Effectiveness of a Cognitive-behavioral Program of Coping With Psychological Stress in People With Retinitis Pigmentosa

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.

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

Conditions
-----------------
Vision Disorders, Stress, Psychological, Psychopathy, Self Efficacy

Intervention / Treatment
-----------------
* Behavioral: A cognitive-behavioral intervention program
* Other: Standard intervention


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress management program<br>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. | Behavioral: A cognitive-behavioral intervention program<br>* In this program, participants receive a training of assertive skills, social skills, acceptance, among other psychological aspects.<br>* Other names: Cognitive-behavioral program;|
| Active Comparator: Standard intervention<br>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. | Other: Standard intervention<br>* Participants receive different activities conducted by a psychologist in the association where the attend.<br>* Other names: Control group;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in vulnerability to stress at 12 weeks | This scale registeres the aspects that influence the ability to deal with stress | Twelve weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Perceived stress scale at 12 weeks | This scale evaluates the degree to which situations in one's life are appraised as stressful | Twelve weeks | 
| Change from Baseline in Symptom Checklist-90-Revised Questionnaire at 12 weeks | This instrument is a 90-item self-report symptom inventory developed by Leonard R. Derogatis in the mid-1970s to measure psychological symptoms and psychological distress. | Twelve weeks | 
| Change from Baseline in General Self efficacy scale at 12 weeks | This scale assesses people's stable believe about their ability to appropriately manage a wide kind of life stressors | Twelve weeks | 
| Change from Baseline in Connor-Davidson Resilience Scale at 12 weeks | This scale evaluates stress coping ability. | Twelve weeks | 
| Change from Baseline in Social support questionnaire at 12 weeks | This instrument evaluates perceived Social support. | Twelve weeks | 
| Change from Baseline in Visual Field Test at 12 weeks | This method evaluates the visual field of two eyes | Twelve weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vision Disorders; Stress, Psychological