Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-05 @ 5:27 PM
Study NCT ID:
NCT06894368
Status:
COMPLETED
Last Update Posted:
2025-09-16
First Post:
2025-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Group Version of the UP-A in a Spanish Public Mental Health Setting.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-03-24', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Anxiety and Depressive Symptoms as Assessed by RCADS-30', 'timeFrame': 'Up to 12 months', 'description': 'The Revised Child Anxiety and Depression Scale-30 (RCADS-30; Sandín et al., 2010) at pre, post-intervention and 3, 6 and 12 months follow-up.\n\nRange from 0 to 90. Symptoms of anxiety (panic disorder, social phobia, separation anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder) and depressive disorders symptoms.\n\nHigher scores mean a worse outcome.\n\nParents completed the "parent version" of the RCADS.'}, {'measure': "Changes in Anxiety and Depressive Symptoms's Interference as Assessed by EIDAN", 'timeFrame': 'Up to 12 months', 'description': 'Depression and Anxiety Interference Scale for Children and Adolescents EIDAN (Espinosa et al., 2022) . It is a 10-item self-reported instrument that evaluates the interference of emotional symptoms in the adolescent\'s daily functioning in the previous weeks, in several contexts (school, family and with peers). The higher the score, the higher the level of interference. Assessed at pre, post-intervention and 3, 6 and 12 months follow-up.\n\nRange from 10 to 40. Parents completed the "parent version" of the EIDAN.'}, {'measure': 'Top Problems Measure', 'timeFrame': 'Up to 12 months', 'description': 'The adolescent version of the Top Problem Assessment (TPA) (Ehrenreich, 2018; adapted from Weisz et al., 2011) was used to enhance treatment outcomes and strengthen the therapeutic alliance. Adolescents were asked to write down the issues that concerned them the most and assess the severity of each problem by rating its impact on daily functioning on a scale from 0 ("not a problem at all") to 10 ("very, very much a problem"). Each adolescent selected between one and three problems and evaluated their severity at five time points: at the beginning of the program (session 3), mid-treatment (session 8), the final session (session 16), and during follow-ups at 3, 6 and 12 months.'}, {'measure': 'Changes in Emotion Regulation Strategies as Assessed by CERE', 'timeFrame': 'Up to 12 months', 'description': 'Emotion Regulation Strategies Questionnaire CERE-II (Sandín et al., 2008). Adapted to Spanish by Sandín et al. (2008).\n\nEvaluates 7 subscales of the "emotion regulation" construct at pre, post-intervention and 3, 6 and 12 months follow-up.\n\nHigher scores in maladaptive regulation strategies (supression; rumination; distraction) and lower scores in adaptive strategies (attention/awareness/understanding; acceptance/tolerance; cognitive reappraisal; self-instructions) mean a worst outcome'}], 'secondaryOutcomes': [{'measure': 'Changes in Depressive Symptoms as Assessed by CDN', 'timeFrame': 'Up to 12 months', 'description': 'The Depression Questionnaire for Children and Adolescents \\[Cuestionario de Depresión para Niños y Adolescentes\\] (CDN; Sandín et al., 2016) at pre, post-intervention and 3, 6 and 12 months follow-up.\n\nRange from 0 to 48. Depressive symptoms. Higher scores mean a worse outcome.'}, {'measure': 'Changes in Positive and Negative Affect as Assessed by PANASN', 'timeFrame': 'Up to 12 months', 'description': 'The Children Positive and Negative Affect Schedule \\[Escalas PANAS para niños y adolescentes\\] (PANASN; Sandín, 2003) at pre, post-intervention and 3, 6 and 12 months follow-up. Positive and negative affect. Range 10-30. Higher scores of negative affect and lower scores os positive affect mean a worse outcome.'}, {'measure': 'Changes in Anxiety Sensitivity as Assessed by CASI', 'timeFrame': 'Up to 12 months', 'description': 'Childhood Anxiety Sensitivity Index CASI (Silverman et al., 1991) ; Spanish adaptation by (Sandín et al., 2002). Anxiety sensitivity at pre, post-intervention and 3, 6 and 12 months follow-up.\n\nRange 18 to 54. Higher scores mean a worse outcome.'}, {'measure': 'Changes in Emotional Avoidance as Assessed by EASI', 'timeFrame': 'Up to 12 months', 'description': 'Emotional Avoidance Strategy Inventory for Adolescents EASI-A ( Kennedy \\& Ehrenreich-May, 2017) ; Spanish adaptation by (García-Escalera et al., 2016). Emotional avoidance strategies at pre, post-intervention and 3, 6 and 12 months follow-up.\n\nRange 0 to 68. Higher scores mean a worse outcome.'}, {'measure': 'Changes in Satisfaction with Life as Assessed by SWLS', 'timeFrame': 'Up to 12 months', 'description': 'Satisfaction with Life Scale SWLS (Diener et al., 2010; adapted to Spanish by Sandín et al., 2015).\n\nEvaluates satisfaction with life at pre, post-intervention and 3, 6 and 12 months follow-up. Range 5 to 20. Lower scores mean a worse outcome.'}, {'measure': 'Changes in Attachment Styles as Assessed by ARSQ', 'timeFrame': 'Up to 12 months', 'description': 'Adolescent Relationships Scales Questionnaire ARSQ (Scharfe, 1999) ; adapted to Spanish by (Magaz et al., 2011). The ARSQ is an instrument composed of 17 self-reported items, which allows obtaining scores for the three types of attachment identified in the theory of Bartholomew (1990) and Bartholomew and Horowitz (1991): secure attachment, fearful/preoccupied attachment, and avoidant attachment. Evaluates attachment styles at pre, post-intervention and 3, 6 and 12 months follow-up.\n\nHigher scores in insecure attachment styles (fearful/preoccupied attachment, and avoidant attachment) and lower scores in secure attachment style mean a worst outcome.'}, {'measure': 'Changes in Somatic Symptoms as Assessed by PHQ-15', 'timeFrame': 'Up to 12 months', 'description': 'Somatic Symptoms Scale extracted from the PHQ-15, Patient Health Questionnaire (adapted from the patient health questionnaire - physical symptoms - PHQ-15; (Kroenke et al., 2002) ; Extracted and translated from the APA website - DSM-5 Level 2 Cross -Cutting Symptom Measures). It is composed of 13 items that evaluate somatic symptoms in adolescents between 11 and 17 years old at pre, post-intervention and 3, 6 and 12 months follow-up. Range 0 to 26. Higher scores mean a worse outcome.'}, {'measure': 'Changes in Severity of Clinical Diagnosis as Assessed by CSR', 'timeFrame': '16 weeks', 'description': "The Clinician Severity Rating CSR (ADIS-IV Interview; Silverman et al., 2008). This scale indicates, for each main and secondary diagnosis, the clinician's estimate of severity according to the following scale from 0 to 8: 0 = no seriousness, 1 - 2 = little disturbance/no disabling, 3 - 5 = clear disturbance/disabling (at least a 4 is required for diagnosis) 6 - 7 = high/disabling disturbance; 8 = very serious/disabling disturbance. Assessed at pre and post-treatment."}, {'measure': 'Changes in Level of Functioning as Assessed by CGAS', 'timeFrame': 'Up to 12 months', 'description': "The Children's Global Assessment Scale CGAS (Schaffer et al., 1983; version translated into Spanish by the Xunta de Galicia Agreement and the University of A Coruña Foundation, 2012). It is a clinician-estimated measure of the adolescent's overall level of functioning in the last month. Scores range from 100-91 (optimal functioning in all areas) to 10-1 (constant need for supervision).\n\nEvaluates General Functioning at pre, post-intervention and 3, 6 and 12 months follow-up."}, {'measure': 'Changes in Clinician Estimated Severity of Anxiety and Depressive Symptoms as Assessed by CGI-S', 'timeFrame': 'Up to 12 months', 'description': 'The Clinical Global Impression (Severity) Scale CGI-S (Guy, 1976) . Using this scale, the clinician estimated the severity of the adolescent\'s anxiety and depression symptoms. Scores will range from 1 ("Normal, not at all ill"), to 7 ("Extremely ill").\n\nEvaluated at pre, post-intervention and 3, 6 and 12 months follow-up.'}, {'measure': 'Changes in Clinician Estimated Improvement of Anxiety and Depressive Symptoms as Assessed by CGI-I', 'timeFrame': 'Up to 12 months', 'description': 'The Clinical Global Impressions (Improvement) Scale CGI-I (Guy, 1976) . This scale was completed by the clinicians during post-treatment and follow-ups. The adolescent\'s improvement was scored on a scale from 1 to 7, with 1 being "very much improved" and 7 being "very much worse".\n\nAssessed at post-intervention and 3, 6 and 12 months follow-up.'}, {'measure': 'Satisfaction with the program and therapeutic alliance', 'timeFrame': '16 weeks', 'description': 'In the post-treatment evaluation, adolescents and involved parents completed a 12-item questionnaire that evaluates satisfaction with the program and the quality of the relationship with the therapist (Sandín et al., 2020).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Unified Protocol', 'Emotional Disorders', 'Adolescents', 'Public Mental Health', 'UP-A', 'Spain'], 'conditions': ['Anxiety Disorders', 'Depressive Disorder', 'Emotional Disorder']}, 'descriptionModule': {'briefSummary': 'The study aims to adapt the Spanish version of the UP-A to a group format in a public mental health setting for adolescents with moderate emotional symptoms and evaluate its clinical utility and feasibility. This includes assessing anxiety, depression, transdiagnostic variables, engagement, and satisfaction from adolescents, parents, and clinicians, with follow-ups at 3, 6 and 12 months. The goal is to improve adolescent mental health and explore whether this approach could help alleviate the pressure on public healthcare services.', 'detailedDescription': 'Anxiety and depression are among the most prevalent mental health disorders in adolescents, with growing concerns about their increasing incidence. Studies indicate that emotional disorders often co-occur due to shared transdiagnostic factors, such as poor emotion regulation, high negative affect, and cognitive avoidance. Given these shared mechanisms, transdiagnostic treatments like the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) have been developed to improve adaptive emotion regulation and reduce avoidance behaviors. While the UP-A has been primarily evaluated as an individual therapy, its adaptation to a group format could enhance accessibility and efficiency, particularly in public mental health settings.\n\nThis study aims to adapt the Spanish version of the UP-A to a group format for adolescents with moderate emotional symptoms in a public mental health setting and assess its clinical utility and feasibility. The program is administered at a public mental health center in Madrid, with 31 adolescents (ages 11-17) diagnosed with emotional disorders. The intervention consists of 16 weekly sessions for adolescents, alongside three parental sessions. The program incorporates modifications such as individual sessions for defining personal treatment goals, structured peer support, and behavioral reinforcement strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presenting a primary diagnosis of an emotional disorder with mild or moderate severity, including the following disorders based on DSM-5 categories: Depressive Disorders (Major Depressive Disorder and Persistent Depressive Disorder), Anxiety Disorders (Specific Phobia, Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder), Obsessive-Compulsive and Related Disorders (including Body Dysmorphic Disorder, Hoarding Disorder, Trichotillomania and Excoriation (Skin-Picking) Disorder), Trauma and Stressor-Related Disorders (Reactive Attachment Disorder, Post-Traumatic Stress Disorder, Acute Stress Disorder and Adjustment Disorders), Dissociative Disorders (Dissociative Identity Disorder, Depersonalization/Derealization Disorder) and Somatic Symptom and Related Disorders (Somatic Symptom Disorder and Illness Anxiety Disorder). Specified and unspecified disorders from the above categories were also included.\n* Being 11-18 years of age\n* Being proficient in Spanish\n* The adolescent being able to attend the treatment sessions\n* At least one of the adolescent's parents or legal guardians being able to attend the parents' treatment sessions\n* If the participant was taking psychiatric medication, the dose was required to remain stable for at least 1 month before the start of treatment and throughout it\n\nExclusion Criteria:\n\n* Presenting self-harm or suicidal ideation in a moderate or severe degree\n* Presenting certain of the following clinical conditions (either as a main or comorbid diagnosis): Neurodevelopmental Disorders (Intellectual Disability or Autism Spectrum Disorder); Disruptive, Impulse-Control and Conduct Disorders; Eating Disorders; Psychotic Spectrum Disorders or psychotic-type symptoms,; Substance Abuse Disorders (excluding cannabis, coffee and/or nicotine); high severity Emotional Disorders; and Bipolar Disorders\n* The characteristics or severity of the symptoms presented by the adolescent requiring an individual intervention or one adapted to the specific clinical condition\n* Be receiving public or private psychological treatment during the UP-A program\n* Suffering from a serious medical illness that made the adolescent's participation in the treatment program unsustainable\n* The participant, or if under 16 years of age, his or her parents, having refused to sign the informed consent"}, 'identificationModule': {'nctId': 'NCT06894368', 'briefTitle': 'Group Version of the UP-A in a Spanish Public Mental Health Setting.', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Nacional de Educación a Distancia'}, 'officialTitle': 'Development and Evaluation of a Group Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) in a Spanish Public Mental Health Setting.', 'orgStudyIdInfo': {'id': '1-PSI-2023/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Intervention Group of an uncontrolled study.', 'interventionNames': ['Behavioral: UP-A']}], 'interventions': [{'name': 'UP-A', 'type': 'BEHAVIORAL', 'description': "The intervention is a group adaptation of the Spanish version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A; Ehrenreich-May et al., 2018, 2020, 2022). It consists of 16 weekly 90-minute sessions held in person at a public Mental Health Center. The intervention also includes three in-person group sessions for parents, each lasting one hour, held at the beginning, middle, and end of the program. These sessions cover content from the therapist's guide, including the Parent Module (Parenting the Emotional Adolescent), and provide a space for questions and emotional support.", 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28221', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Centro de Salud Mental de Majadahonda', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Paloma Chorot, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad Nacional de Educación a Distancia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Nacional de Educación a Distancia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Puerta de Hierro University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Julia García Escalera', 'investigatorAffiliation': 'Universidad Nacional de Educación a Distancia'}}}}