Vision DisordersRCTNCT03368027
Effectiveness of a Cognitive-behavioral Program of Coping With Psychological Stress in People With Retinitis Pigmentosa
A study testing A cognitive-behavioral intervention program and Standard intervention in people with Vision Disorders and Stress, Psychological, run by Universidad de Granada at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vision Disorders, Stress, Psychological, Psychopathy
- What is being tested?
- A cognitive-behavioral intervention program and Standard intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2017to 3 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Vision Disorders, Stress, Psychological, Psychopathy, Self Efficacy
- Being tested
- A cognitive-behavioral intervention program, Standard intervention
- Keywords
- Vision Disorders; Stress, Psychological
- Medical subject headings
- Vision Disorders, Stress, Psychological, Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A cognitive-behavioral intervention programBehavioural
Also called Cognitive-behavioral program
In this program, participants receive a training of assertive skills, social skills, acceptance, among other psychological aspects.
Standard interventionOther
Also called Control group
Participants receive different activities conducted by a psychologist in the association where the attend.
| Study group | Role | What they receive |
|---|---|---|
| Stress management program | Experimental | 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. Receives: Behavioral: A cognitive-behavioral intervention program |
| Standard intervention | Active comparator | 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. Receives: Other: Standard intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in vulnerability to stress at 12 weeks
This scale registeres the aspects that influence the ability to deal with stress
Measured: Twelve weeks
Secondary outcomes (6)
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
Measured: Twelve weeks
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.
Measured: Twelve weeks
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
Measured: Twelve weeks
Change from Baseline in Connor-Davidson Resilience Scale at 12 weeks
This scale evaluates stress coping ability.
Measured: Twelve weeks
Change from Baseline in Social support questionnaire at 12 weeks
This instrument evaluates perceived Social support.
Measured: Twelve weeks
Change from Baseline in Visual Field Test at 12 weeks
This method evaluates the visual field of two eyes
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start1 Jun 2017
- Primary completion3 Dec 2018
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Manuel Pérez Mármol, Universidad de Granada
- Investigators
- José Manuel Pérez Mármol, PhD, Principal investigator, Department of Physiotherapy. Faculty of Health Sciences, University of Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368027
- Sponsor's protocol ID
- Retinitis pigmentosa RCT
- Acronym
- RCT
- Status last verified
- Feb 2020
- First submitted
- 5 Dec 2017
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03368027
- Acronym / sponsor ID
- RCT / Retinitis pigmentosa RCT
- Conditions
- Vision Disorders, Stress, Psychological, Psychopathy, Self Efficacy
- Keywords
- Vision Disorders; Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress management program | Experimental | Behavioral: A cognitive-behavioral intervention programA 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. |
| Standard intervention | Active comparator | Other: Standard interventionUsual 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A cognitive-behavioral intervention programAlso: Cognitive-behavioral programIn this program, participants receive a training of assertive skills, social skills, acceptance, among other psychological aspects. | Behavioural | Stress management program |
| Standard interventionAlso: Control groupParticipants receive different activities conducted by a psychologist in the association where the attend. | Other | Standard intervention |
Primary outcome
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
6 secondary outcomes
Change from Baseline in Perceived stress scale at 12 weeks
Time frame: Twelve weeks
Change from Baseline in Symptom Checklist-90-Revised Questionnaire at 12 weeks
Time frame: Twelve weeks
Change from Baseline in General Self efficacy scale at 12 weeks
Time frame: Twelve weeks
Change from Baseline in Connor-Davidson Resilience Scale at 12 weeks
Time frame: Twelve weeks
Change from Baseline in Social support questionnaire at 12 weeks
Time frame: Twelve weeks
Change from Baseline in Visual Field Test at 12 weeks
Time frame: Twelve weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Manuel Pérez Mármol, PhD principal investigator
Department of Physiotherapy. Faculty of Health Sciences, University of Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A cognitive-behavioral intervention program and Standard intervention in people with Vision Disorders and Stress, Psychological, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in vulnerability to stress at 12 weeks (time frame: Twelve weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.