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

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ClinicalTrials.gov Identifier: NCT02904408
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : September 22, 2016
Sponsor:
Collaborator:
Universitat Autonoma de Barcelona
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Condition or disease Intervention/treatment Phase
Hidradenitis Behavioral: psychotherapy Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Group Psychotherapy for Patients With Hidradenitis Suppurativa: Effects in Quality
Study Start Date : June 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
experimental group (receiving psychotherapy and medical/surgical treatment)
Behavioral: psychotherapy
Group psychotherapy

No Intervention: Control
control group (awaiting group) (receiving medical/surgical treatment)



Primary Outcome Measures :
  1. 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 :
  1. 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.


  2. 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.

  3. 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.

  4. 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.

  5. 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.


  6. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women at least 18 years old at the time of selection.
  • Subjects diagnosed with hidradenitis suppurativa.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904408


Contacts
Contact: Esther Margarit de Miguel, Msc +34696617013 emargarit@santpau.cat
Contact: Eva Vilarrasa, Dr +34935537007 evilarrasa@santpau.cat

Locations
Spain
Esther Margarit Recruiting
Barcelona, Spain, 08025
Contact: Esther Margarit, MSC    +34935537007    emargarit@santpau.cat   
Contact: Eva Vilarrasa, Dr    +34935537007    evilarrasa@santpau.cat   
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Universitat Autonoma de Barcelona
Investigators
Principal Investigator: Esther Margarit de Miguel, Msc Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Director: Antoni Font Guiteras, PhD Universitat Autonoma de Barcelona

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02904408     History of Changes
Other Study ID Numbers: IIBSP-HID-2016-19
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
quality of life
psychotherapy
hidradenitis
treatments

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration