Mindfulness-based Group Therapy for Inpatients With Schizophrenia Spectrum Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- mindfulness
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Mindfulness-based group therapy (Behavioral)
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.
干预措施: Treatment as usual (Other)
结局指标
主要结局
mindfulness
时间窗: 6 months
The Freiburg Mindfulness Inventory (FMI) to measure mindfulness, 14 items on a scale from 1 - 4 (1 = seldom, 4 = almost always)
次要结局
- Symptoms - Depression and Anxiety(6 months)
- psychological flexibility(6 months)
- broad cognitive functioning(6 months)
- Symptom - Depression(6 months)
- personal and social performance(4 weeks)
- symptomatology - positive and negative symptoms(4 weeks)
- cognitive fusion(6 months)
- Quality of Life - domains assessed include physical and psychological health, social relationships and environment(6 months)
研究者
Kerem Böge
Principal Investigator
Charite University, Berlin, Germany