Clinical trial NCT04030819: Effectiveness of a Schema Therapy on Anxiety in Patients With Multiple Sclerosis
Official title: Effectiveness of a Schema Therapy on Anxiety in Patients With Multiple Sclerosis .a Randomized Control Study in 106Persian Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Keywords: anxiety
multiple sclerosis
schema therapy
Lead sponsor: Paris Nanterre University
Sponsor class: OTHER
Collaborators: name: Isfahan University of Medical Sciences
First posted: 2019-07-24
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is a multicentric randomized and controlled study comparing a Scheme therapy program versus local practice in RRMS patients with anxiety. Patients will assist to twenty once-weekly group sessions with a 6-month follow up after the end of the programme. The main criteria is the impact of schema therapy on anxiety evaluated by the questionnaires at the end of the program and at the end of the 6-month follow-up.

Detailed description: A parallel arm randomized controlled trial comparing a group receiving Scheme Therapy plus current usual practice versus a group receiving current local practice only. The trial will take place in KASHANI Hospital (in Isfahan).Recruitment of the participants will be identified and recruited by the neurologists of the hospitals who take part in the programme, when they come for a medical examination.

After giving their informed consent, the patients will be entered onto the trial database and randomized to either the schema therapy or control using software allocated The intervention is the schema therapy focuses on the management of anxiety and is based on self-efficacy, self-management . It consists of 20 once-weekly sessions of 90 minutes (with a 15 Min break), with homework activities between the sessions. It is designed for groups of 8 people and will be delivered by two psychologists. The programme is standardized: Power Points presentations support each session and a detailed therapist manual and companion patient workbook accompany the programme.

For the ST group an evaluation will be administered pretest and post-test six months after the end of the schema therapy programme and at the same times for those in the control group. Socio-demographic and medical data, age, sex, level of education, marital status, number of children and professional status; date of diagnosis, disease type, level of disability (EDSS, Kurtzke, 1983) and information on relapses and treatments, are evaluated. The main criteria is the impact of schema therapy on anxiety evaluated by the BAI (beck anxiety inventory ) and level of cortisol at 6 month after the start program . Secondary criteria are: impact on the psychological dimensions assessed by Hospital Anxiety and Depression Scale (HADS), intensity of fatigue assessed by Fatigue Severity Scale (FSS), sleep quality evaluated by the Pittsburgh Sleep Quality Index(PSQI) depression by BDI (beck depression inventory ) and quality of life evaluated by (Multiple sclerosis impact scale) MSIS29.

Eligibility criteria: Inclusion Criteria:

* subject has relapsing remitting MS
* anxiety (score \>26 at the BAI scale)
* history of psychotic disorders
* history of cognitive deficiency
* use anti-depressant in the past 3 months
* history of relapse in the past 3 month
* expanded Disability Status Scale score less than 6
* ability reading and writing Persian
* Non hospitalized

Exclusion Criteria:

* history of psychotic disorders
* history of cognitive deficiency
* use anti-depressant in the past 3 months
* history of relapse in the past 3 month

Primary outcomes:
measure: changes Anxiety in patient with MS,Beck Anxiety Inventory (BAI)
timeFrame: Change measures in 0,6,12 month
measure: changes in level of cortisol
timeFrame: Change measures in 0,6,12 month
Secondary outcomes:
measure: changes in depression,Beck Depression Inventory (BDI)
timeFrame: Change measures in 0,6,12 month
measure: changes quality of life.Multiple sclerosis impact scale - 29 items(MSIS29)
timeFrame: Change measures in 0,6,12 month
measure: changes in quality of sleep.Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change measures in 0,6,12 month
measure: changes in fatigue.Fatigue Severity Scale (FSS)
timeFrame: Change measures in 0,6,12 month
Other outcomes:
Locations:
city: Paris
country: France
facility: university Paris Nanterre
Study officials:
affiliation: university paris Nanterre
name: Marie claire GAY, full prof
role: STUDY_DIRECTOR
affiliation: Isfahan university of medical science
name: vahid shaygannejad, professor
role: STUDY_DIRECTOR
affiliation: university paris Nanterre
name: AZAM Mansourzadeh
role: PRINCIPAL_INVESTIGATOR
References: