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Completed

NCT Number: NCT03368027

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

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).

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Key information

Conditions

Vision Disorders Antisocial Personality Disorder Behavior Behavioral Symptoms Eye Diseases Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Personality Disorders Psychopathy Self Efficacy Sensation Disorders Signs and Symptoms Stress, Psychological

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

José Manuel Pérez Mármol

Granada, 18016, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A cognitive-behavioral intervention program

Behavioral

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

Other names: Cognitive-behavioral program

Standard intervention

Other

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

Other names: Control group

Primary outcomes

  1. Change from Baseline in vulnerability to stress at 12 weeks

    Time frame: Twelve weeks

    This scale registeres the aspects that influence the ability to deal with stress

Secondary outcomes

  1. Change from Baseline in Perceived stress scale at 12 weeks

    Time frame: Twelve weeks

    This scale evaluates the degree to which situations in one's life are appraised as stressful

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

    Time frame: Twelve 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.

  3. Change from Baseline in General Self efficacy scale at 12 weeks

    Time frame: Twelve weeks

    This scale assesses people's stable believe about their ability to appropriately manage a wide kind of life stressors

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

    Time frame: Twelve weeks

    This scale evaluates stress coping ability.

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

    Time frame: Twelve weeks

    This instrument evaluates perceived Social support.

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

    Time frame: Twelve weeks

    This method evaluates the visual field of two eyes

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study 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

Acronym: RCT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2017
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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