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OpenTrials
Completed

NCT Number: NCT02030197

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU MS Center

New York, 10016, United States

About this study

Whether CRISP increases self-efficacy while decreasing loneliness and depression

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CRISP Program

Behavioral

Educational program to improve self-efficacy, loneliness and depression

Control Group

Other

no treatment

Primary outcomes

  1. Multiple Sclerosis Self-Efficacy Scale (MSSS)

    Time frame: Change from Baseline to week 12

    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 outcomes

  1. UCLA Revised Loneliness Scale

    Time frame: Change from Baseline to week 12

    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.

  2. Chicago Multiscale Depression Inventory (CMDI)

    Time frame: Change from Baseline to week 12

    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).

  3. Performance Scales (PS)

    Time frame: Change from Baseline to week 12

    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.

  4. Community Integration Questionnaire (CIQ)

    Time frame: Change from Baseline to week 12

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study 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

Acronym: CRISP

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 8, 2014
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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