ClinicalTrials.gg
CompletedNCT03368027RCTUpdated Feb 17, 2020

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

An interventional study of A cognitive-behavioral intervention program and Standard intervention in Vision Disorders, Stress, Psychological and Psychopathy, sponsored by Universidad de Granada. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jun 2017, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

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

Keywords

  • Vision Disorders; Stress, Psychological
03

In context

Vision Disorders

360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.

This study's enrollment of 30 is below the median of 78 across 244 interventional studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

Universidad de Granada is the lead sponsor of 246 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • no visual remainders (advanced retinosis).
  • no studies.
  • cognitive impairment, determined by the Spanish - MMSE test.
  • mobility problems
  • high risk of falls associated with retinosis, measured by the Morse scale, with a score over 50 points.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: A cognitive-behavioral intervention program

  • Active comparator
    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.

    Other: Standard intervention

Interventions

  • BehavioralA cognitive-behavioral intervention program

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

    Also known as: Cognitive-behavioral program

  • OtherStandard intervention

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

    Also known as: Control group

06

What researchers measure

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

    Time frame: Twelve weeks

Secondary outcomes

  1. 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

    Time frame: Twelve weeks

  2. 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.

    Time frame: Twelve weeks

  3. 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

    Time frame: Twelve weeks

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

    This scale evaluates stress coping ability.

    Time frame: Twelve weeks

  5. Change from Baseline in Social support questionnaire at 12 weeks

    This instrument evaluates perceived Social support.

    Time frame: Twelve weeks

  6. Change from Baseline in Visual Field Test at 12 weeks

    This method evaluates the visual field of two eyes

    Time frame: Twelve weeks

07

Study locations

1 site
  • José Manuel Pérez Mármol
    Granada, 18016, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03368027
Responsible party
José Manuel Pérez Mármol (Principal Investigator, Universidad de Granada) — Principal investigator
First posted
Dec 11, 2017
Start date
Jun 1, 2017
Primary completion
Dec 3, 2018
Completion
Dec 3, 2018
Last update
Feb 17, 2020

Study contacts

José Manuel Pérez Mármol, PhD
principal investigator · Department of Physiotherapy. Faculty of Health Sciences, University of Granada

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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