Effects of Guided Written Disclosure Protocol on Psychological Distress and Positive Functioning in Persons With Skin Diseases: a Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change from Pre-test to Post-test and Follow-up in Spiritual Well-Being, which will be reported in the outcome measure results data table as means and standard deviations.
研究概览
简要总结
We conducted a randomized-controlled trial of Guided Written Disclosure Protocol for dermatological patients with the aim of reducing psychological distress, expressive suppression, and skin-related symptoms, and improving spiritual well-being, cognitive reappraisal, and sense of coherence.
详细描述
Sample size assessment: A recent meta-analysis reported a study which showed that Guided Written Disclosure Protocol reach on effect size of 0.89 on psychosocial outcomes (Gidron et al., 2002; Mogk et al., 2006). Power analysis showed that with an alpha of 0.05 and a power of 0.80, we needed a sample of 34 participants to detect effect sizes of 0.89 and higher.
Plan for missing data: Occasional missing values were imputed by calculating, for each participant, the average score for each subscale and then replaced.
Statistical analysis plan: We conducted a 2 (group) X 2 (time [pre-treatment vs. post-treatment]) repeated measures multivariate analysis of variance (MANOVA) for a set of variables.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years;
- •Diagnosis of psoriasis or systemic sclerosis by a board-certified dermatologist.
排除标准
- •Patients with certified mental disorders (e.g., psychotic illness, major depressive disorder)
- •Patients undergoing psychotherapy for at least 6 months in the last 3 years;
- •Patients who currently receive psychopharmacological treatment.
结局指标
主要结局
Change from Pre-test to Post-test and Follow-up in Spiritual Well-Being, which will be reported in the outcome measure results data table as means and standard deviations.
时间窗: Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)
Spiritual well-being will be measured with the FACIT-Sp (minimum value=0; maximum value=48, with higher scores indicating a better outcome), a questionnaire assessing faith, peace and meaning
Change from Pre-test to Post-test and Follow-up in Psychological Distress, which will be reported in the outcome measure results data table as means and standard deviations.
时间窗: Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment)
Psychological distress will be measured with the GHQ-12 (minimum value=1; maximum value=4, with higher score indicating greater outcome).
次要结局
- Change from Pre-test to Post-test and Follow-up in Emotion Regulation, which will be reported in the outcome measure results data table as means and standard deviations.(Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment))
- Change from Pre-test to Post-test and Follow-up in Skin-related Quality of Life, which will be reported in the outcome measure results data table as means and standard deviations.(Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment))
- Change from Pre-test to Post-test and Follow-up in Sense of Coherence, which will be reported in the outcome measure results data table as means and standard deviations.(Pre-Test (before the intervention), Post-Test (30 days after the baseline assessment))
研究者
Luca Iani
Associate Professor
European University of Rome