complex mental health issues (F2x.x, F31.x, F43.x)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis: Confirmed diagnosis of a schizophrenia spectrum disorder (F2x.x), bipolar disorder (F31.x), or Post-Traumatic Stress Disorder (F43.1). Treatment Status: Individuals in the outpatient aftercare phase (typically following prior inpatient or day-clinic treatment). Technology: Access to an internet-enabled device (laptop, PC, tablet, or smartphone) and a stable internet connection. Consent: Provision of written informed consent after being fully informed. Language: Sufficient proficiency in the German language to follow the group sessions and learning modules.
Exclusion criteria
Exclusion criteria: Acute risk to self or others: Presence of acute suicidality or other acute safety concerns. Acute substance use disorder: Severe dependence on addictive substances that prevents regular participation or requires primary addiction treatment. Acute florid symptoms: Presence of acute symptoms so severe that participation in group sessions is impossible or requires urgent inpatient crisis intervention. Severe cognitive impairment: Impairments that prevent understanding of the program content or the ability to use the digital platform. Lack of consent: Individuals who are unable to understand the scope of the study or do not provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility (Adherence and Retention Rate): WHAT: Measurement of participation consistency and program completion. WHEN: Continuously throughout the 12-week program duration and at the final assessment (T2). HOW: Recording attendance in group sessions and analyzing platform usage data (e.g., login frequency, duration of module use, and interaction with modules). Acceptance Rate: WHAT: Evaluation of user acceptance of the digital program. WHEN: At the end of the intervention (T2). HOW: Analysis of software-based usage statistics and quantitative survey of acceptance. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following parameters are collected for comparison before the start (T1) and after completion (T2) of the 12-week intervention: Psychotic Symptomatology: WHAT: Assessment of positive, negative, and general symptoms. WHEN: T1 and T2. HOW: PANSS-14 (Positive and Negative Syndrome Scale; 14-item short version). Global Functioning: WHAT: Assessment of psychosocial functioning levels. WHEN: T1 and T2. HOW: GAF Scale (Global Assessment of Functioning). Psychological Distress: WHAT: Assessment of subjective clinical distress. WHEN: T1 and T2. HOW: BSCL (Brief Symptom Checklist). Subjective Quality of Life: WHAT: Measurement of health-related quality of life. WHEN: T1 and T2. HOW: WHOQOL (World Health Organization Quality of Life Instrument). Recovery Experience: WHAT: Assessment of the personal recovery process. WHEN: T1 and T2. HOW: RAS (Recovery Assessment Scale). Psychotic Experience: WHAT: Measurement of the frequency and intensity of psychotic experiences. WHEN: T1 and T2. HOW: CAPE (Community Assessment of Psychic Experiences). Self-reported Participation: WHAT: Assessment of social participation. WHEN: T1 and T2. HOW: Survey based on the ICF criteria (International Classification of Functioning, Disability and Health). Clinical Global Impression: WHAT: Assessment of illness severity and treatment progress. WHEN: T1 and T2. HOW: CGI Scale (Clinical Global Impression Scale). User Satisfaction and Subjective Impact: WHAT: Qualitative evaluation of user experience and perceived program effect. WHEN: T2. HOW: Qualitative assessment using a survey instrument specifically developed for this study. | — |
Countries
Germany
Contacts
Universitätsklinikum Köln