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

Last registered on July 30, 2019

Pre-Trial

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, 5:22 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)

Additional Trial Information

Status

Completed

Start date

2017-12-01

End date

2019-06-01

Keywords

Education, Health, Other

Additional Keywords

Multiple Sclerosis, Transdiagnostic Group Therapy

JEL code(s)

Efficacy of Transdiagnostic Group Therapy

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.4435-8.0

Former Citation

Sponsors & Partners

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

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

Experimental Design Details

Randomization Method

computerized The block size of 6

Randomization Unit

individual

Was the treatment clustered?

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 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) ). 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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