Effectiveness of a Program for Coping With Psychological Stress on Stress, Psychopathology, Self-efficacy, Resilience, Social Support and Visual Field in People With Retinitis Pigmentosa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from Baseline in vulnerability to stress at 12 weeks
研究概览
简要总结
The aim of this study is to evaluate the efficacy of cognitive - behavioral therapy for the control of psychopathological stress and the disease of people with Retinitis Pigmentosa (RP).
详细描述
This randomized controlled trial aims to evaluate the efficacy of cognitive - behavioral therapy for the control of psychopathological stress and the disease of people with Retinitis Pigmentosa (RP) on aspects such as vulnerability to stress, perceived stress, psychopathological state, general self-efficacy, resilience, satisfaction with social support and visual field. This study has two groups: 1) cognitive - behavioral therapy group, and 2) Standard intervention or control group. The two interventions will be conducted for 3 months (with a total of 12 sessions), one session per week, with a duration of 90 minutes per session.
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
- Double (Investigator, 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
- •diagnosed with Retinitis Pigmentosa (legally blind RP patients).
- •meet the membership criteria of the Spanish National Association of ONCE.
- •having a reduction of the visual field of at least 10 degrees in both eyes
- •having an age between 18 and 65 years.
排除标准
- •no visual remainders (advanced retinosis).
- •no studies.
- •cognitive impairment, determined by the Spanish Mini-Mental State Examination - MMSE test.
- •mobility problems
- •high risk of falls associated with retinosis, measured by the Morse scale, with a score over 50 points.
研究组 & 干预措施
Stress management program
A cognitive-behavioral program of coping with psychological stress for 3 months (with a total of 12 sessions), one session per week, with a duration of 90 minutes per session.
干预措施: A cognitive-behavioral intervention program (Behavioral)
Standard intervention
Usual activities performed in the association where they attend (supervised by a psychologist) for 3 months (with a total of 12 sessions), one session per week, with a duration of 90 minutes per session.
干预措施: Standard intervention (Other)
结局指标
主要结局
Change from Baseline in vulnerability to stress at 12 weeks
时间窗: Twelve weeks
This scale registeres the aspects that influence the ability to deal with stress
次要结局
- Change from Baseline in Symptom Checklist-90-Revised Questionnaire at 12 weeks(Twelve weeks)
- Change from Baseline in Perceived stress scale at 12 weeks(Twelve weeks)
- Change from Baseline in Connor-Davidson Resilience Scale at 12 weeks(Twelve weeks)
- Change from Baseline in General Self efficacy scale at 12 weeks(Twelve weeks)
- Change from Baseline in Social support questionnaire at 12 weeks(Twelve weeks)
- Change from Baseline in Visual Field Test at 12 weeks(Twelve weeks)
研究者
José Manuel Pérez Mármol
Principal Investigator
Universidad de Granada