Emotion-focused cost-effective cognitive behavioral intervention for m
Efficacy of unified protocol on difficulties with emotional regulation in people with multiple sclerosis and depression or anxiety disorder
What it found
We found no results in the registry or in papers.
This trial finished 6 years ago. We found no results in the registry or in any paper that cites it.
What it measured
Main measures
At baseline, post-treatment (14-weeks), and three months: 1. Psychological or psychiatric diagnosis assessed using SCID-DSM-IV: The Structured Clinical Interview for DSM-IV (SCID) 2. Tendency, intensity and excessiveness of worry assessed using the Penn State Worry Questionnaire (PSWQ) 3. Anxiety symptoms assessed using the Hospital Anxiety and Depression Scale (HADS) anxiety subscale 4. Depressio
Mood and sleep
Other measures (1)
Current secondary outcome measures as of 08/11/2019: 1. Mindfulness (mindful observation, non-aversion, non-judgment, and letting go) assessed using the Southampton Mindfulness Questionnaire (SMQ) 2. Emotionality assessed using the Emotional style Questionnaire (2019) ESQ 3. Depression symptoms assessed using the Beck Depression Inventory 4. Emotional dysregulation assessed using the Difficultie
Mood and sleep
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
Inclusion: Current inclusion criteria as of 08/11/2019: 1. Valid MS diagnosis 2. No suicidal Ideation or threatening behaviors, no history span attempted suicide 3. Valid diagnosis of depression or anxiety disorder 4. Internet availability Previous inclusion criteria: 1. Diagnosis of MS for 3 years or more 2. Fluent in Persian 3. 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 each of screening domains: 5.1 Anxiety screening measures included the Penn State Worry Questionnaire (PSWQ), Anxiety Severity and Impairment Scale (OASIS). HADS-A 5.2 Depression screening measures include Anxiety Severity and Impairment Scale ODSIS HADS-D. 5.3 Emotional screening measures include Difficulties in Emotion Regulation Scale (DERS), the Positive and Negative Affect Schedule (PANAS), the Southampton Mindfulness Questionnaire (SMQ), and Emotion Regulation Questionnaire (ERQ-R). 6. Willing to participate in the research 7. Fill and sign consent 8. Medical agreement for participation. Exclusion: 1. Initial diagnosis of current or past schizophrenia, psychosis, or organic mental disorder, bipolar disorder, or organic mental disorder 2. Other Chronic physical illnesses (such as insulin-dependent diabetes and chemotherapy for cancer) 3. Pregnancy or lactation 4. Drug abuse history or drug dependence except for nicotine 5. Absenteeism for more than three sessions 6. Receiving psychological interventions during previous year 7. Presence of another comorbid neurological disorder such as Alzheimer's disease, Parkinson's disease or dementia
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 (central nervous system). In MS, the immune system attacks the protective sheath (myelin) that covers nerve fibers and causes communication problems between your brain and the rest of your 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 of remission without any new symptoms. In addition to physical impairment, a broad range of mental and emotional problems are typical in this condition. Unfortunately, some patients focus only on physical symptoms, and they do not pay attention to psychological consequences. We call it MS focus. Emotional problems are more widespread in people with MS. This study aims to investigate the effect of psychological therapy on mental health problems related to MS. Who can participate? All MS patients over 18 years old What does the study involve? All participants will first take part in an interview with the psychologist to learn about their current mental health and coping strategies. Participants will then be randomly assigned to receive either a psychological group intervention for coping with MS, or will receive treatment as usual. The therapy consists of 14 weekly 2-hour sessions with a 15-min break after 60 min. After 14-weeks, and again three months later, all participants will have another interview with the psychologist. What are the possible benefits and risks of participating? Benefits: The therapy may contribute to an improvement in mental health. Risks: None Where is the study run from? Farshchian Hospital, Hamedan, Iran When is the study starting and how long is it expected to run for? November 2019 to January 2020 (updated 08/11/2019, previously: August 2019 to September 2019) Who is funding the study? National Institute for Medical Research Development, Iran (updated 08/11/2019, previously: Islamic Azad University of Hamedan, Iran) Who is the main contact? Mr Nabi Nazari naviddrphd@gmail.com
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History
Started
Nov 2019
Finished
Jan 2020