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Meeting an Unmet Need in Multiple Sclerosis

Meeting an Unmet Need in Multiple Sclerosis

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Multiple Sclerosis

NCT05953519

Kessler Foundation

26 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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