Impact of CRISP on Self-Efficacy, Loneliness, and Depression

Study Overview
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Brief Summary
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The purpose of this study is to examine the effects of an innovative program, entitled CRISP (Community Integration for Socially Isolated Patients), on improving self-efficacy and assessing whether improved self-efficacy helps to reduce depression and loneliness of people with MS.

Detailed Description
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Whether CRISP increases self-efficacy while decreasing loneliness and depression

Official Title
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Effects of an Educational Socialization Program Designed to Improve Self-Efficacy and Subsequent Effects on Decreasing Loneliness and Depression Among People With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: CRISP Program
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 65 years old. Must have a definitive diagnosis of MS by a physician. Must understand English at 6th grade level since the CRISP program requires participants to comprehend the educational information presented in English. Agree to participate in 12 group sessions over 12 weeks; Must have the ability to complete questionnaires in English since the outcome measures used for the study are in English. Must be able to commute to the site destinations Exclusion Criteria: Have an actively psychotic Axis I disorder. Have a significant Axis II disorder of borderline personality disorder or schizoid personality disorder. Have a diagnosis of another neurological condition aside from MS. Inability to comply with study requirements/visits.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: CRISP program<br>educational and socialization program | Behavioral: CRISP Program<br>* Educational program to improve self-efficacy, loneliness and depression<br>|
| Placebo Comparator: Control Group<br>no treatment control group | Other: Control Group<br>* no treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple Sclerosis Self-Efficacy Scale (MSSS) | The Multiple Sclerosis Self-Efficacy Scale (MSSS) is designed to measure self-efficacy in people diagnosed with MS. The MSSS incorporates aspects of social interaction and themes related to beliefs of control over future events, which is based on Bandura's definition of self-efficacy (Rigby et al., 2003). The MSSS is a 14 item, six-point Likert scale and participants are asked to rate their level of agreement or disagreement for each item on the scale ranging from 'strongly disagree' (1) to 'strongly agree' (6). Examples of questions include sometimes I feel embarrassed in public places or I have as much independence as I need. Scores can range from 14 (low self-efficacy) to 84 (high self-efficacy). | Change from Baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UCLA Revised Loneliness Scale | The UCLA Revised Loneliness Scale was developed to assess subjective feelings of loneliness and is widely used in loneliness research. The scale consists of 20 questions about loneliness asking participants to rate each question from 1 (never) to 4 (always), higher scores indicating greater degrees of loneliness. | Change from Baseline to week 12 | 
| Chicago Multiscale Depression Inventory (CMDI) | The Chicago Multiscale Depression Inventory will be used to assess symptoms of depression. The CMDI is a 50-item self-report measure that includes three subscales representing different types of depression symptoms: vegetative, mood, and evaluative. Each item on the scale consists of a single word or brief phrase describing feelings or experiences and participants rate each item on a Likert scale from 1 (not at all) to 5 (extremely). | Change from Baseline to week 12 | 
| Performance Scales (PS) | The Performance Scales (PS) is a self-reported measure of MS disease status assessing mobility, hand function, vision, fatigue, cognitive symptoms, bladder/bowel, sensory symptoms, spasticity, pain, depression, and tremor/coordination. Each scale of the PS (with the exception of the mobility scale) is a 6 item ordinal scale and participants are asked to describe their functioning in each area as compared to before they developed MS. Scores range from normal (0) to total disability in specified area (5) with higher scores indicating greater perceived disability. The mobility scale has a range from normal (0) to total gait disability or bedridden (6) and asks participants to choose the category that describes their walking ability in the past four weeks. | Change from Baseline to week 12 | 
| Community Integration Questionnaire (CIQ) | The Community Integration Questionnaire (CIQ) was developed to assess community integration after an injury with questions about home integration, social integration and productive activities. The CIQ is a 15 item self-report measure. The basis for scoring is by the frequency of performing specific activities and providing subtotals for each category of community integration as well as an overall score. | Change from Baseline to week 12 |