Clinical trial NCT03368027: Effectiveness of a Cognitive-behavioral Program of Coping With Psychological Stress in People With Retinitis Pigmentosa
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vision Disorders
Stress, Psychological
Psychopathy
Self Efficacy
Keywords: Vision Disorders; Stress, Psychological
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline in vulnerability to stress at 12 weeks
timeFrame: Twelve weeks
Secondary outcomes:
measure: Change from Baseline in Perceived stress scale at 12 weeks
timeFrame: Twelve weeks
measure: Change from Baseline in Symptom Checklist-90-Revised Questionnaire at 12 weeks
timeFrame: Twelve weeks
measure: Change from Baseline in General Self efficacy scale at 12 weeks
timeFrame: Twelve weeks
measure: Change from Baseline in Connor-Davidson Resilience Scale at 12 weeks
timeFrame: Twelve weeks
measure: Change from Baseline in Social support questionnaire at 12 weeks
timeFrame: Twelve weeks
measure: Change from Baseline in Visual Field Test at 12 weeks
timeFrame: Twelve weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: José Manuel Pérez Mármol
Study officials:
affiliation: Department of Physiotherapy. Faculty of Health Sciences, University of Granada
name: José Manuel Pérez Mármol, PhD
role: PRINCIPAL_INVESTIGATOR
References: