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

NCT ID: NCT02030197

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-12-31

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

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CRISP program

educational and socialization program

Group Type ACTIVE_COMPARATOR

CRISP Program

Intervention Type BEHAVIORAL

Educational program to improve self-efficacy, loneliness and depression

Control Group

no treatment control group

Group Type PLACEBO_COMPARATOR

Control Group

Intervention Type OTHER

no treatment

Interventions

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CRISP Program

Educational program to improve self-efficacy, loneliness and depression

Intervention Type BEHAVIORAL

Control Group

no treatment

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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J. Tamar Kalina

Program Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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NYU MS Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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S14-00572

Identifier Type: -

Identifier Source: org_study_id