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Psychotherapy for Patients With Psoriasis: Effects in Quality of Life

  Purpose

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.

Condition Intervention
Psoriasis Behavioral: Psychotherapy

Study Type: Interventional
Study Design:Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title:Psychotherapy for Patients With Psoriasis: Effects in Quality of Life

Resource links provided by NLM:

Further study details as provided by Fundació Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:

  • 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.

Secondary Outcome Measures:

  • Visual analog scale (VAS) for pruritus [ Time Frame: 1 year ]
    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.

  • Visual analog scale (VAS) for pain [ Time Frame: 1 year ]
    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.

  • Visual analog scale (VAS) for scaling [ Time Frame: 1 year ]
    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.

  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 1 year ]
    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.

  • Psoriasis Area Severity Index (PASI) [ Time Frame: 1 year ]
    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.

  • Static Physician’s Global Assessment (sPGA) [ Time Frame: 1 year ]
    The PGA is a 5 point ordinal rating ranging from “clear” to “very severe psoriasis”.

  • Body surface area (BSA) [ Time Frame: 1 year ]
    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

Estimated Enrollment:120
Study Start Date:October 2016
Estimated Study Completion Date:January 2020
Estimated Primary Completion Date:January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental:

Receiving psychotherapy and medical treatment.
Behavioral: Psychotherapy

Individual psychotherapy
No Intervention: Control

Awaiting group: Receiving medical treatment.

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.

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