Effectiveness of an emotion-focused behavioral treatment program for adults with multiple sclerosis

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN95459505

Enrollment

Registered

2019-09-26

Start date

2019-05-01

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Emotional regulation difficulties in people with multiple sclerosis and associated depression or anxiety disorder Mental and Behavioural Disorders

Interventions

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 rec

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Iran

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026