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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03368027
Other study ID # Retinitis pigmentosa RCT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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