Investigation of the Effects of Family-Focused Therapy in the Early Period of Bipolar Disorder and Psychotic Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The change from Personal and Social Performance Scale (PSP) scores
研究概览
简要总结
Family-focused therapy (FFT) is a comprehensive therapy approach applied to individuals and their families. In the present study, the researchers aimed to investigate the effects of family-focused therapy (FFT) in the early stages of psychotic disorder and bipolar disorder, regarding the psychiatric symptomatology, family communication skills, coping capacities, family burden and quality of life. A total of 34 young people diagnosed with bipolar disorder (BD) and 17 psychotic disorders (PD) will be included in the study.
详细描述
In this study, the researcher's primary goal is to investigate the effects of family-focused therapy sessions on young people aged between 15 and 21. Subjects were referred to an early intervention center for psychotic and bipolar disorders. The target population of the study consists of the patients in remission after the episode of the illness.
Therapy sessions will be conducted in line with the manual for "Family Focused Therapy for High-Risk Adolescents and Young Adults for Bipolar Disorder or Psychosis" revised by Miklowitz et al. in 2018. FFT will be completed in nine sessions. The first module of the program consists of three sessions, which consists of group psychoeducation for the patients and families. The second and third modules also include three sessions in each to teach communication skills and problem-solving skills in individual therapy sessions including patients and their families. Sessions will be held once a week and completed in nine weeks.
Within the scope of this program, non-therapist clinicians will evaluate the participants' symptoms, psychosocial functioning, insight, and treatment compliance before and after the therapy sessions.
There are only a few previous studies investigating the effects of family therapy in early stages of bipolar disorder and psychotic disorder. According to the literature, no prior study compares the effects of FFT between BD and PD populations. This study is important in terms of developing effective strategies for management of psychosocial difficulties in early phases of BD and PDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Not be in an active phase of the illness
- •Able to comply with the interviews
- •The total score of the Hamilton Depression Rating Scale ≤ 21 points.
- •The total score of the Young Mania Rating Scale ≤ 14 points.
- •At least one family member with the capacity to read and write in Turkish
排除标准
- •Neurological disorders and serious physical disease that affect cognitive functions
- •The symptoms due to substance use or a medical illness
- •Autism Spectrum Disorder
- •Comorbid alcohol and substance abuse (except nicotine)
- •Co-morbid psychiatric disorders except disruptive behavior disorders and anxiety disorders
结局指标
主要结局
The change from Personal and Social Performance Scale (PSP) scores
时间窗: at baseline and at week 9
by independent clinician/ to the patient - The scale evaluates personal and social performance in 4 sub-dimensions; Socially useful activities, personal and social relationships, self-care, irritating and aggressive behavior. 6-point Likert-type rating (1=absent - 6=very severe) was used.
The change from baseline in Scale for the Assessment of Positive Symptoms (SAPS)
时间窗: at baseline and at week 9
by independent clinician/ to the patient - This scale aims to measure severity of positive symptoms in schizophrenia. It includes a total of 34 items in 4 subscales: hallucinations, delusions, bizarre behavior and positive formal thought disorder. Measurements will be made at the beginning and the difference will be examined by repeating at the end of the sessions.
The change from baseline in Brief Negative Symptom Scale (BNSS)
时间窗: at baseline and at week 9
by independent clinician/ to the patient - BNSS consists of 13 items and has six subscales: anhedonia, stress, asociality, avolition, blunt affectivity, and alogia. The total score of the scale, which can range from 0 to 78, is obtained by summing the scores of 13 items. Measurements will be made at the beginning and the difference will be examined by repeating at the end of the sessions.
The change from baseline to follow-up in Hamilton Depression Rating Scale (HDRS) scores
时间窗: at baseline and at week 9
by independent clinician/ to the patient - HDRS is a clinician-administered scale that measures the severity of depression. It contains 17 questions scored between 0-4. The total score of the scale ranges from 0 to 51. Cut-off points were determined as \<7 normal, 8-13 mild, 14-18 moderate, 19-22 severe and \>23 very severe.
The change from baseline in Young Mania Rating Scale score
时间窗: at baseline and at week 9
by independent clinician/ to the patient - The Young Mania Rating Scale (YMRS) is a likert-type scale developed to measure the severity of manic symptoms. 7 of 11 items are graded in the range of 0-4, and the other 4 items are graded in the range of 0-8 points. Therapy sessions will be started if the Young Mania Rating Scale total score is ≤ 14 points. In addition, measurements will be repeated at the end of therapy.
The change from Scale of Unawareness of Mental Disorder (SUMD) scores
时间窗: at baseline and at week 9
by independent clinician/ to the patient - SUMD was developed by Amador et al in 1993 to evaluate insight in psychiatric disorders. The Turkish reliability of this scale was determined by Bora E et al. (Bora et al. 2006). The scale is scored between 1-5 points and consists of 3 general items: being aware of mental disorders, being aware of the effects of drugs, and being aware of the social consequences of the disorder. High scores represent poor insight.
次要结局
- World Health Organization Quality of Life Assessment (WHOQOL)(at baseline and at week 9)
- Coping Strategies Scale Brief Form (Brief COPE)(at baseline and at week 9)
- Shortened Level of Expressed Emotion Scale(at baseline and at week 9)
- Zarit Burden Interview(at baseline and at week 9)
- Beck's Depression Inventory(at baseline and at week 9)
- Mc Master Family Assessment Device(at baseline and at week 9)
研究者
Tevhide Ekin Sut
M.D., Department of Child and Adolescent Psychiatry
Dokuz Eylul University