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Completed

NCT Number: NCT07363915

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

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Key information

Conditions

Anxiety Anxiety Disorders Anxiety Symptoms Behavior Behavioral Symptoms Depression Depressive Symptoms Mental Disorders Subthreshold Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alcalá de Henares, Madrid, 28806, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1. Adults aged 18-65 years.

  • 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.

Exclusion criteria

1. Meeting DSM-IV Axis I diagnostic criteria based on the Structured Clinical Interview (SCID-I), assessed by two clinical resident psychologists.

  • 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.

Treatment and study plan

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).

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.

Primary outcomes

  1. 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.

  2. Depressive symptoms (BDI total score)

    Time frame: Baseline and 12 months

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

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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