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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Granada
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Change from Baseline in vulnerability to stress at 12 weeks
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change from Baseline in vulnerability to stress at 12 weeks
Time Frame: Twelve weeks
This scale registeres the aspects that influence the ability to deal with stress
Secondary Outcomes
- 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)
Investigators
José Manuel Pérez Mármol
Principal Investigator
Universidad de Granada