Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-27 @ 4:43 AM
Study NCT ID:
NCT04768959
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2021-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cultivating Well-being in Severe Psychiatric Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-21', 'studyFirstSubmitDate': '2021-02-21', 'studyFirstSubmitQcDate': '2021-02-21', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Well-being', 'timeFrame': 'Change from Well-being at 12 weeks and 6 months', 'description': 'Psychological Well-Being Scales (Ryff, 1995)'}, {'measure': 'Well-being', 'timeFrame': 'Change from Well-being at 12 weeks and 6 months', 'description': 'Satisfaction with life Scale ( Diener et al. 1985)'}], 'secondaryOutcomes': [{'measure': 'Self-esteem', 'timeFrame': 'Change from self-esteem at 12 weeks and 6 months', 'description': 'Rosenberg self-esteem scale (Rosenberg, 1965)'}, {'measure': 'Attachment', 'timeFrame': 'Change from Attachment at 12 weeks and 6 months', 'description': 'Relationship Questionnaire (Bartholomew and Horowitz, 1991)'}, {'measure': 'Psychological Symptoms', 'timeFrame': 'Change from Psychological Symptoms at 12 weeks and 6 months', 'description': 'Symptom Checklist 90-Revised (SCL-90-R; Derogatis, 2002)'}, {'measure': 'Experiential Avoidance', 'timeFrame': 'Change from Experiential Avoidance at 12 weeks and 6 months', 'description': 'The Acceptance and Action Questionnaire (AAQ; Hayes et al.,2004)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'severe psychiatric conditions', 'wellbeing', 'RCT', 'positive psychology', 'third-generation psychotherapy'], 'conditions': ['Wellbeing']}, 'descriptionModule': {'briefSummary': 'The multicomponet psychological intervention is called Feliz-Mente, with third generation therapy components that aims to improve wellbeing and self-enhancement. Without intervening directly on the symptoms, it is expected to increase positive experiences, the use of personal strengths and positive relationships, and aims to build a more meaningful self-narrative in persons with severe psychiatric conditions. Feliz-Mente is a group intervention of 12 sessions in which participants are expected to perform exercises during and between sessions to improve treatment adherence and daily practice. The design for the present study is a randomized controlled trial, which compares the post-intervention measures of the experimental group (group receiving the intervention) with the post-intervention measures of the control group (treatment as usual + waiting list).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) were aged 18-65 years\n* 2\\) had a minimum of motivation and commitment to participate in group therapy\n\nExclusion Criteria:\n\n* 1\\) limited cognitive resources or serious formal thinking disorder and/or\n* 2\\) a concurrent diagnosis of substance dependence or a severe personality disorder that could interfere with benefiting from a psychotherapy group.'}, 'identificationModule': {'nctId': 'NCT04768959', 'acronym': 'FelizMente2', 'briefTitle': 'Cultivating Well-being in Severe Psychiatric Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Cultivating Well-being Beyond Symptomatology in Severe Psychiatric Conditions: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UniversityComplutenseMadrid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Intervention: TAU + waiting list', 'description': 'This control group is a waiting list group. Participants received treatment as usual (TAU). Once the RCT is finished, participants have the chance to participate in the intervention group.'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: TAU + Feliz-Mente Intervention', 'description': 'Feliz-Mente (third generation psychotherapy):The intervention is delivered in a group format with a total of 12 sessions and a maximum of 10 patients per group. The protocol consists of specific exercises: 1: welcome and identification of emotions, 2: identification and amplification of positive emotions, 3: regulation of negative emotions, 4: gratitude, 5: forgiveness, 6: self-compassion, 7: personal strengths, 8: loving-kindness and positive interpersonal relationships, 9: values, 10: purpose of life, 11: resilience, 12: keeping the change and farewell party.', 'interventionNames': ['Behavioral: FelizMente']}], 'interventions': [{'name': 'FelizMente', 'type': 'BEHAVIORAL', 'otherNames': ['Positive psychotherapy'], 'description': "The intervention aims to improve well-being, without denying the existence of symptoms or problems, focusing on generating positive emotions and actions congruent with the person's values through 11 weekly 90-minute group sessions. The multi-component intervention manual was composed of evidence-based exercises of Positive Psychoterapy Interventions, Acceptance and Commitment Therapy and Mindfulness and was theory driven according the broaden-and-build-theory (Fredrickson, 2001) and the self-serving model of paranoia (Murphy et al., 2018). It was also informed by previous pilot studies carried out on people with paranoid tendencies (see Valiente et al., 2020) and with Severe Psyquiatric Condition samples.", 'armGroupLabels': ['Experimental: TAU + Feliz-Mente Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28223', 'city': 'Pozuelo de Alarcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Carmen Valiente', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Carmen Valiente Ots', 'investigatorFullName': 'Carmen Valiente Ots', 'investigatorAffiliation': 'Universidad Complutense de Madrid'}}}}