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

Last registered on July 30, 2019

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
July 30, 2019, 5:14 PM EDT

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

Locations

Primary Investigator

Affiliation

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2017-12-01
End date
2019-06-01
Secondary IDs
Regulation and emotion regulation
Abstract
Abstract
MS is significantly associated with psychological, behavioral, cognitive, and emotional CONSEQUENCES. 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. 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. July 30. https://doi.org/10.1257/rct.4435-6.0
Former Citation
nazari, nabi. 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. July 30. https://www.socialscienceregistry.org/trials/4435/history/50929
Experimental Details

Interventions

Intervention(s)

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,
Intervention Start Date
2018-11-02
Intervention End Date
2019-02-01

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)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

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. 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 measure, Anxiety Severity and Impairment Scale (OASIS), ODSIS, the Geriatric Depression Scale, the Penn State Worry Questionnaire (PSWQ), in addition to, Received at least one self-report score without the cut-off range specified for emotional screening measure :
Difficulties in Emotion Regulation Scale (DERS), the Positive and Negative Affect Schedule (PANAS), the Southampton Mindfulness Questionnaire (SMQ), and Emotion Regulation Questionnaire (ERQ-R).
5. Willing to participate in the research.
6. Fill and signature consent
7. Medical MS agreement for participation

The motive element plays an essential role in this treatment due to the relative difficulty of this treatment method. Therefore, this treatment was administered to those who were conscious of the content of this therapy and motivated to cope with its challenges.


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
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
250 women
Sample size (or number of clusters) by treatment arms
The sample size was calculated using the Cohen formula to measure the effectiveness of the interven0tion (32). Taking into account the confidence of 0.95 and the test power of .90, the results of this formula showed that 26 people are required per group. Given the probability of quitting the research and the available options, this paper was conducted on two groups of 32persons (in a total of 64 people) selected using the purposeful sampling method.
At last, 64 patients, met all inclusion criteria, were assigned to treatment and control groups using computer-generated random numbers.
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) ). using an alpha of 0.05, a power of 0.80, to determine the sample size required to detect a small to moderate interaction effect (f = 0.45) between group and time
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number
Analysis Plan

Analysis Plan Documents

resul pretest post test follow up

MD5: 125f2837301816b24324f015a1e6255e

SHA1: efd2a33b29b93e75c69ec0241163c980483e1068

Uploaded At: July 11, 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