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

NCT ID: NCT03368027

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-12-03

Brief Summary

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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

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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.

Conditions

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Vision Disorders Stress, Psychological Psychopathy Self Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

A cognitive-behavioral intervention program

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Standard intervention

Intervention Type OTHER

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

Interventions

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A cognitive-behavioral intervention program

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

Intervention Type BEHAVIORAL

Standard intervention

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

Intervention Type OTHER

Other Intervention Names

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Cognitive-behavioral program Control group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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José Manuel Pérez Mármol

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José Manuel Pérez Mármol, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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José Manuel Pérez Mármol

Granada, , Spain

Site Status

Countries

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Spain

Other Identifiers

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Retinitis pigmentosa RCT

Identifier Type: -

Identifier Source: org_study_id

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