Agentic Self-view as Common Factor in Psychotherapy - Self-efficacy in the Treatment of Inpatients Over the Course of Time (AGENTIC)

October 21, 2022 updated by: Simone Jennissen, University Hospital Heidelberg

Process Factors in Inpatient Psychotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

For 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.

To 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.

Thus, 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.

Study Type

Observational

Enrollment (Actual)

1544

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • bipolar, acute psychotic or substance abuse disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Checklist Short Form (SCL-K11)
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inpatient and day clinic experiences questionnaire (IDES) - Subscale Positive Self
Time Frame: 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.
Subscale assessing patients' sense of themselves by measuring self-efficacy and self-evaluation
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
Time Frame: 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.
Subscale assessing the quality of the relationships between patients in an inpatient psychotherapy program
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Investigators

  • Study Director: Ulrike Dinger-Ehrenthal, Prof. Dr., Department of Psychosomatic Medicine and Psychotherapy, Medical Faculty, Heinrich-Heine University Düsseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

October 21, 2022

First Submitted That Met QC Criteria

October 21, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 21, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Agency-Inpatient-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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