Effectiveness of a Schema Therapy on Anxiety in Patients With Multiple

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)

Status unknownNot a drug-phase studyRelapsing MSNCT04030819

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • schema therapy

What it measured

Main measures

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

    Change measures in 0,6,12 month

    Mood and sleep

  • changes in level of cortisol

    Change measures in 0,6,12 month

    Mood and sleep

Other measures (4)

  • changes in depression,Beck Depression Inventory (BDI)

    Change measures in 0,6,12 month

    Mood and sleep

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

    Change measures in 0,6,12 month

    Quality of life (reported by participants)

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

    Change measures in 0,6,12 month

    Mood and sleep

  • changes in fatigue.Fatigue Severity Scale (FSS)

    Change measures in 0,6,12 month

    Fatigue

Who could take part

Relapsing MS · 18 and over

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Dec 2018

    2. Main results due

      Jun 2019

    3. Finished

      Dec 2019

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