NCT05594160

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,544

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

5.9 years

First QC Date

October 21, 2022

Last Update Submit

October 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Symptom Checklist Short Form (SCL-K11)

    Symptom measure assessing depressive and anxiety related symptoms with 11 items

    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.

Secondary Outcomes (2)

  • Inpatient and day clinic experiences questionnaire (IDES) - Subscale Positive Self

    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.

  • Inpatient and day clinic experiences questionnaire (IDES) - Subscale Group Cohesion

    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.

Interventions

PsychotherapyBEHAVIORAL

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients being treated at the inpatient unit of University Hospital Heidelberg, department for psychosomatic medicine.

You may qualify if:

  • patients of at least 18 years of age
  • included in inpatient psychotherapy treatment program in a hospital for psychosomatic medicine
  • provided measurements of symptoms, self-view, and group cohesion for at least one measurement occasion

You may not qualify if:

  • bipolar, acute psychotic or substance abuse disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Psychotherapy

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Ulrike Dinger-Ehrenthal, Prof. Dr.

    Department of Psychosomatic Medicine and Psychotherapy, Medical Faculty, Heinrich-Heine University Düsseldorf

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. phil. M. Sc.

Study Record Dates

First Submitted

October 21, 2022

First Posted

October 26, 2022

Study Start

July 1, 2015

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because study data is provided by mental health patients and is therefore subject to strict protection.