Meeting an Unmet Need in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Meeting an Unmet Need in Multiple Sclerosis (MS): An Evaluation of the Effectiveness of a Transdiagnostic Psychological Treatment and Its Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05953519
• Other study ID #: E-1205-23
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: July 2023
• Source: Kessler Foundation
• Contact: Belinda L Washington, BA
• Phone: 973-324-8446
• Email: bwashington[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Unified Protocol
The Unified Protocol is a transdiagnostic intervention developed to treat depression and anxiety.

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression Scale (HADS) - Change in Depression	Self-report measure of depression. Scores range from 0-21 with higher scores indicating greater depression.	Baseline, 12 weeks, 24 weeks
Primary	Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety	Self-report measure of anxiety. Scores range from 0-21 with higher scores indicating greater anxiety.	Baseline, 12 weeks, 24 weeks
Secondary	Modified Fatigue Impact Scale (MFIS) - Change in Fatigue	Self-report measure of fatigue. Scores range from 0-84 with higher scores indicating greater fatigue.	Baseline, 12 weeks, 24 weeks
Secondary	Pittsburgh Sleep Quality Index (PQSI) - Change in Sleep	Self-report measure of sleep. Scores range from 0-21 with higher scores indicating greater sleep problems.	Baseline, 12 weeks, 24 weeks
Secondary	MOS Pain Effects Scale (PES) - Change in Pain	Self-report measure of pain. Scores range from 0-30 with higher scores indicating greater pain.	Baseline, 12 weeks, 24 weeks
Secondary	General Self-Efficacy Scale (GSES) - Change in Self-efficacy	Self-report measure of self-efficacy. Scores range from 10-40 with higher scores indicating greater self-efficacy.	Baseline, 12 weeks, 24 weeks
Secondary	University of Washington Self-Efficacy Scale - Change in MS specific self-efficacy	Self-report measure of disease self-efficacy. Scores range from 0-100 (T-scores) with higher scores indicating greater self-efficacy.	Baseline, 12 weeks, 24 weeks
Secondary	University of Washington Resilience Scale - Change in Resilience	Self-report measure of resilience. Scores range from 8-40 with higher scores indicating greater resilience.	Baseline, 12 weeks, 24 weeks
Secondary	COPE inventory - Change in Coping	Self-report measure of coping. Scores range from 4-16 for each coping scale with higher scores indicating greater coping.	Baseline, 12 weeks, 24 weeks
Secondary	Benefit Finding in Multiple Sclerosis (BFIMS) - Change in Benefit-finding	Self-report measure of positive coping. Scores range from 43-129 for the total scale with higher scores indicating greater benefit-finding.	Baseline, 12 weeks, 24 weeks
Secondary	Satisfaction with Life Scale (SWLS) - Changes in Quality of Life	Self-report measure of quality of life and satisfaction. Scores range from 5-35 with higher scores indicating greater life satisfaction.	Baseline, 12 weeks, 24 weeks
Secondary	Flourishing Scale (FS) - Change in Quality of Life	Self-report measure of quality of life. Scores range from 8-56 with higher scores indicating greater quality of life.	Baseline, 12 weeks, 24 weeks
Secondary	Ryff Psychological Well-being Scales (RYFFPWB) - Changes in well-being	Self-report measure of psychological well-being. Scores range from 14-84 for each subscale with higher scores indicating greater psychological well-being.	Baseline, 12 weeks, 24 weeks