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

NCT03368027 | Completed DMC

• 1 other identifier: Retinitis pigmentosa RCT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Vision Disorders; Stress, Psychological; Psychopathy; Self Efficacy

Keywords

Vision Disorders; Stress, Psychological

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change from Baseline in Perceived stress scale at 12 weeks

  Twelve weeks

• Change from Baseline in Symptom Checklist-90-Revised Questionnaire at 12 weeks

  Twelve weeks

• Change from Baseline in General Self efficacy scale at 12 weeks

  Twelve weeks

• Change from Baseline in Connor-Davidson Resilience Scale at 12 weeks

  Twelve weeks

• Change from Baseline in Social support questionnaire at 12 weeks

  Twelve weeks

Study Arms (2)

Stress management program

EXPERIMENTAL

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

Standard intervention

ACTIVE COMPARATOR

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

Interventions

A cognitive-behavioral intervention program BEHAVIORAL

In this program, participants receive a training of assertive skills, social skills, acceptance, among other psychological aspects.

Also known as: Cognitive-behavioral program

Stress management program

Standard intervention OTHER

Participants receive different activities conducted by a psychologist in the association where the attend.

Also known as: Control group

Standard intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

José Manuel Pérez Mármol

Granada, 18016, Spain

Location

MeSH Terms

Conditions

Vision Disorders; Stress, Psychological; Antisocial Personality Disorder

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• José Manuel Pérez Mármol, PhD

  Department of Physiotherapy. Faculty of Health Sciences, University of Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 11, 2017
• Study Start: June 1, 2017
• Primary Completion: December 3, 2018
• Study Completion: December 3, 2018
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)