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Application of shared Mechanism Therapies on Emotion in Patient With Chronic disease With Comorbidity

Last registered on August 08, 2019
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Pre-Trial

Trial Information

General Information

Title
Efficacy of Transdiagnostic Group Therapy on Difficulties Emotion Regulation and emotion regulation in Women with Multiple Sclerosis Associated With Depression, Anxiety disorder
RCT ID
AEARCTR-0004435
Initial registration date
July 11, 2019

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
July 16, 2019, 4:49 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
August 08, 2019, 10:27 PM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Country
Iran (Islamic Republic of)
Region
Center

Primary Investigator

Name
nabi nazari
Affiliation
Contact Primary Investigator

Other Primary Investigator(s)

PI Name
Sasani Amir
PI Affiliation
Medical faculty
Contact Investigator

Additional Trial Information

Status
On going
Start date
2018-11-09
End date
2019-08-10
Keywords
Education, Electoral, Health, Other, Welfare
Additional Keywords
Multiple Sclerosis, Transdiagnostic Group Therapy
JEL code(s)
Efficacy of Transdiagnostic Group Therapy
Secondary IDs
Regulation and emotion regulation
Abstract
Abstract
The objective of this study was to investigate the effectiveness of Transdiagnostic Group Therapy on Women with Multiple Sclerosis.
External Link(s)

Registration Citation

Citation
nazari, nabi and Sasani Amir. 2019. "Efficacy of Transdiagnostic Group Therapy on Difficulties Emotion Regulation and emotion regulation in Women with Multiple Sclerosis Associated With Depression, Anxiety disorder." AEA RCT Registry. August 08. https://doi.org/10.1257/rct.4435-14.0
Former Citation
nazari, nabi and Sasani Amir. 2019. "Efficacy of Transdiagnostic Group Therapy on Difficulties Emotion Regulation and emotion regulation in Women with Multiple Sclerosis Associated With Depression, Anxiety disorder." AEA RCT Registry. August 08. https://www.socialscienceregistry.org/trials/4435/history/51469
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)

The study was a Single-Blind
Randomized trail control
2 group
Evaluater blind
Randomization
Intervention Start Date
2019-05-02
Intervention End Date
2019-08-06

Primary Outcomes

Primary Outcomes (end points)
Transdiagnostic Therapy approach is practical in increasing emotion regulation (ERQ scores) and decreasing the difficulties in Emotion Therapy was effective in decreasing anxiety and depression symptoms and Difficulties in Emotion Regulation among subjects in the post-test stage

Primary Outcomes (explanation)
Scid
Hads
Pswq

Secondary Outcomes

Secondary Outcomes (end points)
Scid
Hads
Pswq
Ders
Erq
Secondary Outcomes (explanation)
All measures

Experimental Design

Experimental Design
The inclusion criteria included:
1. Diagnosis of MS for three years or more
2. Fluent in Persian, at least 18 years of age
4. Meet scid

5. Received at least one self-report rch.
6. Fill and signature consent
7. Medical agreement for participation




Exclusion criteria included
1. The initial diagnosis of other psychiatric diagnoses, compensatory behaviors or cleansing,
2. Other Chronic physical illnesses (such as insulin-dependent diabetes and chemotherapy for cancer)
3. Pregnancy or lactation,
4. Evidence of current or past schizophrenia, psychosis, or organic mental disorder, bipolar disorder, or organic mental disorder
6. Drug abuse history or drug dependence except for nicotine
7. Absenteeism for more than three sessions

8. Receiving psychological interventions during one last year.
9. Presence of comorbid neurological disorders such as Alzheimer, Parkinson's disease, Dementia

Experimental Design Details
Analyze of covariancet test, pair wise
I dependent test
Cl
F
P
Randomization Method
computerized The block size of 6
Randomization Unit
individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
36 clinics
Sample size: planned number of observations
130 women
Sample size (or number of clusters) by treatment arms
The sample size was calculated using G-POWER
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
The power analysis was, and a large effect size (f = 0.4) ). alpha of 0.05, a power of 0.80, interaction effect (f = 0.45) between group and time
Supporting Documents and Materials

Documents

Document Name
SCID-DSM-IV
Document Type
survey_instrument
Document Description
The Structured Clinical Interview for DSM-5 (SCID-5) is a semi-structured interview guide for making the primary DSM-IV diagnoses
File
SCID-DSM-IV
Document Name
Ders
Document Type
survey_instrument
Document Description
Grass et all 2003
6 subscale
36 item
File
Ders
Document Name
The Southampton Mindfulness Questionnaire (SMQ; Chadwick et al., 2008)
Document Type
survey_instrument
Document Description
The SMQ measures an individual’s ability to observe and accept their emotional reactions nonjudgmentally, and to let those reactions pass; scores range from 0–96.

File
The Southampton Mindfulness Questionnaire (SMQ; Chadwick et al., 2008)
Document Name
The Positive and Negative Affect Schedule (PANAS)
Document Type
survey_instrument
Document Description
comprises two mood scales, one that measures positive affect and the other, which measures the negative effect. Used as a psychometric scale, the PANAS can show relations between positive and negative affect with personality stats and traits. Ten descriptors are used for each PA scale and NA to define their meanings.
File
The Positive and Negative Affect Schedule (PANAS)
Document Name
Emotion Regulation Questionnaire (ERQ-R)
Document Type
survey_instrument
Document Description
It is a two-factor measure of emotion regulation involving six 'cognitive Reappraisal ' items that tap into the ability to redefine a situation deemed ,
File
Emotion Regulation Questionnaire (ERQ-R)

MD5: f2ac2cc80060a6efe79191fa5ab02382

SHA1: 152e9beb37f1f47e0212d054fe1f14cebe0dfd72

Uploaded At: July 11, 2019

IRB

Institutional Review Boards (IRBs)

IRB Name
ethics commite of medical university
IRB Approval Date
2019-04-04
IRB Approval Number
IR.MS.REC.198.093
Analysis Plan

Analysis Plan Documents

Table& analyze

MD5: 163ed2473a1409ce2f98854829eb53b1

SHA1: a261cadcef88013c3ffe0ba4c8d7d522ade13d1c

Uploaded At: August 04, 2019

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
February 01, 2019, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
April 15, 2019, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
64
Was attrition correlated with treatment status?
Yes
Final Sample Size: Total Number of Observations
60
Final Sample Size (or Number of Clusters) by Treatment Arms
60
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
No
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials