Inpatient PsychotherapyAGENTICNCT05594160
Agentic Self-view as Common Factor in Psychotherapy - Self-efficacy in the Treatment of Inpatients Over the Course of Time
An observational study of Inpatient Psychotherapy and Self Efficacy, run by University Hospital Heidelberg.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inpatient Psychotherapy, Self Efficacy, Group Cohesion
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,544 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jun 2021
- How long will I take part?
- 10 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients being treated at the inpatient unit of University Hospital Heidelberg, department for psychosomatic medicine.
Who may be able to join
- 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
Who cannot join
- bipolar, acute psychotic or substance abuse disorder
About this study
Official title: 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.
Read the 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.
- Being tested
- Psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Checklist Short Form (SCL-K11)
Symptom measure assessing depressive and anxiety related symptoms with 11 items
Measured: 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
Subscale assessing patients' sense of themselves by measuring self-efficacy and self-evaluation
Measured: 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
Subscale assessing the quality of the relationships between patients in an inpatient psychotherapy program
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study startJul 2015
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inpatient PsychotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,544 participants (actual)
- Target duration
- 10 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Jennissen, University Hospital Heidelberg
- Investigators
- Ulrike Dinger-Ehrenthal, Prof. Dr., Study director, Department of Psychosomatic Medicine and Psychotherapy, Medical Faculty, Heinrich-Heine University Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594160
- Sponsor's protocol ID
- Agency-Inpatient-2022
- Acronym
- AGENTIC
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because study data is provided by mental health patients and is therefore subject to strict protection.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Process Factors in Inpatient Psychotherapy
- ClinicalTrials.gov ID
- NCT05594160
- Acronym / sponsor ID
- AGENTIC / Agency-Inpatient-2022
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,544 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients being treated at the inpatient unit of University Hospital Heidelberg, department for psychosomatic medicine.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- bipolar, acute psychotic or substance abuse disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychotherapyPatients 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. | Behavioural | – |
Primary outcome
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
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because study data is provided by mental health patients and is therefore subject to strict protection.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Dinger-Ehrenthal, Prof. Dr. study director
Department of Psychosomatic Medicine and Psychotherapy, Medical Faculty, Heinrich-Heine University Düsseldorf
Questions about this trial
What is this clinical trial studying?
An observational study of Inpatient Psychotherapy and Self Efficacy, run by University Hospital Heidelberg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.