Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT05594160
Status:
COMPLETED
Last Update Posted:
2022-10-26
First Post:
2022-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Agentic Self-view as Common Factor in Psychotherapy - Self-efficacy in the Treatment of Inpatients Over the Course of Time
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011613', 'term': 'Psychotherapy'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1544}, 'targetDuration': '10 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-21', 'studyFirstSubmitDate': '2022-10-21', 'studyFirstSubmitQcDate': '2022-10-21', 'lastUpdatePostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Checklist Short Form (SCL-K11)', 'timeFrame': 'Weekly assessment of each patient over the course of an (usually) 8-week inpatient psychotherapy treatment program. Data will be reported for 6 years of continuous study enrolment.', 'description': 'Symptom measure assessing depressive and anxiety related symptoms with 11 items'}], 'secondaryOutcomes': [{'measure': 'Inpatient and day clinic experiences questionnaire (IDES) - Subscale Positive Self', 'timeFrame': 'Weekly assessment of each patient over the course of an (usually) 8-week inpatient psychotherapy treatment program. Data will be reported for 6 years of continuous study enrolment.', 'description': "Subscale assessing patients' sense of themselves by measuring self-efficacy and self-evaluation"}, {'measure': 'Inpatient and day clinic experiences questionnaire (IDES) - Subscale Group Cohesion', 'timeFrame': 'Weekly assessment of each patient over the course of an (usually) 8-week inpatient psychotherapy treatment program. Data will be reported for 6 years of continuous study enrolment.', 'description': 'Subscale assessing the quality of the relationships between patients in an inpatient psychotherapy program'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inpatient Psychotherapy', 'Self Efficacy', 'Group Cohesion', 'Treatment Outcome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the development of self-efficacy over the course of psychotherapeutic inpatient treatment and to examine the interplay of symptom severity with group cohesion and positive self-view, respectively. Moreover, variables that potentially moderate the relationship between positive self-view and treatment outcome will be investigated.', 'detailedDescription': "In this study, the aim is to investigate the role of patients' self-efficacy in inpatient psychotherapeutic treatment. More specifically, it will be explored whether patients' positive self-view over the course of psychotherapeutic treatment is linked to symptom severity throughout and at the end of inpatient treatment. Moreover, the interplay between positive self-view and other variables that could potentially influence the psychotherapeutic process such as patients' group cohesion will be investigated. Therefore, it will be examined whether changes in positive self-view and in group cohesion precede and explain symptom change. Furthermore, another objective of the study is to examine whether certain patient characteristics influence the relation between positive self-view and treatment outcome. More precisely, it will be investigated whether patient characteristics such as attachment style and tendency to self-criticism act as potential moderator variables. It is expected that positive self-view as well as stronger group cohesion will lead to subsequent symptom improvement. Additionally, it is expected that reciprocal relations between symptom severity with both positive self-view and group cohesion will be found.\n\nFor the above described purposes, data of ca. 1500 adult patients will be used that has been obtained over the course of an (usually) 8-week inpatient psychotherapeutic treatment in the years 2015 to 2021 in Heidelberg University Hospital. Patients filled in pre- as well as post-treatment questionnaires of psychotherapy outcome measures and took part in weekly questionnaire assessments of clinically relevant process variables over the course of treatment. Therefore, data analysis will be performed using the described longitudinal panel data.\n\nTo examine the influence of positive self-view on symptom severity as well as the interplay of self-view and group cohesion random-intercept cross-lagged dynamic panel models (RI-CLPM) will be used. To investigate potential moderator variables of the relation between self-efficacy and treatment outcome moderated multilevel regression models will be calculated.\n\nThus, the general aim of this study is to shed more light on process variables and patient characteristics that might play a role in the psychotherapeutic inpatient treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of patients being treated at the inpatient unit of University Hospital Heidelberg, department for psychosomatic medicine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients of at least 18 years of age\n* included in inpatient psychotherapy treatment program in a hospital for psychosomatic medicine\n* provided measurements of symptoms, self-view, and group cohesion for at least one measurement occasion\n\nExclusion Criteria:\n\n* bipolar, acute psychotic or substance abuse disorder'}, 'identificationModule': {'nctId': 'NCT05594160', 'acronym': 'AGENTIC', 'briefTitle': 'Agentic Self-view as Common Factor in Psychotherapy - Self-efficacy in the Treatment of Inpatients Over the Course of Time', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Process Factors in Inpatient Psychotherapy', 'orgStudyIdInfo': {'id': 'Agency-Inpatient-2022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Patients treated at the inpatient psychotherapy unit of a University Hospital receive 8 to 10 weeks of multimodal psychotherapeutic treatment. Treatment consists of individual as well as group psychodynamic therapy. Additionally, patients receive an individual combination of music, art, relaxation and body-oriented group therapy. Therapeutic treatment is provided by a multiprofessional, interdisciplinary team of psychotherapists with either a medical or psychology degree, art and music therapists, specialist nurses, social workers and physiotherapists.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ulrike Dinger-Ehrenthal, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Medical Faculty, Heinrich-Heine University Düsseldorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared because study data is provided by mental health patients and is therefore subject to strict protection.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. phil. M. Sc.', 'investigatorFullName': 'Simone Jennissen', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}