AnxietyNCT07363915
Group Program vs Single-Session Depathologizing Intervention for Subthreshold Anxiety-Depression in Primary Care (Spain)
A study testing PADAP transdiagnostic CBT-based group program and Active Single-Session Depathologizing Intervention (SSDI) in people with Anxiety and Depressive Symptoms, run by University of Alcala at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Depressive Symptoms, Anxiety Symptoms
- What is being tested?
- PADAP transdiagnostic CBT-based group program and Active Single-Session Depathologizing Intervention (SSDI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Príncipe de Asturias (recruitment from 4 primary care centres), Spain
Alcalá de Henares, Madrid, 28806
About this study
Official 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
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.
Read the 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.
- Being tested
- PADAP transdiagnostic CBT-based group program, Active Single-Session Depathologizing Intervention (SSDI)
- Keywords
- Primary Care, Subthreshold Anxiety, Subthreshold Depression, Psychological Intervention, Cognitive Behavioral Therapy, Single-Session Intervention, Randomized Controlled Trial, Depathologizing
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PADAP transdiagnostic CBT-based group programBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Active Single-Session Depathologizing Intervention (SSDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
Depressive symptoms (BDI total score)
Beck Depression Inventory (BDI), total score. Higher scores indicate greater depressive symptom severity.
Measured: Baseline and 12 months
Secondary outcomes (4)
GP mental health-related consultations (12 months pre vs 12 months post)
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).
Measured: 12 months before intervention and 12 months after intervention
Psychotropic medication use (yes/no)
Use of psychotropic medication (antidepressants, anxiolytics, both, or other mood-affecting medication). For analysis, coded as yes/no.
Measured: Baseline and 12 months
New contact with mental health services (yes/no)
Recorded as yes if the participant requested or received psychological or psychiatric care (public or private) during follow-up.
Measured: 12 months
Perceived need for referral or additional care (yes/no)
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.
Measured: 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Feb 2021
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group randomized controlled trial comparing PADAP group intervention versus a single-session depathologizing intervention (SSDI).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Sanchez Ruiz, University of Alcala
- Investigators
- Diego Sanchez Ruiz, Principal investigator, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363915
- Sponsor's protocol ID
- CEIM32-2019-OE18-2019
- Other IDs
- UAH thesis 1147303, 32/2019 (OE 18/2019)
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07363915
- Acronym / sponsor ID
- CEIM32-2019-OE18-2019
- Keywords
- Primary Care, Subthreshold Anxiety, Subthreshold Depression, Psychological Intervention, Cognitive Behavioral Therapy, Single-Session Intervention, Randomized Controlled Trial, Depathologizing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized controlled trial comparing PADAP group intervention versus a single-session depathologizing intervention (SSDI).
| Arm | Type | Receives |
|---|---|---|
| PADAP group program (10 sessions) | Active comparator | Behavioral: PADAP transdiagnostic CBT-based group programManualized, 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). |
| Single-session depathologizing intervention (SSDI) | Active comparator | Behavioral: Active 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PADAP transdiagnostic CBT-based group programManualized, 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). | Behavioural | PADAP group program (10 sessions) |
| 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. | Behavioural | Single-session depathologizing intervention (SSDI) |
Primary outcome
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.
Depressive symptoms (BDI total score)
Time frame: Baseline and 12 months
Beck Depression Inventory (BDI), total score. Higher scores indicate greater depressive symptom severity.
4 secondary outcomes
GP mental health-related consultations (12 months pre vs 12 months post)
Time frame: 12 months before intervention and 12 months after intervention
Psychotropic medication use (yes/no)
Time frame: Baseline and 12 months
New contact with mental health services (yes/no)
Time frame: 12 months
Perceived need for referral or additional care (yes/no)
Time frame: 12 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Doctoral thesis (protocol and full methods)Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Sanchez Ruiz principal investigator
University of Alcala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PADAP transdiagnostic CBT-based group program and Active Single-Session Depathologizing Intervention (SSDI) in people with Anxiety and Depressive Symptoms, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety symptoms (STAI-State and STAI-Trait total scores) (time frame: Baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.