Emotion-focused cost-effective cognitive behavioral intervention for multiple sclerosis

Not Applicable

Completed

• Conditions: Anxiety and depression in patients with multiple sclerosis; Mental and Behavioural Disorders

• Registration Number: ISRCTN16135866
• Lead Sponsor: Islamic Azad University of Hamedan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-07
• Study Completion: 2020-01-08
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> At baseline, post-treatment (14-weeks), and three months:<br> 1. Psychological or psychiatric diagnosis assessed using SCID-DSM-IV: The Structured Clinical Interview for DSM-IV (SCID)<br> 2. Tendency, intensity and excessiveness of worry assessed using the Penn State Worry Questionnaire (PSWQ)<br> 3. Anxiety symptoms assessed using the Hospital Anxiety and Depression Scale (HADS) anxiety subscale<br> 4. Depression symptoms assessed using the Hospital Anxiety and Depression Scale (HADS) depression subscale<br>