NCT02944630

Brief Summary

The aim of this study is to determine the benefits of individual psychotherapy on quality of life for people with psoriasis receiving medical treatment versus a control group (awaiting group) treated with medical 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 Oct 2016

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

2.3 years

First QC Date

October 24, 2016

Last Update Submit

October 24, 2016

Conditions

Psoriasis

Keywords

quality of lifepsychotherapypsoriasistreatments

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 (7)

  • Visual analog scale (VAS) for pruritus

    1 year

  • Visual analog scale (VAS) for pain

    1 year

  • Visual analog scale (VAS) for scaling

    1 year

  • Hospital Anxiety and Depression Scale (HADS)

    1 year

  • Psoriasis Area Severity Index (PASI)

    1 year

  • +2 more secondary outcomes

Study Arms (2)

Experimental:

EXPERIMENTAL

Receiving psychotherapy and medical treatment.

Behavioral: Psychotherapy

Control

NO INTERVENTION

Awaiting group: Receiving medical treatment.

Interventions

PsychotherapyBEHAVIORAL

Individual 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 moderated or severe psoriasis.
  • Subjects with a ≥ 10 punctuation in DLQI questionnaire.
  • 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

Psoriasis

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin 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

October 24, 2016

First Posted

October 26, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

October 26, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)