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

Stress, Psychological Clinical Trial

— RCT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03368027
• Other study ID #: Retinitis pigmentosa RCT
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 3, 2018

Study information

• Verified date: February 2020
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 3, 2018
• Est. primary completion date: December 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychopathy
• Retinitis
• Retinitis Pigmentosa
• Self Efficacy
• Stress, Psychological
• Vision Disorders

Intervention

Behavioral:
• A cognitive-behavioral intervention program
In this program, participants receive a training of assertive skills, social skills, acceptance, among other psychological aspects.

Other:
• Standard intervention
Participants receive different activities conducted by a psychologist in the association where the attend.

Locations

Country	Name	City	State
Spain	José Manuel Pérez Mármol	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change from Baseline in Connor-Davidson Resilience Scale at 12 weeks	This scale evaluates stress coping ability.	Twelve weeks
Secondary	Change from Baseline in Social support questionnaire at 12 weeks	This instrument evaluates perceived Social support.	Twelve weeks
Secondary	Change from Baseline in Visual Field Test at 12 weeks	This method evaluates the visual field of two eyes	Twelve weeks