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

Sponsor

Paris Nanterre University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04030819

Collaborator

Isfahan University of Medical Sciences (Other)

106

Enrollment

Location

Arms

11.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Behavioral: schema therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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)

Actual Study Start Date :

Dec 20, 2018

Actual Primary Completion Date :

Jun 18, 2019

Anticipated Study Completion Date :

Dec 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control group no intervention
Experimental: experimental group schema therapy	Behavioral: 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

Arm

Intervention/Treatment

No Intervention: control group

no intervention

Experimental: experimental group

schema therapy

Behavioral: 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

Outcome Measures

Primary Outcome Measures

changes Anxiety in patient with MS,Beck Anxiety Inventory (BAI) [Change measures in 0,6,12 month]
Beck Anxiety Inventory (BAI),self-reported questionnaire of anxiety,.21-question multiple- choice each answer being scored on a scale value of 0 (not at all) to 3 (severely),Higher total scores indicate more severe anxiety symptoms . score between 0-63
changes in level of cortisol [Change measures in 0,6,12 month]
cortisol measure by Immunoassay by cortisol saliva ELISA, DiaMetra ( kit),adult morning peak :3-10 ,higher values represent more anxiety

Secondary Outcome Measures

changes in depression,Beck Depression Inventory (BDI) [Change measures in 0,6,12 month]
Beck Depression Inventory (BDI)- self report questionnaires,21-question multiple-choice,each answer being scored on a scale value of 0 (not at all) to 3 (severely),total scores indicate more severe depression symptoms . score between 0-63
changes quality of life.Multiple sclerosis impact scale - 29 items(MSIS29) [Change measures in 0,6,12 month]
Multiple sclerosis impact scale - 29 items.self -reported questionnaires (MSIS29):29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale,Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health).
changes in quality of sleep.Pittsburgh Sleep Quality Index (PSQI) [Change measures in 0,6,12 month]
Pittsburgh Sleep Quality Index (PSQI) : self-report questionnaire that assesses sleep quality over a 1-month time intervalself-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items,Each item is weighted on a 0-3 interval scale The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality..
changes in fatigue.Fatigue Severity Scale (FSS) [Change measures in 0,6,12 month]
Fatigue Severity Scale (FSS). self -reported questionnaires The FSS questionnaire contains nine statements that attempt to explore severity of fatigue symptoms.each item being scored on a scale value of 1 to 7. score between 9-63.higher the score indicate greater fatigue

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	university Paris Nanterre	Paris		France	75

Sponsors and Collaborators

Paris Nanterre University
Isfahan University of Medical Sciences

Investigators

Study Director: Marie claire GAY, full prof, university paris Nanterre
Study Director: vahid shaygannejad, professor, Isfahan university of medical science
Principal Investigator: AZAM Mansourzadeh, university paris Nanterre