A Randomized Controlled Trial Comparing a Manualized Group Program (PADAP) Versus an Active Single-Session Depathologizing Intervention (SSDI) for Subthreshold Anxious-Depressive Symptoms in Primary Care in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Anxiety symptoms (STAI-State and STAI-Trait total scores)
研究概览
简要总结
This study evaluated two psychological interventions for adults with mild to moderate subthreshold anxious-depressive symptoms in primary care in Spain. Participants referred by general practitioners were randomly assigned to either (1) PADAP, a manualized transdiagnostic group program delivered in 10 weekly 90-minute sessions, or (2) a structured active single-session depathologizing intervention (SSDI), delivered individually in one 50-60-minute session.
The primary aim was to compare changes in depressive and anxiety symptoms from baseline to 12 months. Secondary aims included comparing primary care mental health-related consultations, psychotropic medication use, new contacts with mental health services, and perceived need for further mental health care during follow-up.
详细描述
This was a prospective, parallel-group randomized controlled trial conducted in four primary care health centres in a large urban area in Spain. Adults aged 18-65 years referred by general practitioners for mild to moderate anxious-depressive symptoms were screened for eligibility. Exclusion criteria included meeting DSM-IV Axis I or II criteria based on the Structured Clinical Interview (SCID-I), current active treatment in mental health services, current substance dependence (except nicotine), organic/neurological/cognitive disorders related to symptoms, or language barriers. All participants provided written informed consent, and the study received ethics approval (reference 32/2019 [OE 18/2019]).
Eligible participants were allocated using a centralized, computerized randomization system to one of two intervention arms. Outcome assessment was performed by a blinded assessor. Participants assigned to SSDI received an individual, structured 50-60-minute session focused on empathic listening, contextualization and normalization of distress, narrative reframing, and activation of personal and social resources outside the healthcare system. Participants assigned to PADAP received a manualized, multimodal, transdiagnostic cognitive-behavioral group intervention delivered in 10 weekly 90-minute sessions covering psychoeducation about emotions and skills to manage anxiety, sadness, and anger.
Depressive symptoms were measured with the Beck Depression Inventory (BDI), and anxiety symptoms with the State-Trait Anxiety Inventory (STAI). Assessments were conducted at baseline and at 12 months. Data on primary care consultations for mental health reasons were extracted from electronic health records, along with information on psychotropic medication use and new contacts with mental health services during follow-up.
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)
盲法说明
Outcome assessment at 12 months was performed by assessors blinded to group assignment. Participants and intervention providers were not blinded. Baseline assessment for the SSDI arm was conducted by the clinician delivering the intervention.
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
- •Adults aged 18-65 years.
- •2. Referred from primary care by a general practitioner.
- •3. Mild to moderate anxious-depressive symptoms based on the GP's clinical judgement during routine consultations, with or without psychotropic medication.
排除标准
- •Meeting DSM-IV Axis I diagnostic criteria based on the Structured Clinical Interview (SCID-I), assessed by two clinical resident psychologists.
- •2. Receiving active mental health treatment (public or private).
- •3. Current substance dependence (except nicotine).
- •4. Organic, neurological, or cognitive disorder related to the symptoms.
- •5. Language barriers that precluded participation or completion of assessments.
研究组 & 干预措施
PADAP group program (10 sessions)
Manualized, multimodal, transdiagnostic cognitive-behavioral group intervention delivered in 10 weekly sessions (90 minutes each) by trained clinical psychology residents. Modules cover emotions (psychoeducation), anxiety (physiological arousal management, cognitive restructuring, problem solving), sadness (behavioral activation), and anger (anger regulation and assertiveness training).
干预措施: PADAP transdiagnostic CBT-based group program (Behavioral)
Single-session depathologizing intervention (SSDI)
Structured individual single-session intervention (50-60 minutes) delivered by trained clinical psychology residents. The session focuses on empathic listening, shared formulation, contextualization and normalization of distress, narrative reframing (challenging symptoms-as-disease explanations), and activation of personal and social resources outside the healthcare system.
干预措施: Active Single-Session Depathologizing Intervention (SSDI) (Behavioral)
结局指标
主要结局
Anxiety symptoms (STAI-State and STAI-Trait total scores)
时间窗: Baseline and 12 months
State-Trait Anxiety Inventory (STAI), State and Trait subscales, total scores. Higher scores indicate greater anxiety symptom severity.
Depressive symptoms (BDI total score)
时间窗: Baseline and 12 months
Beck Depression Inventory (BDI), total score. Higher scores indicate greater depressive symptom severity.
次要结局
- GP mental health-related consultations (12 months pre vs 12 months post)(12 months before intervention and 12 months after intervention)
- Psychotropic medication use (yes/no)(Baseline and 12 months)
- New contact with mental health services (yes/no)(12 months)
- Perceived need for referral or additional care (yes/no)(12 months after intervention)
研究者
Diego Sanchez Ruiz
Principal Investigator
University of Alcala