Efficacy of the Unified Protocol on difficulties with emotional regulation in people with multiple sclerosis and associated depression or anxiety disorder: a randomized controlled trial

Islamic Azad University0 sites64 target enrollmentSeptember 26, 2019

Overview

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33129298/ results (added 03/11/2020)

Registry

who.int

Start Date

September 26, 2019

End Date

October 21, 2019

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Diagnosis of MS for 3 years or more
•2\. Fluent in Persian
•3\. Aged at least 18 years
•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.
•4\. Received at least one self\-report score outside the cut\-off range specified for screening measures for anxiety (using the HADS\-A scale) and depression (using the HADS\-S scale
•5\. Willing to participate in the research
•6\. Completed and signed consent form
•7\. Medical MS agreement for participation

•1\. Co\-occurring conditions, including positive diagnosis of schizophrenia, bipolar I or II disorder, pervasive developmental disorder, organic brain syndrome, mental retardation , or current suicidal/homicidal ideation
•2\. A prior course of cognitive behavioral treatment during the previous year
•3\. Other chronic physical illnesses (such as insulin\-dependent diabetes and chemotherapy for cancer)
•4\. Pregnancy or lactation
•5\. 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