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

January 14, 2026 updated by: Diego Sanchez Ruiz, University of Alcala

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28806
        • Hospital Universitario Príncipe de Asturias (recruitment from 4 primary care centres), Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
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).
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety symptoms (STAI-State and STAI-Trait total scores)
Time Frame: Baseline and 12 months
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)
Time Frame: Baseline and 12 months
Beck Depression Inventory (BDI), total score. Higher scores indicate greater depressive symptom severity.
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GP mental health-related consultations (12 months pre vs 12 months post)
Time Frame: 12 months before intervention and 12 months after intervention
Number of general practitioner (GP) consultations for mental health reasons extracted from electronic health records (AP Madrid/Horus/HCIS), measured for two periods: (1) the 12 months prior to baseline assessment, and (2) the 12 months following the intervention (post-baseline).
12 months before intervention and 12 months after intervention
Psychotropic medication use (yes/no)
Time Frame: Baseline and 12 months
Use of psychotropic medication (antidepressants, anxiolytics, both, or other mood-affecting medication). For analysis, coded as yes/no.
Baseline and 12 months
New contact with mental health services (yes/no)
Time Frame: 12 months
Recorded as yes if the participant requested or received psychological or psychiatric care (public or private) during follow-up.
12 months
Perceived need for referral or additional care (yes/no)
Time Frame: 12 months after intervention
Based on the question: "Do you think you need to be referred to mental health services or receive any other additional intervention from us?". Coded as yes for affirmative responses and for participants who requested referral and were on a waiting list or under follow-up.
12 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Investigators

  • Principal Investigator: Diego Sanchez Ruiz, University of Alcala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIM32-2019-OE18-2019
  • UAH thesis 1147303 (Other Identifier: Universidad de Alcala de Henares)
  • 32/2019 (OE 18/2019) (Other Identifier: CEIm Hospital Universitario Príncipe de Asturias)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets generated and/or analysed during the current study are not publicly available due to the risk of compromising participant privacy and because they include information derived from electronic health records, but are available from the corresponding author on reasonable request and subject to approval by the relevant data controller/health service.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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