Back to resultsImpact of CRISP on Self-Efficacy, Loneliness, and Depression (CRISP)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRISP Program
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
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.
Sites / Locations
- NYU MS Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
CRISP program
Control Group
Arm Description
educational and socialization program
no treatment control group
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02030197
Brief Title
Impact of CRISP on Self-Efficacy, Loneliness, and Depression
Acronym
CRISP
Official Title
Effects of an Educational Socialization Program Designed to Improve Self-Efficacy and Subsequent Effects on Decreasing Loneliness and Depression Among People With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Whether CRISP increases self-efficacy while decreasing loneliness and depression
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRISP program
Arm Type
Active Comparator
Arm Description
educational and socialization program
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
no treatment control group
Intervention Type
Behavioral
Intervention Name(s)
CRISP Program
Intervention Description
Educational program to improve self-efficacy, loneliness and depression
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
no treatment
Primary Outcome Measure Information:
Title
Multiple Sclerosis Self-Efficacy Scale (MSSS)
Description
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).
Time Frame
Change from Baseline to week 12
Secondary Outcome Measure Information:
Title
UCLA Revised Loneliness Scale
Description
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.
Time Frame
Change from Baseline to week 12
Title
Chicago Multiscale Depression Inventory (CMDI)
Description
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).
Time Frame
Change from Baseline to week 12
Title
Performance Scales (PS)
Description
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.
Time Frame
Change from Baseline to week 12
Title
Community Integration Questionnaire (CIQ)
Description
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.
Time Frame
Change from Baseline to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
NYU MS Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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Impact of CRISP on Self-Efficacy, Loneliness, and Depression
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