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Effectiveness of a Schema Therapy on Anxiety in Patients With Multiple Sclerosis
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anxiety | Behavioral: schema therapy | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| 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 : | December 20, 2018 |
| Actual Primary Completion Date : | June 18, 2019 |
| Estimated Study Completion Date : | December 15, 2019 |
| 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
|
- changes Anxiety in patient with MS,Beck Anxiety Inventory (BAI) [ Time Frame: 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 [ Time Frame: 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
- changes in depression,Beck Depression Inventory (BDI) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
| France | |
| university Paris Nanterre | |
| Paris, France, 75 | |
| 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 |
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 11, 2019 | |||||||||
| First Posted Date ICMJE | July 24, 2019 | |||||||||
| Last Update Posted Date | July 30, 2019 | |||||||||
| Actual Study Start Date ICMJE | December 20, 2018 | |||||||||
| Actual Primary Completion Date | June 18, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Effectiveness of a Schema Therapy on Anxiety in Patients With Multiple Sclerosis | |||||||||
| Official Title ICMJE | 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) | |||||||||
| 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. |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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| Condition ICMJE | Anxiety | |||||||||
| Intervention ICMJE | 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
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Active, not recruiting | |||||||||
| Actual Enrollment ICMJE |
106 | |||||||||
| Original Actual Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | December 15, 2019 | |||||||||
| Actual Primary Completion Date | June 18, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | Yes | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | France | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT04030819 | |||||||||
| Other Study ID Numbers ICMJE | ParisNU | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Azam Mansourzadeh, Paris Nanterre University | |||||||||
| Study Sponsor ICMJE | Paris Nanterre University | |||||||||
| Collaborators ICMJE | Isfahan University of Medical Sciences | |||||||||
| Investigators ICMJE |
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| PRS Account | Paris Nanterre University | |||||||||
| Verification Date | July 2019 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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