Condition category
Mental and Behavioural Disorders
Date applied
15/09/2019
Date assigned
26/09/2019
Last edited
02/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Multiple sclerosis (MS) is a potentially disabling disease of the brain and spinal cord. In MS, the immune system attacks the protective myelin sheath that covers nerve fibers. This results in communication problems between the brain and the rest of the body. Eventually, the disease can cause permanent damage or deterioration of the nerves. Signs and symptoms of MS vary widely and depend on the amount of nerve damage and which nerves are affected. Some people with severe MS may lose the ability to walk independently or at all, while others may experience long periods without any new symptoms.
In addition to physical problems, a broad range of mental and emotional problems can occur in this condition. Some patients focus only on physical symptoms, and do not pay attention to psychological consequences. Emotional problems are more widespread in people with MS.
The Unified Protocol is a new psychological transdiagnostic intervention based on cognitive behavioural therapy (CBT) that helps people learn how to face inappropriate emotions and respond to their emotions in a more adaptive way. This method tries to reduce the intensity and frequency of emotional habits by adjusting the person's emotional ordering habits, increasing their emotional functioning.

Who can participate?
Adults who have had MS for at least 3 years and who have anxiety and depression.

What does the study involve?
Participants will be randomly allocated to one of two groups. One group will receive treatment as usual from their hospital and doctor. This involves no behavioural therapy. The other group will receive treatment as usual as well as the Unified Protocol behavioural therapy. This will involve 12-14 weekly sessions with a therapist that will aim to increase participants' awareness of their emotions and ability to manage emotions.

What are the possible benefits and risks of participating?
There are no risks associated with participating. At each visit, the mental health of the participant is assessed. There is also a 24-hour helpline available to participants. Those in the Unified Protocol group might benefit from learning to cope better with their illness.

Where is the study run from?
Azad University (Iran)

When is the study starting and how long is it expected to run for?
March 2019 to October 2019

Who is funding the study?


Who is the main contact?
Dr Nabi Nazari, nnpilotiriaf@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nabi Nazari

ORCID ID

http://orcid.org/0000-0003-3771-3699

Contact details

Lorestan University
Kamalvand St
Khorramabad
6554567654
Iran
009809379189027
NNPILOTIRIAF@Gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1265491

Study information

Scientific title

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

Acronym

EUPDERPMSDAIRCT

Study hypothesis

Transdiagnostic Group Therapy improves emotion regulation and reduces difficulties in emotion regulation in adults with MS.

Ethics approval

Approved 20/02/2019, WIRBRMC (PO Box 6545676545, Vali-Asr Ave, Tehran, Iran; +98 021 883232333; info@wirbrmc.com); ref: wirb IR 20192297 LO

Study design

Single-blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

See additional files

Condition

Emotional regulation difficulties in people with multiple sclerosis and associated depression or anxiety disorder

Intervention

Immediately after randomization using a random digits table, participants in the experimental group will receive the Unified Protocol for Adolescents (UP-A) for 12-14 weeks. The control group will receive treatment as usual, which involves no behavioural treatment.
The UP-A sessions are delivered in a flexible manner. Several of the UPs treatment elements are fixed and received by all participants (psychoeducation about emotions and emotional behavior, awareness and mindfulness skills, antecedent cognitive reappraisal/problem-solving skills, emotion exposure strategies, and relapse prevention skills), although applied for varying numbers of sessions depending on clinical need. Other strategies (motivational enhancement, parenting strategies and crisis management strategies) are applied on an as-needed basis based on client needs.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Depression assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline, after the end of the intervention and 3 months after the end of the intervention
2. Anxiety assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline, after the end of the intervention and 3 months after the end of the intervention
3. Emotion regulation difficulties assessed using the Difficulties in Emotion Regulation Scale (DERS) at at baseline, after the end of the intervention and 3 months after the end of the intervention

Secondary outcome measures

1. Extent of emotion regulation difficulty assessed using the Difficulties in Emotion Regulation Scale (DERS) at baseline, after the end of the intervention and 3 months after the end of the intervention
2. Positive and negative affect assessed using the Positive and Negative Affect Schedule (PANAS) at baseline, after the end of the intervention and 3 months after the end of the intervention
3. Mindful awareness of distressing thoughts and images assessed using the Southampton Mindfulness Questionnaire (SMQ) at baseline, after the end of the intervention and 3 months after the end of the intervention
4. Use of emotional regulation strategies assessed using the Emotion Regulation Questionnaire (ERQ-R) at baseline, after the end of the intervention and 3 months after the end of the intervention

Overall trial start date

01/03/2019

Overall trial end date

21/10/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

98

Participant exclusion criteria

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

Recruitment start date

01/05/2019

Recruitment end date

01/06/2019

Locations

Countries of recruitment

Iran

Trial participating centre

Iranian MS Association
PO Box 63654852001
Tehran
-
Iran

Trial participating centre

Sina Hospital
Imam Square
Tehran
-
Iran

Sponsor information

Organisation

Islamic Azad University

Sponsor details

Hesaarak Square
Tehran
Tehran
-
Iran
-
manavipor53@hotmail.com

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Islamic Azad University

Alternative name(s)

IAU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Iran

Results and Publications

Publication and dissemination plan

Planned publication in a peer-reviewed journal.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication and are available on request from the investigators.

Intention to publish date

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/10/2019: The overall end date was changed from 01/10/2019 to 21/10/2019. 27/09/2019: The participant information sheet has been uploladed. 24/09/2019: Trial's existence confirmed by WIRB.