NCT07841418Not yet recruiting
Psychotherapy for Self-Disorders in Schizophrenia Spectrum Disorder
Psychotherapy for Abnormalities of Self-VITALITY in Patients With Schizophrenia Spectrum Disorder: A Feasibility RCT [VITALIZE]
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
The primary goal of the VITALIZE study is to evaluate the feasibility of SELF-7, a novel phenomenologically informed psychotherapy for self-disorders, as an add-on to standard psychiatric outpatient treatment - Flexible Assertive Community Treatment (F-ACT) - in adults with schizophrenia spectrum disorders. The main question is whether SELF-7 is feasible and acceptable in routine psychiatric outpatient care (F-ACT teams). A secondary objective of the study is to explore whether SELF-7 may reduce psychological distress related to self-disorders and improve personal recovery, well-being, functioning, perceived stress, suicidal ideation, symptom severity, insight, and self-disorders. Researchers will compare SELF-7 plus F-ACT with F-ACT alone. Participants will be randomized to one of the two groups, complete clinical interviews and questionnaires at baseline, 16 weeks, and 26 weeks, and, if allocated to SELF-7, receive 12 individual psychotherapy sessions in addition to standard care (F-ACT).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 6 Sept 2026
- Start date
- 15 Sept 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Psychiatric Research Unit, Region Zealand, Denmark
- Diseases
- Schizophrenia
- NCT number
- NCT07841418
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 15 Sept 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current forensic psychiatric status.
- Severe comorbid somatic illness or severe comorbid psychiatric disorder that substantially compromises the ability to participate in psychotherapy.
Other
- Insufficient proficiency in Danish to participate in psychotherapy and complete study assessments.
- Current severe alcohol or substance dependence.
- Clinically assessed elevated risk of severe self-harm, suicide, or harm to others.
- Not deemed able to participate in psychotherapy based on clinical judgment.
Who the study is looking for
- Age ≥18 years.
- Capacity to understand study procedures and provide written informed consent.
- ICD-10 diagnosis of schizophrenia (F20.x) or schizotypal disorder (F21).
- Receiving treatment in a Flexible Assertive Community Treatment (F-ACT) team.
- Discharged from the OPUS early intervention outpatient programme within the past 5 years.
- Clinically stable with regard to antipsychotic treatment (receiving antipsychotic medication or not receiving antipsychotic medication) and with no planned substantial changes in antipsychotic treatment at the time of inclusion.
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Psychiatric Research Unit, Mental Health Services Region Zealand Coordinator of this site? Confirm its status | Slagelse | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.