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

NCT06086184 | Unknown

• 1 other identifier: Ethik-26/23
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale (PANSS)

  The primary endpoint symptom severity is assessed using the German version of the established Positive and Negative Syndrome Scale (PANSS). The PANSS consists of a third-party assessment interview in which 30 symptoms are rated using a seven-point scale ranging from 1 (nonexistent) to 7 (extreme symptom). Symptoms are assigned to three scales: The Positive Scale, the Negative Scale, and the General Psychopathology Scale. The PANSS is widely used and is considered the gold standard for assessing psychopathology in people with psychotic disorders because of its good reliability and validity.

  T0 Baseline Examinations: Before the start of the intervention at study enrollment T1 Final examinations: After the end of the four-week intervention (week 5) T2 Follow-up examinations: 6 months after the end of the intervention

Secondary Outcomes (7)

• Global Assessment of Functioning (GAF)

  T0 Baseline Examinations: Before the start of the intervention at study enrollment T1 Final Examinations: After the end of the four-week intervention (week 5) T2 Follow-up Examinations: 6 months after the end of the intervention

• World Health Organization Quality of Life Brief Version (WHOQOL-BREF)

  T0 Baseline Examinations: Before the start of the intervention at study enrollment T1 Final Examinations: After the end of the four-week intervention (week 5) T2 Follow-up Examinations: 6 months after the end of the intervention

• Fragebogen für Akzeptanz und Handeln (FAH-II)

  T0 Baseline Examinations: Before the start of the intervention at study enrollment T1 Final Examinations: After the end of the four-week intervention (week 5) T2 Follow-up Examinations: 6 months after the end of the intervention

• Fragebogen zur Messung der Patientenzufriedenheit (ZUF-8)

  T1 Final Examinations: After the end of the four-week intervention (week 5)

• Questionnaire about the Process of Recovery (QPR)

  T0 Baseline Examinations: Before the start of the intervention at study enrollment T1 Final Examinations: After the end of the four-week intervention (week 5) T2 Follow-up Examinations: 6 months after the end of the intervention

Other Outcomes (4)

• Number of group therapy sessions attended and drop out rate

  Therapy attendance during the four-week intervention will be measured at T1 Final Examinations after the end of the four-week intervention (week 5).

• Qualitative semi-structured interview analysis according to Mayring

  T1 Final Examinations: After the end of the four-week intervention (week 5).

• WHO Alcohol, Smoking and Substance Involvement Screening Test (WHO ASSIST)

  T0 Baseline Examinations: Before the start of the intervention at study enrollment T2 Follow-up Examinations: 6 months after the end of the intervention

Study Arms (1)

ACT group therapy

EXPERIMENTAL

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

Behavioral: ACT group therapy

Interventions

ACT group therapy 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.

ACT group therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Vivantes Netzwerk für Gesundheit GmbH: lead

Study Sites (1)

Vivantes Klinikum Am Urban

Kreuzberg, State of Berlin, 10967, Germany

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Andreas Bechdolf, Prof. Dr.

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

  STUDY DIRECTOR

Central Study Contacts

Andreas Bechdolf, Prof. Dr.

CONTACT

+4930130226001; andreas.bechdolf@vivantes.de

Felicitas Ehlen, Dr.

CONTACT

+4930130226001; felicitas.ehlen@vivantes.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Psychiatry Vivantes Klinikum Am Urban and Klinikum im Friedrichshain

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 17, 2023
• Study Start: October 16, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

DE (1)