Meeting an Unmet Need in Multiple Sclerosis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Unified Protocol

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Belinda L Washington, BA; Phone Number: 973-324-8446; Email: bwashington@kesslerfoundation.org
• Study Contact Backup: Name: Lauren B Strober, PhD; Phone Number: 973-324-8459; Email: lstrober@kesslerfoundation.org

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Recruiting
      • Kessler Foundation
      • Principal Investigator: Lauren Strober, PhD
      • Contact: Lauren B Strober, PhD; Phone Number: 973-324-8459; Email: lstrober@kesslerfoundation.org
      • Contact: Belinda Washington, B.A.; Phone Number: 973-324-8446; Email: bwashington@kesslerfoundation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unified Protocol 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.	Behavioral: Unified Protocol; The Unified Protocol is a transdiagnostic intervention developed to treat depression and anxiety.
No Intervention: Control group; The control group will not receive any intervention and will complete the same baseline and follow-up assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: E-1205-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No