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AnxietyNCT04030819

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

A study testing schema therapy in people with Anxiety, run by Paris Nanterre University at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Anxiety
What is being tested?
schema therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteFrance
Study dates
20 Dec 2018to 15 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • expanded Disability Status Scale score less than 6
  • ability reading and writing Persian
  • Non hospitalized

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • university Paris Nanterre

    Paris, 75

Other trials in France

About this study

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)

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.

Read the 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
Being tested
schema therapy
Keywords
anxiety, multiple sclerosis, schema therapy
Medical subject headings
Anxiety Disorders, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • schema therapyBehavioural

    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

Study groups in NCT04030819
Study groupRoleWhat they receive
control groupNo interventionno intervention
experimental groupExperimentalschema therapy
Receives: Behavioral: schema therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Change measures in 0,6,12 month

  2. 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

    Measured: Change measures in 0,6,12 month

Secondary outcomes (4)

  1. changes in depression,Beck Depression Inventory (BDI)

    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

    Measured: Change measures in 0,6,12 month

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

    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).

    Measured: Change measures in 0,6,12 month

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

    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..

    Measured: Change measures in 0,6,12 month

  4. changes in fatigue.Fatigue Severity Scale (FSS)

    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

    Measured: Change measures in 0,6,12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2019
  2. Study start20 Dec 2018
  3. Primary completion18 Jun 2019
  4. Study completion15 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04030819
Sponsor's protocol ID
ParisNU
Status last verified
Jul 2019
First submitted
11 Jul 2019
Last updated
30 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing schema therapy in people with Anxiety, run by Paris Nanterre University at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes Anxiety in patient with MS,Beck Anxiety Inventory (BAI) (time frame: Change measures in 0,6,12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04030819.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.

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