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Application of shared Mechanism Therapies on Emotion in Patient With Chronic disease With Comorbidity
Last registered on August 14, 2019

Pre-Trial

Trial Information
General Information
Title
Application of shared Mechanism Therapies on Emotion in Patient With Chronic disease With Comorbidity
RCT ID
AEARCTR-0004435
Initial registration date
July 11, 2019
Last updated
August 14, 2019 12:43 AM EDT
Location(s)
Primary Investigator
Affiliation
Other Primary Investigator(s)
Additional Trial Information
Status
Completed
Start date
2018-11-09
End date
2019-08-10
Secondary IDs
Regulation and emotion regulation
Abstract
Abstract
The objective of this study was to investigate the effectiveness of The Application of shared Mechanism Therapies on Emotion in Patient With Chronic disease With Comorbidity
Anxiety is highly comorbid with depression, but little is known about the impact of anxiety disorders on the effectiveness of empirically supported psychotherapies for depression. We examined such outcomes for people.The prevalence of both anxiety and depressive the group examined in this study, in which lifetime prevalence and MDD is around 50% . As in medically healthy people, the consequences of these disorders for people with MS include higher risk for suicide .
External Link(s)
Registration Citation
Citation
nazari, nabi. 2019. "Application of shared Mechanism Therapies on Emotion in Patient With Chronic disease With Comorbidity." AEA RCT Registry. August 14. https://doi.org/10.1257/rct.4435-18.0.
Former Citation
nazari, nabi. 2019. "Application of shared Mechanism Therapies on Emotion in Patient With Chronic disease With Comorbidity." AEA RCT Registry. August 14. https://www.socialscienceregistry.org/trials/4435/history/51713.
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)

The purpose of this study was to assess the efficacy of the Application of shared Mechanism Therapies cognitive behavior therapy (CBT) as a treatment for multiple sclerosis (MS) fatigue on Emotion in Patient With Chronic disease With Comorbidity . A randomized controlled design was used where 72 patients with MS fatigue were randomly assigned to 14 weekly sessions of tCBT . Participants were assessed before and after treatment, and at 3 months after post-treatment.
Intervention Start Date
2019-03-02
Intervention End Date
2019-05-06
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 at least 18 years of age
2. Fluent in Persian,
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 breast feeding
4. Evidence of current or past schizophrenia, psychosis, or organic mental disorder, bipolar disorder, or organic mental disorder
6. Drug abuse history
7. Absenteeism

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 moderate interaction effect (f = 0.45) between group and time alpha of 0.05, a power of 0.80,
Supporting Documents and Materials
Documents
Document Name
The Southampton Mindfulness Questionnaire (SMQ; Chadwick et al., 2008)
Document Type
survey_instrument
Document Description
he SMQ 16 items are scored on a 7-point Likert scale, worded ‘strongly disagree’ (0) to
‘strongly agree’ (6), yielding a total range of 0–96. Eight items are framed positively, eight
negatively. The SMQ had good internal consistency, adequate concurrent validity, discriminated between meditators, non-meditators and those with a psychosis, and was significantly correlated with mood rating. Data indicated a single
factor structure. Those with currently distressing psychosis were less mindful than non-clinical participants (mediators or non mediators), with degree of mindfulness inversely related to intensity of delusional experience
Document Name
SCID-DSM-IV
Document Type
other
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

MD5:

SHA1:

Uploaded At: July 11, 2019

IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
ethics commite of islamic AZAD university
IRB Approval Date
2019-08-01
IRB Approval Number
IR.MS.REC
Analysis Plan
Analysis Plan Documents
Table& analyze

MD5: 163ed2473a1409ce2f98854829eb53b1

SHA1: a261cadcef88013c3ffe0ba4c8d7d522ade13d1c

Uploaded At: August 04, 2019

Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
Yes
Intervention Completion Date
February 01, 2019, 12:00 AM +00:00
Is data collection complete?
Yes
Data Collection Completion Date
April 15, 2019, 12:00 AM +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 and Papers
Preliminary Reports
Relevant Papers