NCT04030819

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.

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
106

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Dec 2018

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

December 20, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

July 11, 2019

Last Update Submit

July 27, 2019

Conditions

Anxiety

Keywords

anxietymultiple sclerosisschema therapy

Outcome Measures

Primary Outcomes (2)

  • changes Anxiety in patient with MS,Beck Anxiety Inventory (BAI)

    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

    Change measures in 0,6,12 month

  • changes in level of cortisol

    cortisol measure by Immunoassay by cortisol saliva ELISA, DiaMetra ( kit),adult morning peak :3-10 ,higher values represent more anxiety

    Change measures in 0,6,12 month

Secondary Outcomes (4)

  • changes in depression,Beck Depression Inventory (BDI)

    Change measures in 0,6,12 month

  • changes quality of life.Multiple sclerosis impact scale - 29 items(MSIS29)

    Change measures in 0,6,12 month

  • changes in quality of sleep.Pittsburgh Sleep Quality Index (PSQI)

    Change measures in 0,6,12 month

  • changes in fatigue.Fatigue Severity Scale (FSS)

    Change measures in 0,6,12 month

Study Arms (2)

control group

NO INTERVENTION

no intervention

experimental group

EXPERIMENTAL

schema therapy

Behavioral: schema therapy

Interventions

schema therapyBEHAVIORAL

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

experimental group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

university Paris Nanterre

Paris, 75, France

Location

MeSH Terms

Conditions

Anxiety DisordersMultiple Sclerosis

Interventions

Schema Therapy

Condition Hierarchy (Ancestors)

Mental DisordersDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marie claire GAY, full prof

    university paris Nanterre

    STUDY DIRECTOR

  • vahid shaygannejad, professor

    Isfahan university of medical science

    STUDY DIRECTOR

  • AZAM Mansourzadeh

    university paris Nanterre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD student of university Nanterre-clinical researcher in university ISFAHAN

Study Record Dates

First Submitted

July 11, 2019

First Posted

July 24, 2019

Study Start

December 20, 2018

Primary Completion

June 18, 2019

Study Completion

December 15, 2019

Last Updated

July 30, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)