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Fields Changed

Registration

Field Before After
Trial Status completed on_going
Trial Start Date December 01, 2017 November 09, 2018
Trial End Date June 01, 2019 August 10, 2019
Last Published July 30, 2019 05:27 PM August 04, 2019 07:32 AM
Intervention (Public) The study was a Single-Blind, Randomized Controlled Trial comparing psychological intervention group, based on Transdiagnostic therapy principles, with a control group. The statistical population consisted of all females with MS living in Capital and around. First, a group of 400 females with MS who officially registered in MS clinics from October 2010 to October 2016, was selected. They invited over telephone, emails, and were notified about a summary of the objectives of the study. The study was a Single-Blind Randomized trail control 2 group Evaluater blind Randomization
Intervention Start Date November 02, 2018 May 02, 2019
Intervention End Date February 01, 2019 August 06, 2019
Primary Outcomes (Explanation) Scid Hads Pswq
Experimental Design (Public) The inclusion criteria included: 1. Diagnosis of MS for three years or more 2. Fluent in Persian, at least 18 years of age 4. Received at least one current diagnostic of a valid depression disorder and an anxiety disorder on Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fourth. Edition Axis I Disorders. 5. Received at least one self-report score without the cut-off range specified for screening measureS 5. Willing to participate in the research. 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 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
Planned Number of Observations 250 women 130 women
Keyword(s) Education, Health, Other Education, Electoral, Health, Other
Did you obtain IRB approval for this study? No Yes
Secondary Outcomes (End Points) Scid Hads Pswq Ders Erq
Secondary Outcomes (Explanation) All measures
Pi as first author No Yes
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Analysis Plans

Field Before After
Document
ggh.pdf
MD5: 163ed2473a1409ce2f98854829eb53b1
SHA1: a261cadcef88013c3ffe0ba4c8d7d522ade13d1c
Title Table& analyze
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Documents

Field Before After
Custom Type Interview
Public No Yes
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Field Before After
Custom Type ER
File
Document+_2_.docx
MD5: f2ac2cc80060a6efe79191fa5ab02382
SHA1: 152e9beb37f1f47e0212d054fe1f14cebe0dfd72
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 as emotion-eliciting so that the emotional impact is changed, and 'four expressive suppression ' items that assess the ability to control the ongoing expression of emotion. Items are based on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate more significant use of the associated strategy. It is a two-factor measure of emotion regulation involving six 'cognitive Reappraisal ' items that tap into the ability to redefine a situation deemed ,
Public No Yes
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Field Before After
Custom Type Emotion
Public No Yes
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Field Before After
Custom Type Cognitive
Public No Yes
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Field Before After
Document Name Ders
Custom Type Emotion
Description Grass et all 2003 6 subscale 36 item
Public Yes
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Irbs

Field Before After
IRB Name ethics commite of medical university
IRB Approval Date April 04, 2019
IRB Approval Number IR.MS.REC.198.093
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Other Primary Investigators

Field Before After
Affiliation Medical faculty
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Fields Removed

Analysis Plans

Field Value
Document
result+group.pdf
MD5: 125f2837301816b24324f015a1e6255e
SHA1: efd2a33b29b93e75c69ec0241163c980483e1068
Title resul pretest post test follow up
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Documents

Field Value
Document Name Difficulties in Emotion Regulation Scale (DERS
File
difficultiesinemotionalregulation_scale.pdf
MD5: 5633fcb7ab48b28a8e2eafc6413d1ae9
SHA1: 803a16a02d36dbd98664f4cb2b90fecf281fbbad
Description Calculate total score by adding everything up. Higher scores suggest greater problems with emotion regulation. SUBSCALE SCORING**: The measure yields a total score (SUM) as well as scores on six sub-scales: 1. Nonacceptance of emotional responses (NONACCEPT): 11, 12, 21, 23, 25, 29 2. Difficulty engaging in Goal-directed behavior (GOALS): 13, 18, 20R, 26, 33 3. Impulse control difficulties (IMPULSE): 3, 14, 19, 24R, 27, 32 4. Lack of emotional awareness (AWARENESS): 2R, 6R, 8R, 10R, 17R, 34R 5. Limited access to emotion regulation strategies (STRATEGIES): 15, 16, 22R, 28, 30, 31, 35, 36 6. Lack of emotional clarity (CLARITY): 1R, 4, 5, 7R, 9 Total score: sum of all subscales **”R” indicates reverse scored item REFERENCE: Gratz, K. L. & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the Difficulties
Public Yes
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