Meeting an Unmet Need in Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Unified Protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |