Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Pain-Visual Analog Scale
研究概览
简要总结
The hypothesis of the study is that group therapy in fibromyalgia patients can provide significant improvement in pain, fatigue, anxiety and depression levels and emotional expressions.
详细描述
The purpose of our study; to determine the effectiveness of group psychotherapy in the treatment of Fibromyalgia Syndrome.
Patients who received 9 weeks of group therapy and those who did not, at the beginning of treatment, at the end of 9 weeks and 6 months after treatment will be evaluated using The Short Form-36, Fibromyalgia Impact Questionnaire, Revised Fibromyalgia Impact Questionnaire, Hospital Anxiety and Depression Scale, Fatigue Severity Scale, Beck Depression Inventory, Beck Anxiety Inventory, Pain Beliefs Scale, Emotional Expression Questionnaire, Visual Analogue Scale, Childhood Trauma Questionnaire, 2016 Fibromyalgia Diagnostic Criteria.
At the end of the study, individuals are expected to show less depressive symptoms and anxiety symptoms compared to the beginning of the study, and it is thought that their complaints about pain will decrease.
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)
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
- •Fibromyalgia Syndrome diagnosed according to 2016 Fibromyalgia Syndrome diagnostic criteria
- •Volunteers between the ages of 18-65
- •Literate volunteers
- •Volunteering to participate in group work
- •There is no obstacle to attend the sessions regularly every week
排除标准
- •Who cannot participate in 9-week group therapy
- •Under 18, over 65 years old
- •Confused enough to not be able to complete and understand the scales given cognitively
- •Having serious mental illness (eg Psychotic disorder, Mental Retardation etc.)
- •Illiterate individuals
研究组 & 干预措施
control group
Patients in this group will receive recommendations regarding lifestyle change, exercise, and nutrition related to fibromyalgia.
intervention group
Patients in this group will receive recommendations regarding lifestyle change, exercise, and nutrition related to fibromyalgia and group psychotherapy.
干预措施: Group Psychotherapy (Other)
结局指标
主要结局
Change in Pain-Visual Analog Scale
时间窗: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Chronic musculoskeletal pain in Fibromyalgia syndrome patients, in this scale minumum value is 0, maximum value is 10, higher scores means worse outcome.
Change in Depression-Beck Depression Inventory
时间窗: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Depression in Fibromyalgia patients
Change in Anxiety-Beck Anxiety Inventory
时间窗: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Anxiety in Fibromyalgia patients
次要结局
- Change in 2016 Fibromyalgia Syndrome Criteria(At the beginnning of the study ,through study completion-8th week, after study completion -6th month)
- Change in Revised Fibromyalgia Impact Questionnaire(At the beginnning of the study ,through study completion-8th week, after study completion -6th month)
- Change in Emotional Expression Questionnaire(At the beginnning of the study ,through study completion-8th week, after study completion -6th month)
- Change in The Short Form (36) Health Survey(At the beginnning of the study ,through study completion-8th week, after study completion -6th month)
- Change in The Fatigue Severity Scale(At the beginnning of the study ,through study completion-8th week, after study completion -6th month)
- CHILDHOOD TRAUMA QUESTIONNAIRE(At the beginning of the study)
- Change in Fibromyalgia Impact Questionaire(At the beginnning of the study ,through study completion-8th week, after study completion -6th month)
- Change in Hospital Anxiety and Depression Scale(At the beginnning of the study ,through study completion-8th week, after study completion -6th month)
- Change in Pain beliefs questionnaire(At the beginnning of the study ,through study completion-8th week, after study completion -6th month)
研究者
Meryem Burcu Turkoglu
Principal invastigator
Ege University