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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unified Protocol intervention | Experimental | 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. |
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| Control group | No Intervention | The control group will not receive any intervention and will complete the same baseline and follow-up assessments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unified Protocol | Behavioral | The Unified Protocol is a transdiagnostic intervention developed to treat depression and anxiety. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Belinda L Washington, BA | Contact | 973-324-8446 | bwashington@kesslerfoundation.org | |
| Lauren B Strober, PhD | Contact | 973-324-8459 | lstrober@kesslerfoundation.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | Recruiting | East Hanover | New Jersey | 07936 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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The assessor is blinded to the group assignment
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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |