Efficacy, Prediction and Methodological Evaluation of Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression: a Multicenter, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- changes of The Hamilton Depression Scale (HAMD-17)
研究概览
简要总结
This trial attempts to evaluate the treatment efficacy of Simplified Cognitive Behavioral Therapy (SCBT) and its safety among schizophrenia patients. Half of participants will be randomized to accept SCBT.
详细描述
The investigators have developed a simplified but standardized set of cognitive behavioral treatment (including the therapist's manual and patient self-help manual) for the patients of generalized anxiety disorder and depression, known as Simplified Cognitive Behavioral Therapy (SCBT). SCBT is the main psychological intervention of this study. The aim of this study is to verify its efficacy and applicability using a multi-center, randomized, placebo controlled and single-blind design, and to optimize the treatment program. The investigators hypothesize that SCBT is effective in patients with depression or anxiety, and the manual is easily-operated for the therapists.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-60 years old, male and female;
- •With primary school or above education levels;
- •Without vision, hearing or communication difficulties;
- •DSM-V diagnosis of generalized anxiety disorder and/or major depressive disorder;
- •HAMA-14 score greater than or equal to 14 points, less than 29 pionts; HAMD-17 score greater than or equal to 7 points, less than 24 points;
- •GAD-7 score greater than or equal to 5 points; PHQ-9 score greater than or equal to 5 points;
- •In the last 2 months, did not accept other forms of psychological treatment, or treatment is ineffective;
- •Voluntarily participate in and sign informed consent.
排除标准
- •Suffering from serious physical illness;
- •Having self-injurious behavior, suicidal tendencies;
- •Having bipolar disorder;
- •Having psychotic symptoms;
- •Having obsessive-compulsive disorder, post-traumatic stress disorder;
- •Pregnant women or lactating women.
研究组 & 干预措施
SCBT + Drug
Participants receive SCBT at a frequency of twice a week in the first 4 weeks, and once a week in the following 4 weeks. They also take SSRIs and/or SNRIs through the trial at a recommended dosage.
干预措施: SCBT (Behavioral)
SCBT + Drug
Participants receive SCBT at a frequency of twice a week in the first 4 weeks, and once a week in the following 4 weeks. They also take SSRIs and/or SNRIs through the trial at a recommended dosage.
干预措施: SSRIs and/or SNRIs (Drug)
Psychological Placebo + Drug
Participants receive supportive and relaxation therapy at a frequency of twice a week in the first 4 weeks, and once a week in the following 4 weeks. They also take SSRIs and/or SNRIs through the trial at a recommended dosage.
干预措施: SSRIs and/or SNRIs (Drug)
Psychological Placebo + Drug
Participants receive supportive and relaxation therapy at a frequency of twice a week in the first 4 weeks, and once a week in the following 4 weeks. They also take SSRIs and/or SNRIs through the trial at a recommended dosage.
干预措施: Psychological Placebo (Behavioral)
Drug
Participants only take SSRIs and/or SNRIs through the trial at a recommended dosage.
干预措施: SSRIs and/or SNRIs (Drug)
结局指标
主要结局
changes of The Hamilton Depression Scale (HAMD-17)
时间窗: At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
Scale total range is 52. Lower score represents a better outcome.
changes of The Hamilton Anxiety Scale (HAMA-14)
时间窗: At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
Scale total range is 56. Lower score represents a better outcome.
次要结局
- changes of The Patient Health Questionnaire (PHQ-9)(At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.)
- changes of The GAD-7(At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.)
- changes of The Mos 36-item Short Form Health Survey (SF-36)(At baseline, 4-week, 8-week, 12-week, 20-week, 32-week and 56-week.)
- changes of Treatment Emergent Symptom Scale (TESS)(At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.)
- changes of Clinical Global Impression (CGI)(At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.)