Efficacy and Sustainability of a Hybrid Psychological Intervention Integrating Resilience Theory and the Satir Model on Depression, Resilience, and Quality of Life in Adolescents: A Multi-center, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Change in Depressive Symptoms as Measured by the 17-item Hamilton Depression Rating Scale (HAMD-17)
研究概览
简要总结
This multi-center, randomized controlled trial was conducted to evaluate the efficacy and long-term effects of a novel hybrid psychological intervention, which combines Resilience Theory with the Satir Model, for adolescents diagnosed with depression. The study compared this intervention to treatment as usual (TAU) to determine its impact on depressive symptoms, psychological resilience, self-esteem, and overall quality of life.
详细描述
Adolescent depression is a significant and growing public health concern. Traditional therapies have limitations, highlighting a need for innovative, engaging interventions. This study was designed to address this gap by developing and testing a hybrid model that integrates the strengths-based approach of Resilience Theory with the systemic, humanistic principles of the Satir Model. The study hypothesized that this combined intervention would be more effective than standard care in not only alleviating depressive symptoms but also in building lasting psychosocial resources. A total of 420 adolescents with depression were randomized to either the 12-week hybrid intervention group or a control group receiving treatment as usual. The intervention program was structured in three modules focusing on self-awareness, skill-building, and future-orientation. Outcomes were assessed at baseline, immediately post-intervention (12 weeks), and at a 6-month follow-up to evaluate the sustainability of the effects.
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
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a major depressive episode according to DSM-5 criteria, confirmed by two independent psychiatrists.
- •First episode, with a duration of 4 weeks to 12 months.
- •Age between 13 and 18 years.
- •HAMD-17 score ≥
- •Capable of normal communication.
- •Provision of informed consent by both the adolescent and legal guardians.
排除标准
- •Lifetime diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders.
- •Depression secondary to a general medical condition or substance use.
- •Acute suicidal risk (score ≥ 4 on MADRS item 10) requiring immediate intensive care.
- •Currently receiving structured psychotherapy.
- •Severe neurological or physical illness that could interfere with participation.
研究组 & 干预措施
Experimental: Resilience-Satir Hybrid Intervention Group
In addition to treatment as usual (TAU), participants received a structured 12-week group nursing intervention program. The program consisted of one 90-minute session per week, co-facilitated by trained psychiatric nurses. The intervention included three modules: Module 1 (Weeks 1-4) focused on safety and identifying emotions using Satir's "Iceberg" metaphor and personal strengths; Module 2 (Weeks 5-8) focused on building skills in problem-solving, cognitive reframing, and congruent communication; Module 3 (Weeks 9-12) focused on integrating skills and future-planning.
干预措施: Resilience-Satir Hybrid Intervention (Behavioral)
Active Comparator: Treatment as Usual (TAU) Group
Participants received standard care, which included regular psychiatric assessments, pharmacotherapy as deemed appropriate by the treating psychiatrist (primarily SSRIs), and routine nursing care. Routine care consisted of general health education, basic supportive communication, and monitoring of symptoms and side effects. No structured psychotherapy was provided.
干预措施: Treatment as Usual (TAU) (Other)
结局指标
主要结局
Change in Depressive Symptoms as Measured by the 17-item Hamilton Depression Rating Scale (HAMD-17)
时间窗: Baseline, 12 weeks, 6-month follow-up
A clinician-rated scale assessing the severity of depression. Total scores range from 0 to 52. A lower score indicates a better outcome.
Change in Depressive Symptoms as Measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)
时间窗: Baseline, 12 weeks, 6-month follow-up
A clinician-rated scale sensitive to changes in core depressive symptoms. Total scores range from 0 to 60. A lower score indicates a better outcome.
Change in Depressive Symptoms as Measured by the Beck Depression Inventory-II (BDI-II)
时间窗: Baseline, 12 weeks, 6-month follow-up
A 21-item self-report questionnaire assessing the severity of depression. A lower score indicates a better outcome.
次要结局
- Change in Psychological Resilience as Measured by the Resilience Scale for Chinese Adolescents (RSCA)(Baseline, 12 weeks, 6-month follow-up)
- Change in Self-Esteem as Measured by the Feelings of Inferiority Scale (FIS)(Baseline, 12 weeks, 6-month follow-up)
- Change in Coping Styles as Measured by the Simplified Coping Style Questionnaire (SCSQ)(Baseline, 12 weeks, 6-month follow-up)
- Change in Medication Adherence as Measured by the Medication Adherence Rating Scale (MARS)(Baseline, 12 weeks, 6-month follow-up)
- Change in Family Function as Measured by the Family APGAR Index(Baseline, 12 weeks, 6-month follow-up)
- Change in Social Support as Measured by the Perceived Social Support Scale (PSSS)(Baseline, 12 weeks, 6-month follow-up)
- Change in Quality of Life as Measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF)(Baseline, 12 weeks, 6-month follow-up)
研究者
Kenan Ren
Principal investigator
The First Hospital of Hebei Medical University