PsoriasisNCT02944630
Psychotherapy for Patients With Psoriasis: Effects in Quality of Life
A study testing Psychotherapy in people with Psoriasis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The aim of this study is to determine the benefits of individual psychotherapy on quality of life for people with psoriasis receiving medical treatment versus a control group (awaiting group) treated with medical treatment, without psychotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2016to Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women at least 18 years old at the time of selection.
- Subjects diagnosed with moderated or severe psoriasis.
- Subjects with a ≥ 10 punctuation in DLQI questionnaire.
- Subjects that are in dermatological treatment.
- Patients should be able to understand and communicate with the investigator.
Who cannot join
- Subjects suffering from a serious concomitant illness.
- Subjects with a mental illness.
- Subjects who are performing psychiatric treatment.
- Subjects who are performing psychotherapy sessions both individual and group.
- Patients who have alcohol dependence or drug abuse.
- Subjects that present legal incapacity or limited legal capacity.
- Subjects presenting illiteracy or language barriers.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Esther Margarit
Barcelona, Barcelona, 08025
Esther Margarit, MSC, +34935537007, emargarit@santpau.cat
Eva Vilarrasa, Dr, +34935537007, evilarrasa@santpau.cat
About this study
The aim of this study is to determine the benefits of individual psychotherapy on quality of life for people with psoriasis receiving medical treatment versus a control group (awaiting group) treated with medical treatment, without psychotherapy.
Read the detailed description
Further investigations studies are needed to determine the efficacy of psychological interventions for people with psoriasis. The aim of this study is to determine the benefits of individual psychotherapy on quality of life for people with psoriasis receiving medical treatment versus a control group (awaiting group) treated with medical treatment, without psychotherapy.
This is an experimental randomized trial with control group. Quality of life, symptoms:
pruritus, scaling and pain, distress and the illness will be measured before and after the intervention using psychological and quality of life questionnaires, and dermatological evaluations for 120 subjects.
The investigators expect that the experimental group scores at the end of the psychotherapy program will be less than 4 points in Visual Analog Scale (VAS) for pruritus, scaling and pain. The Dermatology Quality of Life Index (DQLI) expected to be less than 4 points from the initial score, and the patients are expected to present less than 7 points in Hospital Anxiety and Depression Scale (HADS). The experimental group scores will be less than the control group for quality of life, symptoms and distress.
- Conditions
- Psoriasis
- Being tested
- Psychotherapy
- Keywords
- quality of life, psychotherapy, psoriasis, treatments
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Individual psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental: | Experimental | Receiving psychotherapy and medical treatment. Receives: Behavioral: Psychotherapy |
| Control | No intervention | Awaiting group: Receiving medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatology Quality of Life Index (DLQI)
The Dermatology Life Quality Index or DLQI, developed in 1994, was the first dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions in over 80 countries and is available in over 90 languages. Its use has been described in over 1000 publications including many multinational studies. The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.
Measured: 1 year
Secondary outcomes (7)
Visual analog scale (VAS) for pruritus
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Operationally a VAS is usually a horizontal line, 100 mm in length. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
Measured: 1 year
Visual analog scale (VAS) for pain
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Operationally a VAS is usually a horizontal line, 100 mm in length. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
Measured: 1 year
Visual analog scale (VAS) for scaling
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Operationally a VAS is usually a horizontal line, 100 mm in length. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
Measured: 1 year
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression.
Measured: 1 year
Psoriasis Area Severity Index (PASI)
The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area.
Measured: 1 year
Static Physician's Global Assessment (sPGA)
The PGA is a 5 point ordinal rating ranging from "clear" to "very severe psoriasis".
Measured: 1 year
Body surface area (BSA)
The Body surface area is defined as 9% coverage for the head and neck, each arm, anterior and posterior leg as well as the four trunk quadrants respectively, leaving 1% for the genitalia. The BSA can also be estimated by the number of patients' hand areas affected, assuming that one "handprint" reflects approximately 1% of BSA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona
- Responsible party
- Sponsor
- Investigators
- Esther Margarit de Miguel, Msc, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauAntoni Font Guiteras, PhD, Study director, Universitat Autonoma de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944630
- Sponsor's protocol ID
- IIBSP-PSO-2016-72
- Status last verified
- Oct 2016
- First submitted
- 24 Oct 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapy for Patients With Psoriasis: Effects in Quality of Life
- ClinicalTrials.gov ID
- NCT02944630
- Acronym / sponsor ID
- IIBSP-PSO-2016-72
- Conditions
- Psoriasis
- Keywords
- quality of life, psychotherapy, psoriasis, treatments
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona
- Study start
- Oct 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- 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 determine the benefits of individual psychotherapy on quality of life for people with psoriasis receiving medical treatment versus a control group (awaiting group) treated with medical treatment, without psychotherapy.
Detailed description
Further investigations studies are needed to determine the efficacy of psychological interventions for people with psoriasis. The aim of this study is to determine the benefits of individual psychotherapy on quality of life for people with psoriasis receiving medical treatment versus a control group (awaiting group) treated with medical treatment, without psychotherapy.
This is an experimental randomized trial with control group. Quality of life, symptoms:
pruritus, scaling and pain, distress and the illness will be measured before and after the intervention using psychological and quality of life questionnaires, and dermatological evaluations for 120 subjects.
The investigators expect that the experimental group scores at the end of the psychotherapy program will be less than 4 points in Visual Analog Scale (VAS) for pruritus, scaling and pain. The Dermatology Quality of Life Index (DQLI) expected to be less than 4 points from the initial score, and the patients are expected to present less than 7 points in Hospital Anxiety and Depression Scale (HADS). The experimental group scores will be less than the control group for quality of life, symptoms and distress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: | Experimental | Behavioral: PsychotherapyReceiving psychotherapy and medical treatment. |
| Control | No intervention | –Awaiting group: Receiving medical treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women at least 18 years old at the time of selection.
- Subjects diagnosed with moderated or severe psoriasis.
- Subjects with a ≥ 10 punctuation in DLQI questionnaire.
- Subjects that are in dermatological treatment.
- Patients should be able to understand and communicate with the investigator.
Key exclusion criteria (7 listed)
- Subjects suffering from a serious concomitant illness.
- Subjects with a mental illness.
- Subjects who are performing psychiatric treatment.
- Subjects who are performing psychotherapy sessions both individual and group.
- Patients who have alcohol dependence or drug abuse.
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 |
|---|---|---|
| PsychotherapyIndividual psychotherapy | Behavioural | Experimental: |
Primary outcome
Dermatology Quality of Life Index (DLQI)
Time frame: 1 year
The Dermatology Life Quality Index or DLQI, developed in 1994, was the first dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions in over 80 countries and is available in over 90 languages. Its use has been described in over 1000 publications including many multinational studies. The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.
7 secondary outcomes
Visual analog scale (VAS) for pruritus
Time frame: 1 year
Visual analog scale (VAS) for pain
Time frame: 1 year
Visual analog scale (VAS) for scaling
Time frame: 1 year
Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 year
Psoriasis Area Severity Index (PASI)
Time frame: 1 year
Static Physician's Global Assessment (sPGA)
Time frame: 1 year
Body surface area (BSA)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- 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.
Esther Margarit de Miguel, Msc principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Antoni Font Guiteras, PhD study director
Universitat Autonoma de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Psoriasis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Oct 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esther Margarit de Miguel, Msc (+34696617013, emargarit@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatology Quality of Life Index (DLQI) (time frame: 1 year). 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 26 Oct 2016.