Implementation of the patient version of the evidence-based (S3) guideline for psychosocial interventions for patients with severe mental illness (IMPPETUS): a cluster randomised controlled study

Implementation of the patient version of the evidence-based (S3) guideline for psychosocial interventions for patients with severe mental illness (IMPPETUS): a cluster randomised controlled study - IMPPETUS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017577

Enrollment

500

Registered

2019-10-23

Start date

2019-10-28

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F20-F29 F30-F39

Interventions

Group 1: Multimodal implementation of the patient-guideline "Psychosocial interventions for patients with severe mental illness". Group 2: Treatment as usual + Information flyer for the patient-guidel

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inpatients and day hospital patients; patients with schizophrenia, schizotypal and delusional disorders (ICD-10 F2x) or Mood [affective] disorders (ICD-10 F3x); disease duration of = 2 years; considerable consequences on activities of daily life (‘Global Assessment of Functioning’ (GAF) score = 60 and a ‘Health of the Nation Outcome Scales’ (HoNOS) Score of = 2 on one of the items of the subscale for symptomatic problems (item 6, 7, and 8) and a score of = 2 on each of the four items of the subscale for social problems (items 9, 10, 11, and 12) or a score of = 3 on at least one of these items (9, 10, 11, or 12)) // relatives of patients with mental disorders: both sexes, age >= 18 years

Exclusion criteria

Exclusion criteria: Patients and relatives who are not able to consent; Patients and relatives who are unable to understand answer the questions/study; Relatives when they are in inpatient or day hospital mental health care

Design outcomes

Primary

Measure	Time frame
The primary outcome is the change of empowerment after 6 month, which will be measured using the 'empowerment in the process of psychiatric treatment of patients with affective and schizophrenia disorders (EPAS)' scale.	—

Secondary

Measure	Time frame
(1) Changes in participants' knowledge, attitudes, and experiences regarding available treatments will be assessed using a checklist developed for this study, listing all psychosocial interventions of the S3 guideline ‘psychosocial interventions’. Measurement at t0 (baseline), t1 (post-intervention), t2 (6 month after baseline). (2) Changes in service use will be measured using the 'Client Sociodemographic and Service Receipt Inventory’ (CSSRI). Measurement at t0, t2. (3) A higher satisfaction with treatment will be assessed using the German satisfaction questionnaire ‘ZUF-8’. Measurement at t0, t1 , t2. (4) Changes in treatment needs and coverage of needs of the patients will be assessed by using the ‘Camberwell Assessment of Need’ (CAN-EU). Measurement at t0, t2. (5) An improvement of the Quality of life (QOL) will be measured using the World Health Organization’s Quality of Life Instrument-abbreviated version (WHOQOL-BREF). Measurement at t0, t2. (6) The calculation of quality-adjusted life years (QALY) will be based on the EuroQol (EQ-5D-5L). Measurement at t0, t2. (7) In addition, the participation and social inclusion of the patients will be assessed using the German questionnaire ‘Fragebogen zur Erfassung sozialer Partizipation und sozialer Inklusion chronisch psychisch erkrankter Menschen’ (F-INK). Measurement at t0, t2. (8) Sociodemographic data (e.g. sex, age, and socioeconomic data) and patient’s medical history will be assessed within the CSSRI.	—

Measure

Time frame

(1) Changes in participants' knowledge, attitudes, and experiences regarding available treatments will be assessed using a checklist developed for this study, listing all psychosocial interventions of the S3 guideline ‘psychosocial interventions’. Measurement at t0 (baseline), t1 (post-intervention), t2 (6 month after baseline). (2) Changes in service use will be measured using the 'Client Sociodemographic and Service Receipt Inventory’ (CSSRI). Measurement at t0, t2. (3) A higher satisfaction with treatment will be assessed using the German satisfaction questionnaire ‘ZUF-8’. Measurement at t0, t1 , t2. (4) Changes in treatment needs and coverage of needs of the patients will be assessed by using the ‘Camberwell Assessment of Need’ (CAN-EU). Measurement at t0, t2. (5) An improvement of the Quality of life (QOL) will be measured using the World Health Organization’s Quality of Life Instrument-abbreviated version (WHOQOL-BREF). Measurement at t0, t2. (6) The calculation of quality-adjusted life years (QALY) will be based on the EuroQol (EQ-5D-5L). Measurement at t0, t2. (7) In addition, the participation and social inclusion of the patients will be assessed using the German questionnaire ‘Fragebogen zur Erfassung sozialer Partizipation und sozialer Inklusion chronisch psychisch erkrankter Menschen’ (F-INK). Measurement at t0, t2. (8) Sociodemographic data (e.g. sex, age, and socioeconomic data) and patient’s medical history will be assessed within the CSSRI.

—

Countries

Germany

Contacts

Public ContactJohanna Breilmann

Universität Ulm, Klinik für Psychiatrie und Psychotherapie II, BKH Günzburg

johanna.breilmann@uni-ulm.de+49 8221 96-29204

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 28, 2026