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

Primary Purpose

Hidradenitis

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
psychotherapy
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis focused on measuring quality of life, psychotherapy, hidradenitis, treatments

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Esther MargaritRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

experimental group (receiving psychotherapy and medical/surgical treatment)

control group (awaiting group) (receiving medical/surgical treatment)

Outcomes

Primary Outcome Measures

Dermatology Quality of Life Index (DLQI)
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
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)
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
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)
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
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
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.

Full Information

First Posted
September 1, 2016
Last Updated
September 21, 2016
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Universitat Autonoma de Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT02904408
Brief Title
Group Psychotherapy for Patients With Hidradenitis Suppurativa: Effects in Quality of Life
Official Title
Group Psychotherapy for Patients With Hidradenitis Suppurativa: Effects in Quality
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Universitat Autonoma de Barcelona

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis
Keywords
quality of life, psychotherapy, hidradenitis, treatments

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
experimental group (receiving psychotherapy and medical/surgical treatment)
Arm Title
Control
Arm Type
No Intervention
Arm Description
control group (awaiting group) (receiving medical/surgical treatment)
Intervention Type
Behavioral
Intervention Name(s)
psychotherapy
Intervention Description
Group psychotherapy
Primary Outcome Measure Information:
Title
Dermatology Quality of Life Index (DLQI)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS) for pruritus
Description
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.
Time Frame
1 year
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
1 year
Title
Hurley's staging system
Description
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.
Time Frame
1 year
Title
Hidradenitis Supurativa - Physician Global Assessment (HS-PGA)
Description
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.
Time Frame
1 year
Title
Visual analog scale (VAS) for pain
Description
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.
Time Frame
1 year
Title
Visual analog scale (VAS) for odor
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Margarit de Miguel, Msc
Phone
+34696617013
Email
emargarit@santpau.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Vilarrasa, Dr
Phone
+34935537007
Email
evilarrasa@santpau.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Margarit de Miguel, Msc
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoni Font Guiteras, PhD
Organizational Affiliation
Universitat Autonoma de Barcelona
Official's Role
Study Director
Facility Information:
Facility Name
Esther Margarit
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Margarit, MSC
Phone
+34935537007
Email
emargarit@santpau.cat
First Name & Middle Initial & Last Name & Degree
Eva Vilarrasa, Dr
Phone
+34935537007
Email
evilarrasa@santpau.cat

12. IPD Sharing Statement

Plan to Share IPD
No

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

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