| CTRI Number |
CTRI/2024/05/066753 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Psychological Intervention
for Persons with Multiple Sclerosis |
|
Scientific Title of Study
|
A Multimodal Psychological Intervention
for Persons with Multiple Sclerosis:
Development, Feasibility, and Efficacy Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sindhura Lakshmikanth |
| Designation |
PhD Scholar |
| Affiliation |
University - National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, NIMHANS, Hosur Road, Bangalore, India
Bangalore
KARNATAKA
560029
India |
| Phone |
9663702782 |
| Fax |
|
| Email |
sindhura216@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Paulomi M Sudhir |
| Designation |
Professor |
| Affiliation |
University - National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, NIMHANS, Hosur Road, Bangalore, India
Bangalore
KARNATAKA
560029
India |
| Phone |
9886176879 |
| Fax |
|
| Email |
paulomi.sudhir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Paulomi M Sudhir |
| Designation |
Professor |
| Affiliation |
University - National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, NIMHANS, Hosur Road, Bangalore, India
Bangalore
KARNATAKA
560029
India |
| Phone |
9886176879 |
| Fax |
|
| Email |
paulomi.sudhir@gmail.com |
|
|
Source of Monetary or Material Support
|
| UGC - Senior Research Fellowship
(the study is being conducted at the National Institute of Mental Health and Neurosciences) |
|
|
Primary Sponsor
|
| Name |
Government University Grants Commission UGC |
| Address |
Bahadur Shah Zafar Marg ITO Metro Gate Number 3, Road, Delhi, 110002 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| No secondary sponsor |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sindhura Lakshmikanth |
National Institute of Mental Health and Neuro Sciences |
Department of Clinical Psychology, 3rd Floor, Dr M V Govindaswamy Building, NIMHANS, Hosur Road, Bangalore-560029
Bangalore
KARNATAKA |
9663702782
sindhura216@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Ethics Committee - Behavioral Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G35||Multiple sclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A Multimodal Psychological Intervention for Persons with Multiple Sclerosis |
The intervention will comprise of psychotherapy modules to target mood, illness perceptions and adaptation to illness. It will have modules that incorporate psychological techniques to address regulation of mood, problem solving, illness perceptions, management of pain and fatigue. |
| Comparator Agent |
Treatment As Usual |
Standard clinical care and medical treatment by neurologists at NIMHANS. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A clinician made diagnosis of Relapsing-Remitting Multiple Sclerosis diagnosis
based on the Modified McDonald’s criteria of duration less than 5 years, or with an EDSS
score less than 5 if the duration is greater than 5 years.
Working knowledge of English and, or Tamil. |
|
| ExclusionCriteria |
| Details |
Other MS subtypes, apart from RRMS.
Clinically relevant cognitive deficits as evaluated by the treating neurologist and
indicated by a score of less than 25 on the HMSE.
H/o of severe psychiatric disorders, such as psychosis, severe depression, with
suicidality, or any other psychiatric disorder that prevents patient from participating in
the study and/or requires clinical priority.
Clinically relevant physical impairments, defined as an Expanded Disability Status
Scale (EDSS) score higher than 5. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety and Depression |
Pre-intervention, post-intervention, 3-month follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life, Illness Perceptions, Resilience, Self-efficacy |
Pre-intervention, post-intervention, 3-month follow-up |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be a parallel two-arm randomized, controlled trial with an intervention group and a treatment-as-usual group, with baseline, post-treatment and 3-month follow-up assessment. The subjects will be randomized using computer-generated random number tables with allocation concealment. Primary outcome measures will be assessed by an independent blinded rater at baseline, post, and 3-month follow-up points. A sample of 44 patients with a diagnosis of MS will be recruited from NIMHANS outpatient clinical services. Individuals who meet inclusion criteria and give consent will be recruited for the study. They will be assigned to the intervention or treatment as usual group using block randomization. The participants of both the groups will complete the baseline assessment which will include the socio-demographic data form and the outcome measures. The outcome measures will be administered by an independent assessor who is blinded to the groups. The intervention group will receive the psychotherapy intervention. The primary and secondary outcome measures will be administered post-intervention and 3-month follow-up to both the groups by an independent blinded rater. |