Psychotic DisordersASPIRENCT06086184
Inpatient Group Acceptance and Commitment Therapy (ACT) for Psychosis Spectrum Disorder
A study testing ACT group therapy in people with Psychotic Disorders and Acceptance and Commitment Therapy, run by Vivantes Netzwerk für Gesundheit GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychotic Disorders, Acceptance and Commitment Therapy, Psychotherapy, Group
- What is being tested?
- ACT group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 16 Oct 2023to Feb 2025
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Psychotic disorder due to another disorder
- Substance-induced/medication-induced psychotic disorder
- Depressive episode with psychotic symptoms
- Manic or bipolar episode with psychotic symptoms
Who cannot join
- Patients decline to participate in the treatment program
- Language or intellectual abilities insufficient for study participation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Vivantes Klinikum Am Urban
Kreuzberg, State of Berlin, 10967
Andreas Prof. Dr. Bechdolf
Felicitas Dr. Ehlen
About this study
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
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.
Read the 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.
- Being tested
- ACT group therapy
- Keywords
- Mindfulness, Acceptance and Commitment Therapy, Psychotherapy, Group, Inpatients, Psychotic Disorders
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT group therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ACT group therapy | Experimental | High-frequency inpatient ACT group therapy program for patients with psychosis spectrum disorder. Receives: Behavioral: ACT group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The general level of functioning is assessed using the German version of the Global Assessment of Functioning (GAF) numerical external assessment scale. The GAF is divided into 10 levels of functioning with 10 points each and ranges from 100 (highest level of functioning) to 1 (lowest level of functioning). Environmental conditions and physical illness are explicitly not to be considered here. Mental, social, and occupational functioning are thought of as being on a hypothetical continuum from mental health to illness.
Measured: 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)
Quality of life is measured with the German version of the WHOQOL-BREF (World Health Organization Quality of Life Brief Version), an abbreviated version of the WHOQOL-100 (World Health Organization Quality of Life 100). The WHOQOL-BREF, which is a brief self-report instrument, consists of a total of 26 items, which are assigned to the 4 domains of physical health (7 items), psychological health (6 items), social relationships (3 items) and environmental health (8 items). Two other items measure overall quality of life and general health. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale (low score of 1 to high score of 5). The average score for each domain is calculated, resulting in an average domain score between 4 and 20. This average domain score is multiplied by 4 to transform it into a scaled score, with a higher score indicating a better quality of life.
Measured: 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)
German version of the Acceptance and Action Questionnaire (AAQ-II). The AAQ-II was developed to measure experience avoidance based on the model of psychological flexibility. It consists of a 7-point Likert scale. Participants rated between 1 (never true) and 7 (always true) how well the statements describe them. The range of scores is between 7 and 49. Higher scores on the scale indicate higher experience avoidance and lower psychological flexibility.
Measured: 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)
Patient satisfaction at the end of the intervention is assessed using the German version of the self-report scale Client Satisfaction Questionnaire CSQ-8, the ZUF-8 (Questionnaire for the Measurement of Patient Satisfaction). The eight items are formulated as questions and each have four response options, for which 1-4 points are assigned. After reversal of polarity, all eight item values are summed up to the scale value ZUF-8 (theoretical scale range from 8 to 32). High scale values indicate a high level of "satisfaction", low scale values indicate a low level of "satisfaction".
Measured: T1 Final Examinations: After the end of the four-week intervention (week 5)
Questionnaire about the Process of Recovery (QPR)
The German version of the self-report scale Questionnaire about the Process of Recovery (QPR), the Personal Recovery Questionnaire, serves as an instrument for assessing personal recovery. The QPR comprises 15 items, each of which is rated on a 4-point scale (0 = do not agree at all, 1 = do not agree , 2 = partly agree, 3 = agree, 4 = fully agree ) and has been validated in German.
Measured: 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
Comprehensive Inventory of Mindfulness Experiences (CHIME)
Mindfulness skills are assessed with the German self-report scale Comprehensive Inventory of Mindfulness Experiences (CHIME). CHIME is a questionnaire for self-assessment of different aspects of mindfulness. It comprises 37 items that are assigned to eight subscales. Items are scored on a 5-point Likert scale ranging from 1 (never) to 5 (very often). The higher the the arithmetic mean the better the mindfulness skills.
Measured: 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
Cognitive Fusion Questionnaire (CFQ-D)
Cognitive fusion is assessed with the German version of the self-report questionnaire Cognitive Fusion Questionnaire (CFQ). The Cognitive Fusion Questionnaire (CFQ) assesses cognitive fusion, or rigidly following self-generated rules. The CFQ is a 7 item self-report instrument with a range of 7-49. Higher scores are indicative of a higher level of cognitive fusion.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start16 Oct 2023
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vivantes Netzwerk für Gesundheit GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Andreas Bechdolf, Vivantes Netzwerk für Gesundheit GmbH
- Investigators
- Andreas Bechdolf, Prof. Dr., Study director, Senior consultant department of psychiatry Vivantes Klinikum Am Urban and Klinikum im Friedrichshain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086184
- Sponsor's protocol ID
- Ethik-26/23
- Acronym
- ASPIRE
- Status last verified
- Nov 2023
- First submitted
- 5 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06086184
- Acronym / sponsor ID
- ASPIRE / Ethik-26/23
- Keywords
- Mindfulness, Acceptance and Commitment Therapy, Psychotherapy, Group, Inpatients, Psychotic Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Vivantes Netzwerk für Gesundheit GmbHUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 17 Oct 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACT group therapy | Experimental | Behavioral: ACT group therapyHigh-frequency inpatient ACT group therapy program for patients with psychosis spectrum disorder. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- Patients decline to participate in the treatment program
- Language or intellectual abilities insufficient for study participation
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 |
|---|---|---|
| ACT group therapyParticipation 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. | Behavioural | ACT group therapy |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: 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
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.
7 secondary outcomes
Global Assessment of Functioning (GAF)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: T1 Final Examinations: After the end of the four-week intervention (week 5)
Questionnaire about the Process of Recovery (QPR)
Time frame: 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
Comprehensive Inventory of Mindfulness Experiences (CHIME)
Time frame: 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
Cognitive Fusion Questionnaire (CFQ-D)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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.
Andreas Bechdolf, Prof. Dr. study director
Senior consultant department of psychiatry Vivantes Klinikum Am Urban and Klinikum im Friedrichshain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT group therapy in people with Psychotic Disorders and Acceptance and Commitment Therapy, run by Vivantes Netzwerk für Gesundheit GmbH at 1 site in Germany.
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 10 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Bechdolf, Prof. Dr. (+4930130226001, andreas.bechdolf@vivantes.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (PANSS) (time frame: 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). 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 18 Nov 2023.