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

Efficacy of unified protocol on difficulties with emotional regulation in people with multiple sclerosis and depression or anxiety disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16135866
Enrollment
130
Registered
2019-11-07
Start date
2019-11-08
Completion date
Unknown
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety and depression in patients with multiple sclerosis Mental and Behavioural Disorders

Interventions

The study comparing a psychological group intervention, based on transdiagnostic therapy principles developed by Barlow et al. (the Unified Protocol), with a control group. Group therapy consists of 1

Sponsors

Islamic Azad University of Hamedan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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. Depression symptoms assessed using the Hospital Anxiety and Depression Scale (HADS) depression subscale

Secondary

MeasureTime frame
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 Difficulties in Emotion Regulation Scale (DERS) 5. Tendency, intensity and excessiveness of worry assessed using the Penn State Worry Questionnaire (PSWQ) Previous secondary outcome 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. Anxiety-related symptom severity and impairment assessed using the Overall Anxiety Severity and Impairment Scale (OASIS) 3. Tendency, intensity and excessiveness of worry assessed using the Penn State Worry Questionnaire (PSWQ) 5. Emotional regulation assessed using the Emotion Regulation Questionnaire (ERQ-R) 6. Positive and negative affect assessed using the Positive and Negative Affect Schedule (PANAS) 7. Mindfulness (mindful observation, non-aversion, non-judgment, and letting go) assessed using the Southampton Mindfulness Questionnaire (SMQ) 8. Emotional dysregulation assessed using the Difficulties in Emotion Regulation Scale (DERS) 9. Anxiety symptoms assessed using the Hospital Anxiety and Depression Scale (HADS) anxiety subscale 10. Depression symptoms assessed using the Hospital Anxiety and Depression Scale (HADS) depression

Countries

Iran

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026