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Intervention for the Treatment of Depression in Virtual Reality (FlowVR)

Intervention for the Treatment of Depression in Virtual Reality (FlowVR) - FlowVR

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034078
Enrollment
66
Registered
2024-04-25
Start date
2024-05-13
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

F32 F32.1 F32.2 F32.8 F32.9 F33 F33.1 F33.2 F33.8 F33.9

Interventions

Group 1: FlowVR: The group sessions take place once a week over a period of four weeks. The FlowVR intervention group consists of a group of three participants each. In FlowVR, participants fly throug

Sponsors

Asklepois Klinikum Harburg Zentrum für seelische Gesundheit Klinik für Psychiatrie, Psychotherapie und Psychosomatik
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Meeting the criteria for Major Depression, Dysthymia, or Recurrent Depressive Disorder according to DSM-5 verified (M.I.N.I.) with current episode, proficient in German language, providing written consent for study participation and the ability to give informed consent.

Exclusion criteria

Exclusion criteria: Patients with psychosis (including affective disorder with psychotic features), bipolar disorder, post-traumatic stress disorder, acute suicidality, and substance use disorder (currently not abstinent), as well as (partial) inpatient psychotherapy during the study.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the change in mindfulness from T0 to T1 and from T0 to T2 (secondary), which is measured by using the Five Facet Mindfulness Questionnaire (FFMQ-D).

Secondary

MeasureTime frame
Hamilton Depression Scale: The Hamilton Depression Scale is an expert rating for assessing the severity of depressive symptoms (T0, T1 and T2). Cognitive Failure Questionnaire (CFQ): The CFQ is a self-rating to assess individual differences in subjective experiences of cognitive performance (T0, T1 and T2). Beck Depression Inventory-II (BDI-II): Self-rating questionnaire to assess depressive symptoms (T0, T1 and T2). Rosenberg Self-Esteem Scale (RSES): The RSES is a self-report questionnaire that assesses self-esteem (T0, T1 and T2). Quality of life - Globalitem (WHO-QOL-BREF): Global item WHO-QOL-BREF is a self-rating and measures quality of life (T0, T1 and T2). Skala zur Allgemeinen Selbstwirksamkeitserwartung (SWE): The SWE is a self-rating for recording one's own self-efficacy expectation (T0, T1 and T2). Subjective evaluation (based on a questionnaire by Miegel et al. [2023]): Self-assessment questionnaire, records the subjective appraisal of FlowVR (T1). Side effect questionnaire based on the Positive and Negative Effect Questionnaire with VR-specific items (PANEPS-VR): The PANEPS-VR is based on the PANEPS (Moritz et al., 2019) and is a self-rating for recording positive and negative side effects, which was adapted and supplemented with VR-specific items (T1). Pre- and post-session questionnaire (PPSQ): The pre- and post-session questionnaire is a self-rating and assesses different aspects like for example motivation, self-efficacy, mindfulness, and group cohesion (before and after each session). State-Trait-Anxiety-Depression-Inventory (STADI[S]): Self-assessment instrument for recording anxiety and depression at the status level (before and after each session). We will only assess state anxiety and depression. Simulator Sickness Questionnaire (SSQ): Self-assessment tool that records discomfort (e.g., nausea) in virtual reality (before and after each session). Flow Short Scale (FSS): Captures the flow experience in virtual reality (befo

Countries

Germany

Contacts

Public ContactLuzie Lohse

Asklepois Klinikum Harburg Zentrum für seelische Gesundheit Klinik für Psychiatrie, Psychotherapie und Psychosomatik

l.lohse@asklepios.com040 1818863243

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026