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

Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030197
• Other study ID #: S14-00572
• Status: Completed
• Phase: N/A
• First received: January 6, 2014
• Last updated: December 1, 2014
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Whether CRISP increases self-efficacy while decreasing loneliness and depression

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• CRISP Program
Educational program to improve self-efficacy, loneliness and depression

Other:
• Control Group
no treatment

Locations

Country	Name	City	State
United States	NYU MS Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No