Group Program vs Single-Session Depathologizing Intervention for Subthreshold Anxiety-Depression … (NCT07363915) | Clinical Trial Compass
CompletedNot Applicable
Group Program vs Single-Session Depathologizing Intervention for Subthreshold Anxiety-Depression in Primary Care (Spain)
Spain136 participantsStarted 2021-02-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Anxiety symptoms (STAI-State and STAI-Trait total scores)