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Clinical Trials/NCT03368027
NCT03368027
Completed
Not Applicable

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

Universidad de Granada1 site in 1 country30 target enrollmentJune 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vision Disorders
Sponsor
Universidad de Granada
Enrollment
30
Locations
1
Primary Endpoint
Change from Baseline in vulnerability to stress at 12 weeks
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2017
End Date
December 3, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

José Manuel Pérez Mármol

Principal Investigator

Universidad de Granada

Eligibility Criteria

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)

Study Sites (1)

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