Inpatient Group Acceptance and Commitment Therapy (ACT) for Psychosis Spectrum Disorder

NCT ID: NCT06086184

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2025-02-28

Brief Summary

The pilot study that will serve as the basis for the larger project - a multicenter randomized controlled single-blinded trial (RCT) will focus on testing the feasibility and efficacy of an inpatient group ACT treatment program and its effects on symptom severity and patient satisfaction in patients with psychosis spectrum disorder. The ACT-specific treatment program for inpatients with psychosis spectrum disorder is designed to enable patients to deal with their disease in an accepting manner over the long term, to promote self-determined and positive attitudes toward treatment and support options, and thus to reduce rehospitalization rates.

Detailed Description

Inpatient hospitalization is an important time to provide patients with psychosis spectrum disorder with skills to better manage symptoms and improve functioning after discharge. The long-term goal is to reduce the negative consequences of these disorders and to have a lasting positive impact on the course of the disease. Against this background, the aim of a larger-scale future study project is to evaluate a specific ACT-based four-week treatment program providing inpatient group therapy interventions for patients with psychosis spectrum disorder. The ACT-specific treatment program is designed to enable patients to deal with their disease in an accepting manner over the long term, to promote self-determined and positive attitudes toward treatment and support options, and thus to reduce rehospitalization rates. The pilot study will focus on testing the feasibility and efficacy of the inpatient group ACT treatment program and its effects on symptom severity and patient satisfaction in patients with psychosis spectrum disorder. Here, treatment will include a high-frequency four-week inpatient ACT group therapy program with a focus on the core ACT process of mindfulness in addition to standard inpatient treatment. Within the scope of the survey, possible side effects of the intervention will also be recorded and mapped by conducting qualitative individual interviews and documenting serious adverse events.

Conditions

Psychotic Disorders; Acceptance and Commitment Therapy; Psychotherapy, Group; Inpatients

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACT group therapy

High-frequency inpatient ACT group therapy program for patients with psychosis spectrum disorder.

Group Type: EXPERIMENTAL

ACT group therapy

Intervention Type: BEHAVIORAL

Participation in four sessions of the inpatient "Compass Group" and eight sessions of the inpatient "Here-and-Now Group". This should be completed within four weeks and may be completed within six weeks in exceptional cases. The groups are designed as a semi-open group with one therapist and one cotherapist each and are integrated into the existing therapy plan.

Interventions

ACT group therapy

Participation in four sessions of the inpatient "Compass Group" and eight sessions of the inpatient "Here-and-Now Group". This should be completed within four weeks and may be completed within six weeks in exceptional cases. The groups are designed as a semi-open group with one therapist and one cotherapist each and are integrated into the existing therapy plan.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients with psychosis spectrum disorder with the following diagnoses according to the Diagnostic and Statistical Manual Diploma in Social Medicine 5 ("Schizophrenia Spectrum and Other Psychotic Disorders"):
• Schizophrenia
• Schizophreniform disorder
• Schizoaffective disorder
• Delusional disorder
• Brief psychotic disorder
• Psychotic disorder due to another disorder
• Substance-induced/medication-induced psychotic disorder
• Depressive episode with psychotic symptoms
• Manic or bipolar episode with psychotic symptoms

Exclusion Criteria

• Patients decline to participate in the treatment program
• Language or intellectual abilities insufficient for study participation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vivantes Netzwerk für Gesundheit GmbH

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Andreas Bechdolf

Head of Psychiatry Vivantes Klinikum Am Urban and Klinikum im Friedrichshain

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Bechdolf, Prof. Dr.

Role: STUDY_DIRECTOR

Senior consultant department of psychiatry Vivantes Klinikum Am Urban and Klinikum im Friedrichshain

Locations

Vivantes Klinikum Am Urban

Kreuzberg, State of Berlin, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Andreas Bechdolf, Prof. Dr.

Role: CONTACT

andreas.bechdolf@vivantes.de

+4930130226001

Felicitas Ehlen, Dr.

Role: CONTACT

felicitas.ehlen@vivantes.de

+4930130226001

Facility Contacts

Andreas Prof. Dr. Bechdolf

Role: primary

Felicitas Dr. Ehlen

Role: backup

Other Identifiers

Ethik-26/23

Identifier Type: -

Identifier Source: org_study_id