Clinical trial NCT02944630: Psychotherapy for Patients With Psoriasis: Effects in Quality of Life
Official title: Psychotherapy for Patients With Psoriasis: Effects in Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis
Keywords: quality of life
psychotherapy
psoriasis
treatments
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Universitat Autonoma de Barcelona
First posted: 2016-10-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dermatology Quality of Life Index (DLQI)
timeFrame: 1 year
Secondary outcomes:
measure: Visual analog scale (VAS) for pruritus
timeFrame: 1 year
measure: Visual analog scale (VAS) for pain
timeFrame: 1 year
measure: Visual analog scale (VAS) for scaling
timeFrame: 1 year
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 year
measure: Psoriasis Area Severity Index (PASI)
timeFrame: 1 year
measure: Static Physician's Global Assessment (sPGA)
timeFrame: 1 year
measure: Body surface area (BSA)
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Esther Margarit
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Esther Margarit de Miguel, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Autonoma de Barcelona
name: Antoni Font Guiteras, PhD
role: STUDY_DIRECTOR
References: