Mindfulness-based Group Therapy for Inpatients With Schizophrenia Spectrum Disorders

NCT ID: NCT03671005

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2021-02-28

Brief Summary

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.

Conditions

Psychotic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mindfulness-based group therapy (MBGT)

The mindfulness-based group therapy (MBGT) involves a four-week manual with three group therapy sessions per week in addition to TAU. The therapy represents the first German group-based mindfulness manual for psychosis. One sixty-minute session was held by a certified psychotherapist who is experienced in mindfulness-based therapy. A trained co-therapist implements two 30-minute sessions. On a weekly basis, a new theme is discussed in the three sessions to ensure the internalization of different mindfulness concepts. Namely, the topics Mindfulness of the Breath (1), Mindfulness of the Senses in the Context of Nature (2), Mindfulness of Detachment (3), and Mindfulness in the Context of Bodily Awareness (4) are addressed during the group-sessions.

Group Type: EXPERIMENTAL

Mindfulness-based group therapy

Intervention Type: BEHAVIORAL

see above

treatment as usual (TAU)

Treatment as usual (TAU) at the ward consists of a variety of daily activity groups the patients can choose from. Every patient at the ward receives a daily schedule depending on individual needs for therapy. The therapies offered at the ward include occupational therapy, physiotherapy, psychoeducative groups, and concentration practice of two levels, all not related to mindfulness interventions. In addition to the group activities at the ward, every patient receives individual psychotherapy sessions at least once a week, held by a certified psychiatrist or psychologist. Psychopharmacological treatment is provided by the physicians, and social workers are available in order to support patients in managing their everyday lives after the stationary treatment. Weekly group meetings at the ward, together with the treating physicians, psychotherapists, social workers and the respective patient, foster the exchange success and possible improvements of the treatment.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: OTHER

see above

Interventions

Mindfulness-based group therapy

see above

Intervention Type: BEHAVIORAL

Treatment as usual

see above

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• male and female participants
• treated as psychiatric inpatients at the psychosis - or social-psychiatric day ward
• between 18 and 65 years of age
• diagnosis of a schizophrenia-spectrum disorder according to the Diagnostical and Statistical Manual 5th edition) and the International Statistical Classification of Diseases and Related Health Problems(ICD-10) code F2
• ability to give informed consent
• willingness and ability to engage in psychotherapeutic group therapy
• low to moderate psychotic state indicated with a score of 6 < for each item at the Positive scale of the Positive and Negative Syndrome Scale (PANSS, Peralta & Cuesta, 1994)

Exclusion Criteria

• a score ≥ 6, suggesting an acute psychotic episode with severe psychotic symptoms (Peralta& Cuesta, 1994)
• acute suicidality, assessed by item eight of the Calgary Depression Scale for Schizophrenia > 1 (Addington, Addington, Maticka-Tyndale, & Joyce, 1992)
• any neurological disorders that may affect cognitive functioning
• acute substance abuse other than nicotine and prescribed medication

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Kerem Böge

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, , Germany

Countries

Germany

References

Boge K, Hahne I, Bergmann N, Wingenfeld K, Zierhut M, Thomas N, Ta TMT, Bajbouj M, Hahn E. Mindfulness-based group therapy for in-patients with schizophrenia spectrum disorders - Feasibility, acceptability, and preliminary outcomes of a rater-blinded randomized controlled trial. Schizophr Res. 2021 Feb;228:134-144. doi: 10.1016/j.schres.2020.12.008. Epub 2021 Jan 9.

Reference Type: DERIVED

PMID: 33434727 (View on PubMed)

Related Links

http://www.cambridgecognition.com/cantab/

app-based assessment

Other Identifiers

APS2018

Identifier Type: -

Identifier Source: org_study_id