Psychotherapy for Patients With Psoriasis: Effects in Quality of Life

NCT ID: NCT02944630

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2020-01-31

Brief Summary

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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

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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

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Psoriasis

Keywords

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quality of life psychotherapy psoriasis treatments

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental:

Receiving psychotherapy and medical treatment.

Group Type EXPERIMENTAL

Psychotherapy

Intervention Type BEHAVIORAL

Individual psychotherapy

Control

Awaiting group: Receiving medical treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychotherapy

Individual psychotherapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitat Autonoma de Barcelona

OTHER

Sponsor Role collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esther Margarit de Miguel, Msc

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Antoni Font Guiteras, PhD

Role: STUDY_DIRECTOR

Universitat Autonoma de Barcelona

Locations

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Esther Margarit

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Esther Margarit de Miguel, Msc

Role: CONTACT

Phone: +34696617013

Email: [email protected]

Eva Vilarrasa, Dr

Role: CONTACT

Phone: +34935537007

Email: [email protected]

Facility Contacts

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Esther Margarit, MSC

Role: primary

Eva Vilarrasa, Dr

Role: backup

Other Identifiers

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IIBSP-PSO-2016-72

Identifier Type: -

Identifier Source: org_study_id