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Behavioral Intervention

Unified Protocol for Multiple Sclerosis

N/A

Recruiting

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 weeks, 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will examine how well a therapy can help reduce depression and anxiety in people with multiple sclerosis, and how it can improve their quality of life.

Who is the study for?

This trial is for adults over 18 with multiple sclerosis who are dealing with significant depression or anxiety. Participants must speak English, be able to consent, and have internet access. It's not for those with cognitive impairments that affect group participation, other major neurological illnesses, or those already in a different clinical group therapy or trial.

What is being tested?

The study is testing the Unified Protocol to see if it can reduce depression and anxiety in people with MS. It also looks at whether this treatment improves overall well-being, quality of life (QOL), and coping strategies.

What are the potential side effects?

Since the Unified Protocol involves psychological therapy rather than medication, typical side effects associated with drugs may not apply. However, participants might experience emotional discomfort discussing personal issues during sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 weeks, 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 weeks, 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks, 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety

Hospital Anxiety and Depression Scale (HADS) - Change in Depression

Secondary study objectives

Benefit Finding in Multiple Sclerosis (BFIMS) - Change in Benefit-finding

COPE inventory - Change in Coping

Flourishing Scale (FS) - Change in Quality of Life

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Unified Protocol interventionExperimental Treatment1 Intervention

The Unified Protocol consists of 12-weeks, virtual, group sessions focused on reducing depression and anxiety through: (1) Increasing emotional awareness; (2) Cognitive restructuring against dysfunctional beliefs; (3) Changing action tendencies associated with disordered emotions; (4) Preventing emotional avoidance and utilizing emotion exposure techniques; (5) Providing mutual help among group members; and (6) Providing opportunities for corrective experiences.

Group II: Control groupActive Control1 Intervention

The control group will not receive any intervention and will complete the same baseline and follow-up assessments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Unified Protocol

2020

N/A

~410

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