Effectiveness of an emotion-focused behavioral treatment program for a
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
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What it measured
Main measures
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 Diffi
Mood and sleep
Other measures (1)
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. Mi
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
Inclusion: 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 Exclusion: 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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
Papers
Results
Transdiagnostic treatment of emotional disorders for women with multiple sclerosis: a randomized controlled trial.BMC Womens Health · 2020
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History
Started
May 2019
Finished
Oct 2019