Meeting an Unmet Need in Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Behavioral: Unified Protocol
- Registration Number
- NCT05953519
- Lead Sponsor
- Kessler Foundation
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Unified Protocol intervention Unified Protocol 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.
- Primary Outcome Measures
Name Time Method Hospital Anxiety and Depression Scale (HADS) - Change in Depression Baseline, 12 weeks, 24 weeks Self-report measure of depression. Scores range from 0-21 with higher scores indicating greater depression.
Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety Baseline, 12 weeks, 24 weeks Self-report measure of anxiety. Scores range from 0-21 with higher scores indicating greater anxiety.
- Secondary Outcome Measures
Name Time Method University of Washington Self-Efficacy Scale - Change in MS specific self-efficacy Baseline, 12 weeks, 24 weeks Self-report measure of disease self-efficacy. Scores range from 0-100 (T-scores) with higher scores indicating greater self-efficacy.
University of Washington Resilience Scale - Change in Resilience Baseline, 12 weeks, 24 weeks Self-report measure of resilience. Scores range from 8-40 with higher scores indicating greater resilience.
COPE inventory - Change in Coping Baseline, 12 weeks, 24 weeks Self-report measure of coping. Scores range from 4-16 for each coping scale with higher scores indicating greater coping.
Pittsburgh Sleep Quality Index (PQSI) - Change in Sleep Baseline, 12 weeks, 24 weeks Self-report measure of sleep. Scores range from 0-21 with higher scores indicating greater sleep problems.
Benefit Finding in Multiple Sclerosis (BFIMS) - Change in Benefit-finding Baseline, 12 weeks, 24 weeks Self-report measure of positive coping. Scores range from 43-129 for the total scale with higher scores indicating greater benefit-finding.
Flourishing Scale (FS) - Change in Quality of Life Baseline, 12 weeks, 24 weeks Self-report measure of quality of life. Scores range from 8-56 with higher scores indicating greater quality of life.
Satisfaction with Life Scale (SWLS) - Changes in Quality of Life Baseline, 12 weeks, 24 weeks Self-report measure of quality of life and satisfaction. Scores range from 5-35 with higher scores indicating greater life satisfaction.
Ryff Psychological Well-being Scales (RYFFPWB) - Changes in well-being Baseline, 12 weeks, 24 weeks Self-report measure of psychological well-being. Scores range from 14-84 for each subscale with higher scores indicating greater psychological well-being.
Modified Fatigue Impact Scale (MFIS) - Change in Fatigue Baseline, 12 weeks, 24 weeks Self-report measure of fatigue. Scores range from 0-84 with higher scores indicating greater fatigue.
MOS Pain Effects Scale (PES) - Change in Pain Baseline, 12 weeks, 24 weeks Self-report measure of pain. Scores range from 0-30 with higher scores indicating greater pain.
General Self-Efficacy Scale (GSES) - Change in Self-efficacy Baseline, 12 weeks, 24 weeks Self-report measure of self-efficacy. Scores range from 10-40 with higher scores indicating greater self-efficacy.
Trial Locations
- Locations (1)
Kessler Foundation
🇺🇸East Hanover, New Jersey, United States