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

NCT07363915 | Completed

• 3 other identifiers: CEIM32-2019-OE18-2019UAH thesis 114730332/2019 (OE 18/2019)
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Depressive Symptoms; Anxiety Symptoms; Subthreshold Depression

Keywords

Primary Care; Subthreshold Anxiety; Subthreshold Depression; Psychological Intervention; Cognitive Behavioral Therapy; Single-Session Intervention; Randomized Controlled Trial; Depathologizing

Outcome Measures

Primary Outcomes (2)

• Anxiety symptoms (STAI-State and STAI-Trait total scores)

  State-Trait Anxiety Inventory (STAI), State and Trait subscales, total scores. Higher scores indicate greater anxiety symptom severity.

  Baseline and 12 months

• Depressive symptoms (BDI total score)

  Beck Depression Inventory (BDI), total score. Higher scores indicate greater depressive symptom severity.

  Baseline and 12 months

Secondary Outcomes (4)

• 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

Study Arms (2)

PADAP group program (10 sessions)

ACTIVE COMPARATOR

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).

Behavioral: PADAP transdiagnostic CBT-based group program

Single-session depathologizing intervention (SSDI)

ACTIVE COMPARATOR

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.

Behavioral: Active Single-Session Depathologizing Intervention (SSDI)

Interventions

PADAP transdiagnostic CBT-based group program BEHAVIORAL

Manualized, multimodal, transdiagnostic cognitive-behavioral group intervention delivered in 10 weekly sessions (90 minutes each) by trained clinical psychology residents. Content includes psychoeducation about emotions; anxiety management (physiological arousal management, cognitive restructuring, problem solving); sadness management (behavioral activation, increasing positive reinforcement); and anger management (anger regulation and assertiveness training).

PADAP group program (10 sessions)

Active Single-Session Depathologizing Intervention (SSDI) BEHAVIORAL

Structured individual single-session intervention (50-60 minutes) delivered by trained clinical psychologists/clinical psychology residents. The session focuses on empathic listening and shared formulation; contextualization and normalization of distress; de-pathologizing explanations by challenging symptoms-as-disease narratives; narrative reframing; and activation of personal and social resources outside the healthcare system.

Single-session depathologizing intervention (SSDI)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Referred from primary care by a general practitioner.
• \. Mild to moderate anxious-depressive symptoms based on the GP's clinical judgement during routine consultations, with or without psychotropic medication.

You may not qualify if:

• \. Receiving active mental health treatment (public or private).
• \. Current substance dependence (except nicotine).
• \. Organic, neurological, or cognitive disorder related to the symptoms.
• \. Language barriers that precluded participation or completion of assessments.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Hospital Universitario Príncipe de Asturias (recruitment from 4 primary care centres), Spain

Alcalá de Henares, Madrid, 28806, Spain

Location

Related Links

• Doctoral thesis (protocol and full methods)

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Diego Sanchez Ruiz

  University of Alcala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm, parallel-group randomized controlled trial comparing PADAP group intervention versus a single-session depathologizing intervention (SSDI).

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 23, 2026
• Study Start: February 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)