Effectiveness of an emotion-focused behavioral treatment program for adults with multiple sclerosis
| ISRCTN | ISRCTN95459505 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95459505 |
| Secondary identifying numbers | 1265491 |
- Submission date
- 15/09/2019
- Registration date
- 26/09/2019
- Last edited
- 05/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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?
Islamic 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?
Islamic Azad University (Iran)
Who is the main contact?
Dr Nabi Nazari, nnpilotiriaf@gmail.com
Contact information
Scientific
Lorestan University
Kamalvand St
Khorramabad
6554567654
Iran
 ORCID ID |
0000-0003-3771-3699 |
|---|---|
| Phone | 009809379189027 |
| NNPILOTIRIAF@Gmail.com |
Study information
| Study design | Single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | ISRCTN95459505_PIS.pdf |
| 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 |
| Study acronym | EUPDERPMSDAIRCT |
| Study objectives | Transdiagnostic Group Therapy improves emotion regulation and reduces difficulties in emotion regulation in adults with MS. |
| Ethics approval(s) | Approved 20/02/2019, WIRBRMC (PO Box 6545676545, Vali-Asr Ave, Tehran, Iran; +98 021 883232333; info@wirbrmc.com); ref: wirb IR 20192297 LO |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2019 |
| Completion date | 21/10/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 98 |
| Total final enrolment | 64 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2019 |
| Date of final enrolment | 01/06/2019 |
Locations
Countries of recruitment
- Iran
Study participating centres
Tehran
-
Iran
Tehran
-
Iran
Sponsor information
University/education
Hesaarak Square
Tehran
Tehran
-
Iran
| manavipor53@hotmail.com | |
"ROR" |
https://ror.org/01kzn7k21 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- IAU
- Location
- Iran
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 27/09/2019 | No | Yes | ||
| Basic results | 21/12/2019 | 06/01/2020 | No | No | |
| Results article | results | 31/10/2020 | 03/11/2020 | Yes | No |
| Protocol file | 05/10/2022 | No | No |
Additional files
- ISRCTN95459505_PIS.pdf
- Uploaded 27/09/2019
- ISRCTN95459505_BasicResults_21Dec2019.pdf
- Uploaded 06/01/2020
- ISRCTN95459505_PROTOCOL.pdf
Editorial Notes
05/10/2022: Uploaded protocol (not peer reviewed).
03/11/2020: Publication reference and total final enrolment number added.
06/01/2020: The basic results of this trial have been uploaded as an additional file.
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 uploaded.
24/09/2019: Trial's existence confirmed by WIRB.
