Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000543785
Ethics application status
Approved
Date submitted
11/02/2022
Date registered
7/04/2022
Date last updated
13/03/2023
Date data sharing statement initially provided
7/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
MINDS-MS: Detection and treatment of depression in people with multiple sclerosis through neurology healthcare services
Scientific title
MINDS-MS: Detection and treatment of depression in people with multiple sclerosis through neurology healthcare services
Secondary ID [1] 306305 0
Sponsor: Monash University
PROTOCOL NUMBER: MINDS-MS01
Universal Trial Number (UTN)
Trial acronym
MINDS-MS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 325094 0
Depression 325095 0
Condition category
Condition code
Neurological 322518 322518 0 0
Multiple sclerosis
Mental Health 322519 322519 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Quantitative Survey and Clinical Interview

Rationale: Depression occurs in up to 50% of people living with Multiple Sclerosis (MS); 2-3 times higher than in the general population. Despite guidelines recommending screening for depression at each MS neurology review, and evidence for treatment efficacy, depression in MS remains under detected and undertreated. Studies have found reported rates of missed diagnosis to be around 23-30%, and up to 59% of patients with significant symptoms of depression not taking medication.
Given this, it is important to improve depressive symptom screening, monitoring and treatment practices in MS.

What: Patient-reported outcome measures will be administered via Qualtrics, a secure online data collection tool. There are four different surveys which will be distributed across the three parts. ValidSymp will also involve in person/telehealth clinician interview.

1. ValidQual
This part of the study will include two different online questionnaires via Qualtrics:

-People with MS depression: One custom questionnaire to quantify information identified from qualitative interviews assessing current practices and challenges faced in screening for and treating depression in people with MS. There are 48 questions in this survey, and it will take approximately 15 minutes to complete. This survey utilises the Depression Anxiety Stress Scales-21 (DASS-21)

-MS Clinicians: The questionnaire is a 53-item survey to be administered to MS clinicians in order to obtain a national understanding about the current barriers, required supports and other challenges in the detection and treatment of depression in MS through MS specialist healthcare settings. This includes demographic/clinician related questions, knowledge about depression in MS, current practice in screening and treatment of depression, barriers and facilitators and required support and training needs. It is expected to take 10-15 minutes to complete.Clinicians will be provided with a participant information sheet, and can select whether they would like to receive the results of the study.

2. Valid2QS, 15-20 minute survey ± 30 minute interview. Validation of a 2 question measure of depression in individuals with MS. Depression evaluation: Three depression screens will be administered, namely the 2 Question Screen (2QS), Depression Anxiety Stress Scales-21 (DASS-21) and Patient Health Questionnaire 9 (PHQ-9). The Structured Clinical Interview for DSM-5 (SCID) is a clinical interview that will be used to compare the screens against. A subgroup of participants with MS who complete the survey in the clinic (i.e., via the iPad; 15-20 minutes) will also complete the clinician administered SCID-5 (approximately 30 minutes) at the clinic. This survey and interview may also be administered via telehealth. To enable data collection for these studies, participants will be randomly assigned to nurse or neurologist administration of the 2QS (2-items). To minimise the possibility of bias, the SCID-5 administrator will be blinded to the results of the 2QS, DASS-21 and PHQ-9. Administration of the 2QS will be randomised across neurologist and nurse. It will also be administered to all participants via in-clinic iPad and online facilitated questionnaires, and assessed between groups for validity differences. Other screens will be administered via iPad or paper-based delivery at the same appointment the 2QS is administered.
Sensitivity and specificity of the 2QS to detect depression in people with MS will be calculated against clinical interview diagnosis for the subsample, and against the two depression screens for the entire sample. Clinical and online data will be analysed to identify any significant validation differences specific to administration setting.
Participants will additionally be administered questionnaires required for the VALIDSYMP study, which utilises the same sample.

3. ValidSymp, 15-20 minute survey. There will be two versions, one for individuals with MS and individuals without. The depressive symptom profile of all participants will be assessed using: The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress Anger – Short Form, Brief Irritability Test (BITe) and Difficulties in Emotion Regulation Scale (DERS-16) will be administered to characterise depressive symptom profile in people with and without MS.

Who provided: MS Clinicians must have more than 1-year experience in treating MS patients in Australia.

How:
All consented participants:
• Participant online questionnaires: Completed using Qualtrics data collection tool
• Clinic data collection via online input using an electronic device and Qualtrics data collection platform

Where: Online and MS clinics (Peninsula Health, Monash Health, The Talk Shop).

When and how much:

Study duration and critical time points: Quantitative recruitment for this study will run till the end of 2022.



Intervention code [1] 322751 0
Diagnosis / Prognosis
Comparator / control treatment
For one study, ValidSymp, we will be looking at Individuals without MS with depression and see whether their symptom profiles differ, this will be done by employing: The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress Anger – Short Form, Brief Irritability Test (BITe) and Difficulties in Emotion Regulation Scale (DERS-16). There is no comparator group for the other parts.
Control group
Active

Outcomes
Primary outcome [1] 330312 0
VALIDQUAL (Individuals with MS):
Outcomes of this custom made survey will be analysed descriptively for national generalisability. Measuring patient knowledge, current practices, barriers and facilitators of assessment and treatment of depression in MS.
Timepoint [1] 330312 0
Immediately at the time of enrolment
Primary outcome [2] 330571 0
VALIDSYMP: Characterise the depressive symptom profile for people with MS by comparing symptom expression through a composition of three different measures (the PROMIS Emotional Distress Anger – Short Form (5- items), the Brief Irritability Test (5-items) and the Difficulties in Emotional Regulation Scale (16-items) between people without MS.
Timepoint [2] 330571 0
Immediately at the time of enrolment
Primary outcome [3] 330572 0
VALID2Qs: Validate the sensitivity and specificity of the clinician delivered 2QS will be validated against the SCID-5 as the gold standard to detect depression in individuals with MS.
Timepoint [3] 330572 0
Immediately at the time of enrolment
Secondary outcome [1] 406725 0
PRIMARY OUTCOME

VALIDQUAL (MS CLINICIANS):
Outcomes of this custom made survey will be analysed descriptively for national generalisability. Measuring clinician knowledge, current practices, barriers and facilitators of assessment and treatment of depression in MS.
Timepoint [1] 406725 0
Immediately at the time of enrolment
Secondary outcome [2] 407563 0
PRIMARY OUTCOME

VALIDTAB:
Validate the sensitivity and specificity of the waiting room delivered PHQ-9 and DASS against the SCID-5 as the gold standard to detect depression in individuals with MS.
Timepoint [2] 407563 0
Immediately at the time of enrolment
Secondary outcome [3] 407564 0
To assess between-group differences in clinic administration and online administration between the 2QS.
Timepoint [3] 407564 0
Immediately at the time of enrolment
Secondary outcome [4] 408302 0
To assess between-group differences in clinic administration and online administration between the DASS.
Timepoint [4] 408302 0
Immediately at the time of enrolment
Secondary outcome [5] 408303 0
To assess between-group differences in clinic administration and online administration between the PHQ-9.
Timepoint [5] 408303 0
Immediately at time of enrolment

Eligibility
Key inclusion criteria
All of the following criteria must be satisfied for enrolment in the study:

MS clinicians
1. Provides healthcare services to people with MS (does not need to be their main or only patient population)
2. Access to an internet connection and computer facilities, required to complete online survey

People with MS
1. 18 years or older
2. A self-reported confirmed diagnosis of multiple sclerosis (any subtype)
3. Able to read and write in English language
4. Access to an internet connection and computer facilities, required to complete assessments, for online recruitment

People without MS
1. 18 years or older
2. Able to read and write in English language
3. Access to an internet connection and computer facilities, required to complete assessments
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of any of the following criteria will exclude the participant from enrolment in the study.

People with MS and people without MS
1. Severe cognitive dysfunction deemed to interfere with the person’s ability to undertake study requirements. As determined by:
a. the MS clinic team (neurologist; MS nurse) for clinic participation;
b. the inability to participate in online assessments (implied).

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
VALID QUAL: Sample size for ValidQual has been set at 300 people with MS and 50 clinicians. Given the aim of the ValidQual study is to validate the views gained from qualitative interview data, this sample size has been determined to ensure views are representative of people with MS and clinicians across Australia, rather than for statistical analysis requirements.

VALIDSYMP: Cluster analysis and factor analysis/principal components analysis will be used to characterise the depressive symptom profile in MS when compared with people without MS. A sample size >150 is adequate for analysis of these techniques.

VALID2QS: Sensitivity and specificity analysis will be used to validate the 2QS against the two other depression screens and clinical interview. Power analysis has been undertaken to confirm recruitment numbers to detect differences in validity across 3 x administration groups (neurologist, nurse, iPad) using ANCOVA, requiring: N=196 using alpha=.05, power=.80, medium effect size. Thus, sample size is adequate for analysis that will be undertaken. Statistical assessment will be undertaken primarily using SPSS.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/03/2022
Date of last participant enrolment
Anticipated
4/03/2024
Actual
Date of last data collection
Anticipated
8/07/2024
Actual
Sample size
Target
725
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 21610 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 21830 0
Frankston Hospital - Frankston
Recruitment hospital [3] 21869 0
Frankston Neurology - Frankston
Recruitment hospital [4] 21870 0
The Talk Shop - Wheelers Hill
Recruitment postcode(s) [1] 36934 0
3150 - Wheelers Hill
Recruitment postcode(s) [2] 36536 0
3168 - Clayton
Recruitment postcode(s) [3] 36888 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 310675 0
Charities/Societies/Foundations
Name [1] 310675 0
MS Research Australia (now MS Australia)
Country [1] 310675 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash Medical Centre, Level 7 TRF Building, 246 Clayton Road, Clayton, VIC, 3168.
Country
Australia
Secondary sponsor category [1] 312125 0
None
Name [1] 312125 0
Address [1] 312125 0
Country [1] 312125 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310246 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 310246 0
Research Support Services Monash Health
Level 2, I Block
Monash Medical Centre 246 Clayton Road
Clayton Victoria 3168
Ethics committee country [1] 310246 0
Australia
Date submitted for ethics approval [1] 310246 0
12/11/2021
Approval date [1] 310246 0
10/02/2022
Ethics approval number [1] 310246 0
RES-21-0000-740A

Summary
Brief summary
This research has direct translational value for people with MS, critical given the impact of depression on people with MS. Outcomes are aimed at supporting clinicians to improve detection and management of depression in people with MS through neurology services. It will provide recommendations and supports to improve detection and treatment and will enable submission of funding proposals to facilitate the next translational phase (years 4-5) through iterative feasibility and acceptability implementation across neurology settings, ensuring suitability for rollout.

Results will: 1) fill a knowledge gap about barriers and required supports to improve assessment and treatment in Australian neurology practices, 2) provide Australian validation data to screen for depression in routine clinical practice; 3) characterise the depressive symptom profile in MS to identify whether it differs in presentation from depression in people without MS requiring specific patient and clinician education; 4) utilise this research, literature review and advisory committee expertise to develop recommendations and supports that improve detection, treatment and monitoring of depression in people with MS.

It will result in high-quality peer review journal outputs and conference presentation outputs reporting each sub- study, as well as a report detailing overall program results that will be submitted to relevant MS healthcare, consumer, advocacy and research organisations. This research has potential to positively impact people with MS who experience depression, and their families, as well as to provide economic gains by reducing direct and indirect costs of the impact of depression on MS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116990 0
Dr Lisa Grech
Address 116990 0
Monash Medical Centre, Level 7 TRF Building, 246 Clayton Road, Clayton, VIC, 3168.
Country 116990 0
Australia
Phone 116990 0
+61 410947444
Fax 116990 0
Email 116990 0
lisa.grech@monash.edu
Contact person for public queries
Name 116991 0
Dr Lisa Grech
Address 116991 0
Monash Medical Centre, Level 7 TRF Building, 246 Clayton Road, Clayton, VIC, 3168.
Country 116991 0
Australia
Phone 116991 0
+61 410947444
Fax 116991 0
Email 116991 0
lisa.grech@monash.edu
Contact person for scientific queries
Name 116992 0
Dr Lisa Grech
Address 116992 0
Monash Medical Centre, Level 7 TRF Building, 246 Clayton Road, Clayton, VIC, 3168.
Country 116992 0
Australia
Phone 116992 0
+61 410947444
Fax 116992 0
Email 116992 0
lisa.grech@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.