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

Primary Purpose

Vision Disorders, Stress, Psychological, Psychopathy

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
A cognitive-behavioral intervention program
Standard intervention
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vision Disorders focused on measuring Vision Disorders; Stress, Psychological

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • José Manuel Pérez Mármol

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stress management program

Standard intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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
Change from Baseline in Connor-Davidson Resilience Scale at 12 weeks
This scale evaluates stress coping ability.
Change from Baseline in Social support questionnaire at 12 weeks
This instrument evaluates perceived Social support.
Change from Baseline in Visual Field Test at 12 weeks
This method evaluates the visual field of two eyes

Full Information

First Posted
December 5, 2017
Last Updated
February 13, 2020
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT03368027
Brief Title
Effectiveness of a Cognitive-behavioral Program of Coping With Psychological Stress in People With Retinitis Pigmentosa
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 3, 2018 (Actual)
Study Completion Date
December 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vision Disorders, Stress, Psychological, Psychopathy, Self Efficacy
Keywords
Vision Disorders; Stress, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stress management program
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
A cognitive-behavioral intervention program
Other Intervention Name(s)
Cognitive-behavioral program
Intervention Description
In this program, participants receive a training of assertive skills, social skills, acceptance, among other psychological aspects.
Intervention Type
Other
Intervention Name(s)
Standard intervention
Other Intervention Name(s)
Control group
Intervention Description
Participants receive different activities conducted by a psychologist in the association where the attend.
Primary Outcome Measure Information:
Title
Change from Baseline in vulnerability to stress at 12 weeks
Description
This scale registeres the aspects that influence the ability to deal with stress
Time Frame
Twelve weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Perceived stress scale at 12 weeks
Description
This scale evaluates the degree to which situations in one's life are appraised as stressful
Time Frame
Twelve weeks
Title
Change from Baseline in Symptom Checklist-90-Revised Questionnaire at 12 weeks
Description
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.
Time Frame
Twelve weeks
Title
Change from Baseline in General Self efficacy scale at 12 weeks
Description
This scale assesses people's stable believe about their ability to appropriately manage a wide kind of life stressors
Time Frame
Twelve weeks
Title
Change from Baseline in Connor-Davidson Resilience Scale at 12 weeks
Description
This scale evaluates stress coping ability.
Time Frame
Twelve weeks
Title
Change from Baseline in Social support questionnaire at 12 weeks
Description
This instrument evaluates perceived Social support.
Time Frame
Twelve weeks
Title
Change from Baseline in Visual Field Test at 12 weeks
Description
This method evaluates the visual field of two eyes
Time Frame
Twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Manuel Pérez Mármol, PhD
Organizational Affiliation
Department of Physiotherapy. Faculty of Health Sciences, University of Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
José Manuel Pérez Mármol
City
Granada
ZIP/Postal Code
18016
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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