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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

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

~390

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor

174 Previous Clinical Trials

10,714 Total Patients Enrolled

32 Trials studying Multiple Sclerosis

1,593 Patients Enrolled for Multiple Sclerosis

Media Library

Unified Protocol (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05953519 — N/A

Multiple Sclerosis Research Study Groups: Unified Protocol intervention, Control group

Multiple Sclerosis Clinical Trial 2023: Unified Protocol Highlights & Side Effects. Trial Name: NCT05953519 — N/A

Unified Protocol (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05953519 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are engaged in this investigational endeavor?

"Affirmative. Clinicaltrials.gov reveals that this trial, which was initially posted on April 10th 2023, is currently looking for participants. 24 volunteers will be accepted at one medical centre."

Answered by AI

Are there currently any vacancies for this research project?

"Affirmatively, clinicaltrials.gov confirms that the trial is recruiting as of July 12th, 2023. It was first announced on April 10th and seeks 24 participants from one site."

Answered by AI

What are the projected benefits of this clinical research?

"The primary objective of this medical experiment, which will be monitored over a three-stage interval (Baseline, 12 weeks and 24 weeks), is to gauge the variation in anxiety via the Hospital Anxiety and Depression Scale. Additional secondary outcomes are assessed by means of self-reported surveys; these include alterations in sleep quality calculated through Pittsburgh Sleep Quality Index scores from 0-21 with higher numbers signifying more significant slumber issues; MOS Pain Effects Scale evaluates pain levels with values ranging from 0 - 30 where greater figures denote increased discomfort; lastly, General Self-Efficacy Scale examines changes in self-efficacy using ratings between 10 -"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Meeting an Unmet Need in Multiple Sclerosis

Lauren Strober 2023. "Meeting an Unmet Need in Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05953519.