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

NCT07363915 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2026-01-23

No results posted yet for this study

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

Interventions

BEHAVIORAL

PADAP transdiagnostic CBT-based group program

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).

BEHAVIORAL

Active Single-Session Depathologizing Intervention (SSDI)

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.

Sponsors & Collaborators

  • University of Alcala

    lead OTHER

Principal Investigators

  • Diego Sanchez Ruiz · University of Alcala

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-09-01
Completion
2023-09-01

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07363915 on ClinicalTrials.gov