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

NCT02030197 | Completed

• 1 other identifier: S14-00572
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• UCLA Revised Loneliness Scale

  Change from Baseline to week 12

• Chicago Multiscale Depression Inventory (CMDI)

  Change from Baseline to week 12

• Performance Scales (PS)

  Change from Baseline to week 12

• Community Integration Questionnaire (CIQ)

  Change from Baseline to week 12

Study Arms (2)

CRISP program

ACTIVE COMPARATOR

educational and socialization program

Behavioral: CRISP Program

Control Group

PLACEBO COMPARATOR

no treatment control group

Other: Control Group

Interventions

CRISP Program BEHAVIORAL

Educational program to improve self-efficacy, loneliness and depression

CRISP program

Control Group OTHER

no treatment

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU MS Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Manager

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 8, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (1)