Effectiveness of a Schema Therapy on Anxiety in Patients With Multiple Sclerosis

NCT ID: NCT04030819

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2019-12-15

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

control group

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

experimental group

schema therapy

Group Type: EXPERIMENTAL

schema therapy

Intervention Type: BEHAVIORAL

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

Interventions

schema therapy

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Isfahan University of Medical Sciences

OTHER

Sponsor Role: collaborator

Paris Nanterre University

OTHER

Sponsor Role: lead

Responsible Party

Azam Mansourzadeh

PHD student of university Nanterre-clinical researcher in university ISFAHAN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie claire GAY, full prof

Role: STUDY_DIRECTOR

university paris Nanterre

vahid shaygannejad, professor

Role: STUDY_DIRECTOR

Isfahan university of medical science

AZAM Mansourzadeh

Role: PRINCIPAL_INVESTIGATOR

university paris Nanterre

Locations

university Paris Nanterre

Paris, , France

Countries

France

Other Identifiers

ParisNU

Identifier Type: -

Identifier Source: org_study_id