Effects of the Guided Disclosure Protocol on Post-Traumatic Growth: A Randomized Control Trial Designed to Observe Psychophysiological Alterations in Traumatic Stress Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Post-Traumatic Growth (PTG)
研究概览
简要总结
This Multicenter study is planned to investigate the effectiveness of the guided disclosure protocol for the promotion of post-traumatic growth (PTG), in the traumatic stress subjects and to determine whether PTG is associated with psychophysiological alterations i.e. (C-Reactive Protein, Brain Derived Neurotropic Factor, Interlukin-6, Cortisol, Heart Rate Variability and brain waves). Study subjects meeting eligibility criteria will be randomized into two groups. Guided disclosure protocol (GDP) will be used as intervention vs the control. Blinded treatment will be provided and the subjects will be made to complete study questionnaires (Screening, Traumatic Stress Scale SSS, Trauma Symptom Checklist, Post-traumatic growth Inventory) at baseline and at post-intervention (3-months later).
详细描述
Study design:
The study will be conducted as multicenter randomized controlled trial. On the basis of eligibility criteria subjects providing consent to participate in the study will be randomized into two groups, experimental group including those who receive the intervention and a control group receiving control intervention. The study outcomes will be monitored in subjects of both groups at different intervals i.e. at baseline and at 3-month follow-up (post-interventional).
Participants Subjects for the present study will be recruited from 5 centers (based in Karachi, Pakistan). The targeted population includes subjects from diverse ethnicity and considered eligible for participation in the study if they indicated in a pre-screening form that they had experienced traumatic event. These subjects will be invited to participate in the study through advertisement on notice board of each center. A written informed consent will be obtained from each study subject after providing detailed information regarding objectives of the study and its duration.
Interventions
The experimental intervention (GDP):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be disease free, there must be no evidence of any metastatic disease
- •Property of written and spoken the English language.
- •Experienced any traumatic event in the last 12 Months
排除标准
- •Subjects who received a structured psychological intervention for at least 6 months during the last 3 years performed by a psychologist or psychiatrist will be excluded.
- •Those with a codified psychiatric disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) who received Psychopharmacological treatment during the last 3 years will also be excluded from the study sample.
研究组 & 干预措施
The experimental intervention (GDP): It includes three writing
-
Participants will be required to describe memories associated with traumatic event in a sequential order, with an objective and detached attitude
-
They will be asked to describe
-
Their opinion regarding the traumatic event and emotions perceived during the experience
-
Its impact on their daily lives, and how it has altered their attitudes toward life.
-
The actual situation will be focused, while reviving the whole traumatic event experience which aids in exploring the following aspects:
- Present thoughts and feelings regarding the traumatic experience, and also clarify the differences between the ones felt at the time of traumatic event in comparison to the current feelings.
- How much they understand and appreciate themselves for successfully dealing with the traumatic event
- To what extent the traumatic event has modified their vision, attitude, knowledge, and skills, and how it can help in their future;
- What will be their future reactions to other similar events.
干预措施: GDP (Behavioral)
The control intervention:
A day prior to each writing session, the researcher will communicate with each study subject via telephone in order to give them a reminder to perform the writing task and to check their understanding regarding the instructions given in the booklet. Details regarding the inability to contact the subject will also be recorded in the patient form.
结局指标
主要结局
Post-Traumatic Growth (PTG)
时间窗: 3 Months
Change in the Post-traumatic Growth Inventory (PTGI) will be observed among the subjects enrolled in the GDP group as compared to the control group.
次要结局
- C- Reactive Protein (CRP)(3 Months)
- Brain-derived neurotrophic factor (BDNF)(3 Months)
- Interleukin-6 (IL-6)(3 Months)
- Glutamate(3 Months)
- Cortisol(3 Months)
- Alpha waves(3 Months)
- Beta waves(3 Months)
- Heart Rate Variability(3 Months)
研究者
Shamoon Noushad
Principal Investigator
University of Karachi