Clinical Trial: Group Psychotherapy for Patients With Hidradenitis Suppurativa: Effects in Quality of Life

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Group Psychotherapy for Patients With Hidradenitis Suppurativa: Effects in Quality

Brief Summary: The aim of this study is to determine the benefits of group psychotherapy on quality of life for people with hidradenitis suppurativa receiving medical and surgical treatment versus a control group (awaiting group) treated with medical and surgical treatment, without psychotherapy.

Detailed Summary:

Further investigations studies are needed to determine the efficacy of psychological interventions for people with hidradenitis suppurativa.

The aim of this study is to determine the benefits of group psychotherapy on quality of life for people with hidradenitis suppurativa receiving medical and surgical treatment versus a control group (awaiting group) treated with medical and surgical treatment, without psychotherapy.

This is an experimental randomized trial with control group. Quality of life, symptoms: pruritus, odor 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, odor 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.


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

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.

  • 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.
  • Hurley's staging system [ Time Frame: 1 year ]
    Hurley separated patients into three groups based largely on the presence and extent of cicatrization and sinuses. It has been used as a basis for clinical trials in the past and is a useful basis to approach therapy for patients. These three stages are based on Hurley's staging system, which is simple and relies on the subjective extent of the diseased tissue the patient has. Hurley's three stages of hidradenitis suppurativa.
  • Hidradenitis Supurativa - Physician Global Assessment (HS-PGA) [ Time Frame: 1 year ]
    The six-point Physician Global Assessment (PGA) ranges from clear to very severe. It is used in clinical trials to measure clinical improvement in inflammatory nodules, abscesses and draining fistulae.
  • 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 odor [ 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.



Original Secondary Outcome:

  • Visual analog scale (VAS) for: pruritus, odor and 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.

  • 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.
  • Hurley's staging system [ Time Frame: 1 year ]
    Hurley separated patients into three groups based largely on the presence and extent of cicatrization and sinuses. It has been used as a basis for clinical trials in the past and is a useful basis to approach therapy for patients. These three stages are based on Hurley's staging system, which is simple and relies on the subjective extent of the diseased tissue the patient has. Hurley's three stages of hidradenitis suppurativa.
  • Hidradenitis Supurativa - Physician Global Assessment (HS-PGA) [ Time Frame: 1 year ]
    The six-point Physician Global Assessment (PGA) ranges from clear to very severe. It is used in clinical trials to measure clinical improvement in inflammatory nodules, abscesses and draining fistulae.


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

Dates:
Date Received: September 1, 2016
Date Started: June 2016
Date Completion: June 2018
Last Updated: September 21, 2016
Last Verified: September 2016