Group Program vs Single-Session Depathologizing Intervention for Subthreshold Anxiety-Depression in Primary Care (Spain)

University of Alcala

Status: Completed

Conditions: Depressive Symptoms; Anxiety Symptoms; Subthreshold Depression; Anxiety

Treatments: Behavioral: Active Single-Session Depathologizing Intervention (SSDI); Behavioral: PADAP transdiagnostic CBT-based group program

Study type: Interventional

Funder types: Other

Identifiers

NCT07363915

UAH thesis 1147303 (Other Identifier)

32/2019 (OE 18/2019) (Other Identifier)

CEIM32-2019-OE18-2019

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 136 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: 1. 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.

Exclusion Criteria: 1. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

136 participants in 2 patient groups

PADAP group program (10 sessions)

Active Comparator group

Description:

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).

Treatment:

Behavioral: PADAP transdiagnostic CBT-based group program

Single-session depathologizing intervention (SSDI)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Active Single-Session Depathologizing Intervention (SSDI)