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

Not Applicable

Completed

• Conditions: Vision Disorders; Self Efficacy; Stress, Psychological; Psychopathy
• Interventions: Behavioral: A cognitive-behavioral intervention program; Other: Standard intervention

• Registration Number: NCT03368027
• Lead Sponsor: Universidad de Granada

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 Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-11
• Primary Completion: 2018-12-03
• Study Completion: 2018-12-03
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress management program	A cognitive-behavioral intervention 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.
Standard intervention	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in vulnerability to stress at 12 weeks	Twelve weeks	This scale registeres the aspects that influence the ability to deal with stress

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Symptom Checklist-90-Revised Questionnaire at 12 weeks	Twelve 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.
Change from Baseline in Perceived stress scale at 12 weeks	Twelve weeks	This scale evaluates the degree to which situations in one's life are appraised as stressful
Change from Baseline in Connor-Davidson Resilience Scale at 12 weeks	Twelve weeks	This scale evaluates stress coping ability.
Change from Baseline in General Self efficacy scale at 12 weeks	Twelve weeks	This scale assesses people's stable believe about their ability to appropriately manage a wide kind of life stressors
Change from Baseline in Social support questionnaire at 12 weeks	Twelve weeks	This instrument evaluates perceived Social support.
Change from Baseline in Visual Field Test at 12 weeks	Twelve weeks	This method evaluates the visual field of two eyes

Trial Locations

Locations (1)

José Manuel Pérez Mármol; 🇪🇸 Granada, Spain