NCT02904408

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

September 1, 2016

Last Update Submit

September 21, 2016

Conditions

Hidradenitis

Keywords

quality of lifepsychotherapyhidradenitistreatments

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Visual analog scale (VAS) for pruritus

    1 year

  • Hospital Anxiety and Depression Scale (HADS)

    1 year

  • Hurley's staging system

    1 year

  • Hidradenitis Supurativa - Physician Global Assessment (HS-PGA)

    1 year

  • Visual analog scale (VAS) for pain

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

experimental group (receiving psychotherapy and medical/surgical treatment)

Behavioral: psychotherapy

Control

NO INTERVENTION

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

Interventions

psychotherapyBEHAVIORAL

Group psychotherapy

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esther Margarit

Barcelona, Barcelona, 08025, Spain

RECRUITING

MeSH Terms

Conditions

Hidradenitis

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Sweat Gland DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Esther Margarit de Miguel, Msc

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

    PRINCIPAL INVESTIGATOR

  • Antoni Font Guiteras, PhD

    Universitat Autonoma de Barcelona

    STUDY DIRECTOR

Central Study Contacts

Esther Margarit de Miguel, Msc

CONTACT

+34696617013emargarit@santpau.cat

Eva Vilarrasa, Dr

CONTACT

+34935537007evilarrasa@santpau.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 19, 2016

Study Start

June 1, 2016

Primary Completion

April 1, 2017

Study Completion

June 1, 2018

Last Updated

September 22, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)