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

Hidradenitis Clinical Trial

Official title:

Group Psychotherapy for Patients With Hidradenitis Suppurativa: Effects in Quality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02904408
• Other study ID #: IIBSP-HID-2016-19
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2016
• Last updated: September 21, 2016
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: September 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Esther Margarit de Miguel, Msc
• Phone: +34696617013
• Email: emargarit[@]santpau.cat
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Behavioral:
• psychotherapy
Group psychotherapy

Locations

Country	Name	City	State
Spain	Esther Margarit	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Universitat Autonoma de Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No
Secondary	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.	1 year	No
Secondary	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.	1 year	No
Secondary	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.	1 year	No
Secondary	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.	1 year	No
Secondary	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.	1 year	No
Secondary	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.	1 year	No