Multiple SclerosisCRISPNCT02030197
Impact of CRISP on Self-Efficacy, Loneliness, and Depression
A study testing CRISP Program in people with Multiple Sclerosis, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- CRISP Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Whether CRISP increases self-efficacy while decreasing loneliness and depression
- Conditions
- Multiple Sclerosis
- Being tested
- CRISP Program, Control Group
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRISP ProgramBehavioural
Educational program to improve self-efficacy, loneliness and depression
Control GroupOther
no treatment
| Study group | Role | What they receive |
|---|---|---|
| CRISP program | Active comparator | educational and socialization program Receives: Behavioral: CRISP Program |
| Control Group | Placebo comparator | no treatment control group Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from Baseline to week 12
Secondary outcomes (4)
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.
Measured: Change from Baseline to week 12
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).
Measured: Change from Baseline to week 12
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.
Measured: Change from Baseline to week 12
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.
Measured: Change from Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Tamar Kalina, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030197
- Sponsor's protocol ID
- S14-00572
- Acronym
- CRISP
- Status last verified
- Dec 2014
- First submitted
- 6 Jan 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02030197
- Acronym / sponsor ID
- CRISP / S14-00572
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRISP program | Active comparator | Behavioral: CRISP Programeducational and socialization program |
| Control Group | Placebo comparator | Other: Control Groupno treatment control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRISP ProgramEducational program to improve self-efficacy, loneliness and depression | Behavioural | CRISP program |
| Control Groupno treatment | Other | Control Group |
Primary outcome
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).
4 secondary outcomes
UCLA Revised Loneliness Scale
Time frame: Change from Baseline to week 12
Chicago Multiscale Depression Inventory (CMDI)
Time frame: Change from Baseline to week 12
Performance Scales (PS)
Time frame: Change from Baseline to week 12
Community Integration Questionnaire (CIQ)
Time frame: Change from Baseline to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRISP Program in people with Multiple Sclerosis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Sclerosis Self-Efficacy Scale (MSSS) (time frame: Change from Baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.