Inventory (QOLI)(Baseline, post-treatment (20 weeks), 26 feel follow-up, 52 week follow-up)
- Sheehan Disability Scales (SDS)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Liebowitz Social Anxiety Scale Self-report (LSAS-SR)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Penn-State Worry Questionnaire (PSWQ)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Work ability index (WAI)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Insomnia Severity Index (ISI)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Perceived Stress Scale (PSS)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
研究者
Erik Hedman
Principal investigator
Karolinska Institutet