Mindfulness-based Group Therapy for Inpatients With Schizophrenia Spectrum Disorders

NCT03671005 | Terminated

• 1 other identifier: APS2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• mindfulness

  The Freiburg Mindfulness Inventory (FMI) to measure mindfulness, 14 items on a scale from 1 - 4 (1 = seldom, 4 = almost always)

  6 months

• mindfulness

  Comprehensive Inventory of mindfulness experience (CHIME, 37 items on a scale from 1 (almost never) to 6 (almost always)

  6 months

• mindfulness

  Southampton mindfulness questionnaire (SMQ), 16 items on a scale from 1 (applies fully) to 7 (does not apply at all)

  6 months

Secondary Outcomes (8)

• broad cognitive functioning

  6 months

• personal and social performance

  4 weeks

• Symptom - Depression

  6 months

• symptomatology - positive and negative symptoms

  4 weeks

• Symptoms - Depression and Anxiety

  6 months

Study Arms (2)

Mindfulness-based group therapy (MBGT)

EXPERIMENTAL

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.

Behavioral: Mindfulness-based group therapy

treatment as usual (TAU)

ACTIVE COMPARATOR

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.

Other: Treatment as usual

Interventions

Mindfulness-based group therapy BEHAVIORAL

see above

Mindfulness-based group therapy (MBGT)

Treatment as usual OTHER

see above

treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, 1220, Germany

Location

Related Publications (1)

• 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.

  PMID: 33434727 DERIVED

Related Links

• app-based assessment

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded psychiatrist who works independently of the (co-) therapist conducts the rater-questionnaires. Due to the psychotherapeutic nature of the study, information about the treatment allocation has to be shared with the co-therapist and the participants. Randomization is conducted by the Random Group Generator (pubmed, 2018).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single-centered randomized controlled trial with a parallel-groups design is utilized, comprising of mindfulness-based group therapy (MBGT) in addition to treatment as usual (TAU) in the experimental condition, and TAU in the control condition

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 14, 2018
• Study Start: May 1, 2018
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)