Clinical trial NCT06086184: Inpatient Group Acceptance and Commitment Therapy (ACT) for Psychosis Spectrum Disorder
Official title: Pilot Study to Evaluate the Effectiveness of an Acceptance and Commitment Therapy (ACT)-Based Treatment Approach With Inpatient Group Therapy Interventions for Patients With Psychosis Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychotic Disorders
Acceptance and Commitment Therapy
Psychotherapy, Group
Inpatients
Keywords: Mindfulness
Acceptance and Commitment Therapy
Psychotherapy, Group
Inpatients
Psychotic Disorders
Lead sponsor: Vivantes Netzwerk für Gesundheit GmbH
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 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:
measure: Global Assessment of Functioning (GAF)
timeFrame: 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
measure: World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
timeFrame: 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
measure: Fragebogen für Akzeptanz und Handeln (FAH-II)
timeFrame: 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
measure: Fragebogen zur Messung der Patientenzufriedenheit (ZUF-8)
timeFrame: T1 Final Examinations: After the end of the four-week intervention (week 5)
measure: Questionnaire about the Process of Recovery (QPR)
timeFrame: 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
measure: Comprehensive Inventory of Mindfulness Experiences (CHIME)
timeFrame: 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
measure: Cognitive Fusion Questionnaire (CFQ-D)
timeFrame: 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:
measure: Number of group therapy sessions attended and drop out rate
timeFrame: Therapy attendance during the four-week intervention will be measured at T1 Final Examinations after the end of the four-week intervention (week 5).
measure: Qualitative semi-structured interview analysis according to Mayring
timeFrame: T1 Final Examinations: After the end of the four-week intervention (week 5).
measure: WHO Alcohol, Smoking and Substance Involvement Screening Test (WHO ASSIST)
timeFrame: T0 Baseline Examinations: Before the start of the intervention at study enrollment T2 Follow-up Examinations: 6 months after the end of the intervention
measure: ACT Fidelity Measure (ACT-FM)
timeFrame: ACT Fidelity Measure will be evaluated during the four-week intervention.
Locations:
city: Berlin-Kreuzberg
country: Germany
facility: Vivantes Klinikum Am Urban
state: Berlin
Study officials:
affiliation: Senior consultant department of psychiatry Vivantes Klinikum Am Urban and Klinikum im Friedrichshain
name: Andreas Bechdolf, Prof. Dr.
role: STUDY_DIRECTOR
References: