NCT03671005

Mindfulness-based Group Therapy for Inpatients With Schizophrenia Spectrum Disorders

Terminated NA Last updated 9 February 2023

What this trial tests

NA trial testing Mindfulness-based group therapy in Psychotic Disorder in 40 participants. Terminated before completion.

Timeline

1 May 2018

Primary endpoint
28 February 2021

28 February 2021

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	1 May 2018
Primary completion	28 February 2021
Estimated completion	28 February 2021
Sites	1 location across Germany

Drugs / interventions tested

• Mindfulness-based group therapy
• Treatment as usual

Conditions studied

• Psychotic Disorder — all drugs for Psychotic Disorder →

Sponsor

Charite University, Berlin, Germany

Who can join

Adults 18 to 65, any sex, with Psychotic Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A single-centered randomized controlled trial with a parallel-groups design is utilized, comprised of mindfulness-based group therapy (MBGT) in the experimental condition, and treatment as usual (TAU) in the control condition. Participants in the experimental condition continued their regular psychiatric treatment (TAU) next to the participation in the MBGT. In order to evaluate possible psychotherapeutic effects, self-report and other clinical questionnaires including interviews and app-based assessments are evaluated before (T0), and after the four-week intervention (T1).

Ward psychiatrists identify eligible participants and invite them to participate in the study. An eligibility screening is held by the study assistant at baseline, introducing the study, providing informed consent in written form, as well as conducting the self-report measures and app-based assessments. A blinded psychiatrist who works independently of the (co-) therapist conducts the remaining rater-questionnaires. Due to the psychotherapeutic nature of the study, information about the treatment allocation had to be shared with the co-therapist and the participants. Randomization was conducted by the Random Group Generator (pubmed, 2018). The data management plan includes standard procedures for data-handling such as using anonymized identification codes for patient data. The participants have the right to access their data, and the right to claim an annihilation. The data is being stored in locked cupboards, only allowing researchers involved in the study to access the data.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mindfulness-based group therapy for in-patients with schizophrenia spectrum disorders - Feasibility, acceptability, and preliminary outcomes of a rater-blinded randomized controlled trial.
   Böge K, Hahne I, Bergmann N, Wingenfeld K, et al · · 2021 · cited 23× · PMID 33434727 · DOI 10.1016/j.schres.2020.12.008
2. Home practice in mindfulness-based interventions for psychosis groups: a systematic review and qualitative study.
   Jacobsen P, Choksi T, Sawyer K, Maximen C, et al · · 2022 · cited 4× · PMID 35022085 · DOI 10.1186/s40359-021-00694-4
3. The relationship between mindfulness, psychological flexibility, and symptom severity in persons with schizophrenia-spectrum-disorders: a cross-sectional study.
   Hahne I, Segerer J, Zierhut M, Bergmann N, et al · · 2025 · cited 1× · PMID 40467751 · DOI 10.1038/s41598-025-03380-2