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

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

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).

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; Vision Disorders; Self Efficacy; Psychopathy
• Intervention / Treatment: Behavioral: A cognitive-behavioral intervention program; Other: Standard intervention

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18016
    • José Manuel Pérez Mármol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: José Manuel Pérez Mármol, PhD, Department of Physiotherapy. Faculty of Health Sciences, University of Granada

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): December 3, 2018
• Study Completion (Actual): December 3, 2018

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Vision Disorders; Stress, Psychological
• Additional Relevant MeSH Terms: Behavioral Symptoms; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Sensation Disorders; Retinitis; Retinitis Pigmentosa; Stress, Psychological; Vision Disorders
• Other Study ID Numbers: Retinitis pigmentosa RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No