Group Cognitive Evolutionary Therapy for Depression - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Depressive symptomatology
研究概览
简要总结
The goal of this clinical trial is to measure the effects of Group Cognitive Evolutionary Therapy on mental health, especially on depressive symptoms and anxiety.
Participants will be allocated in one of two conditions: (1) Group Cognitive Evolutionary Therapy (intervention) or (2) Waitlist. The intervention will consist of two 8-hour sessions of Group Cognitive Therapy, in two consecutive days.
The Group Cognitive Evolutionary Therapy group will be compared to the waitlist group to test the efficacy of the intervention.
详细描述
The aim of the study is to assess the efficacy of Group Cognitive Evolutionary Therapy on depressive symptoms and other indicators of mental health for people with mild to severe depressive symptoms. This clinical trial will provide essential insights into the potential benefits of this form of therapy. The results will contribute to the development of a short, economical and effective method of enhancing mental health for patients with mild to severe depressive symptoms.
After recruitment, participants will be randomly assigned to one of two conditions: (1) Group Cognitive Evolutionary Therapy (intervention) or (2) Waitlist.
The intervention group will participate in two 8-hour sessions of Cognitive Evolutionary Therapy over two consecutive days, in groups of no less than 5 and no larger than 8 people. These groups will be led by licensed psychologists with extensive knowledge of evolutionary psychology and cognitive evolutionary therapies.
Both groups will be evaluated at (1) pre-intervention (baseline), (2) one week after the intervention, and (3) three months after the intervention.
G*Power analysis yields a total of N = 44 (f = 0.25, power = 0.95) for the two conditions.
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 (Investigator, 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
- 是
入选标准
- •mild to severe depressive symptoms
- •age 18 to 65
排除标准
- •severe personality traits (antagonism, impulsivity, disinhibition, psychoticism)
- •formally diagnosed with a severe mental disorder
- •currently participating in any ongoing therapeutic intervention for mental health.
研究组 & 干预措施
Waitlist
Waitlist. No intervention for this arm.
Group Cognitive Evolutionary Therapy
In-person therapy groups
干预措施: Group Cognitive Evolutionary Therapy (Behavioral)
结局指标
主要结局
Depressive symptomatology
时间窗: up to 6 months
Depressive symptomatology will be assessed with the 21-item Depression Anxiety and Stress Scale (DASS 21). Participants assign ratings on a scale of 0 to 3 based on how often they experienced specific items in the preceding 1-week timeframe (0- not at all; 3 - nearly every day). The depression subscale is a 7-question self-reported instrument that assesses dysphoria, hopelessness, devaluation of life, self-depreciation, lack of interest, anhedonia and inertia. Clinical cutoffs are provided.
Anxiety symptomatology
时间窗: up to 6 months
Anxiety symptomatology will be assessed with the Depression Anxiety and Stress Scale (DASS 21), a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. The anxiety scale is a 7-question self-reported instrument designed to assess autonomic arousal, skeletal muscle effects, situation, anxiety, and subjective experience of anxious affect. Participants assign ratings on a scale of 0 to 3 based on how often they experienced specific items in the preceding 1-week timeframe (0 - not at all; 3 - most of the time). The total score for the seven items ranges from 0 to 21 and is a dimensional value.
次要结局
- Sleep quality(up to 6 months)
- Social provisions(up to 6 months)
- Satisfaction with life(up to 6 months)
- Stress(up to 6 months)
- Self-perceived mate value(up to 6 months)
研究者
Cezar Giosan
Associate Professor of Psychology
University of Bucharest