Multiple Sclerosis Clinical Trial

Meeting an Unmet Need in Multiple Sclerosis

Summary

The primary objectives of this study is to examine the efficacy of the Unified Protocol in decreasing depression and anxiety among individuals with MS and the secondary outcomes (e.g., improved well-being, QOL, coping, etc.) that may occur in tandem.

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Full Description

The primary objectives of this study is to examine the efficacy of the Unified Protocol in decreasing depression and anxiety among individuals with MS and the secondary outcomes (e.g., improved well-being, QOL, coping, etc.) that may occur in tandem.

To achieve this, the investigation has the following specific aims:

Specific Aim 1: Conduct a pilot Randomized Controlled Trial (RCT) of the Unified Protocol among individuals with MS to determine the effectiveness of the intervention in reducing depression and anxiety.

Hypothesis 1: Individuals who participate in the Unified Protocol intervention will report a decrease in their depression and anxiety compared to individuals in the control group.

Specific Aim 2: Conduct a pilot RCT of the Unified Protocol among individuals with MS to determine the effectiveness of the intervention in improving secondary outcomes of psychological well-being, QOL, coping, and MS symptomatology over time.

Hypothesis 2: Individuals who participate in the Unified Protocol intervention will report an increase in psychological well-being, QOL, coping, and MS symptomatology over time compared to participants in the control group.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of multiple sclerosis
18 years of age or older
Experiencing significant depression and/or anxiety
English-speaking
Able to provide informed consent
Access to the internet

Exclusion Criteria:

History of any other neurological illness (e.g. traumatic brain injury, epilepsy, dementia)
Current participation in another randomized controlled trial
Cognitive impairment that would affect my ability to fully participate in the group
Unable to attend group sessions
Active participation in another formal clinical group or psychological therapy
Any other medical or psychological condition that, in the judgement of the investigators, prevents successful participation in the study

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

24

Study ID:

NCT05953519

Recruitment Status:

Recruiting

Sponsor:

Kessler Foundation

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There is 1 Location for this study

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Kessler Foundation
East Hanover New Jersey, 07936, United States More Info
Belinda Washington, B.A.
Contact
973-324-8446
[email protected]
Lauren B Strober, PhD
Contact
973-324-8459
[email protected]
Lauren Strober, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

24

Study ID:

NCT05953519

Recruitment Status:

Recruiting

Sponsor:


Kessler Foundation

How clear is this clinincal trial information?

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