| CTRI Number |
CTRI/2018/07/015090 [Registered on: 27/07/2018] Trial Registered Prospectively |
| Last Modified On: |
24/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to assess the effects of multimodal stress management programme on selected clinical and psychosocial parameters of People living with HIV/AIDS. |
|
Scientific Title of Study
|
Effectiveness of multimodal stress management programme on symptoms experience, medication adherence, CD4 count and selected psychosocial parameters of People living with HIV/AIDS" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shriharsha C |
| Designation |
Associate Professor and HOD, |
| Affiliation |
BVVS Sajjalashree Institute of Nursing Sciences |
| Address |
Department of Psychiatric Nursing, Room No.5,
BVVS Sajjalashree Institute of Nursing Sciences, Navanagar, Bagalkot,
Karnataka
Navanagar, Bagalkot - 587102
Karnataka
Bagalkot
KARNATAKA
587102
India |
| Phone |
9845777592 |
| Fax |
08354235257 |
| Email |
harsha592@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Sreevani |
| Designation |
Professor and HOD |
| Affiliation |
Dharwad Institute of Mental Health and Neuro Sciences |
| Address |
Department of Psychiatric Nursing,Academic Block, Dharwad Institute of Mental Health and Neuro Sciences, Belagavi Road,Dharwad, Karnataka
Dharwad Institute of Mental Health and Neuro Sciences, Belagavi Road,Dharwad, Karnataka
Dharwad
KARNATAKA
580008
India |
| Phone |
9880778933 |
| Fax |
|
| Email |
sreevani.phd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shriharsha C |
| Designation |
Associate Professor |
| Affiliation |
BVVS Sajjalashree Institute of Nursing Sciences |
| Address |
Department of Psychiatric Nursing, Room No.5,
BVVS Sajjalashree Institute of Nursing Sciences, Navanagar, Bagalkot,
Karnataka
Navanagar, Bagalkot - 587102
Karnataka
Bagalkot
KARNATAKA
587102
India |
| Phone |
9845777592 |
| Fax |
08354235257 |
| Email |
harsha592@gmail.com |
|
|
Source of Monetary or Material Support
|
| ART Centre of Bagalkot, A unit of Karnataka State AIDS Prevention Society, Bangalore |
|
|
Primary Sponsor
|
| Name |
BVVS Sajjalashree Institute of Nursing Sciences |
| Address |
Navanagar, Bagalkot - 587102 Karnataka |
| Type of Sponsor |
Other [Private Nursing College] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shankar B Shindhe |
District Government Hospital |
ART Plus Centre,
Room No.3
Navanagar, Bagalkot - 587102 Karnataka
Bagalkot
KARNATAKA |
9964177635
shankarbshindhe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SIONS- Institutional Ethics Committee on Human Subjects Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Symptom Experience
Medication Adherence
CD4 Count
Depression
Anxiety
Quality of Life, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive behavioural based multimodal stress management programme |
It is a multi-component stress management group intervention that takes into account patient’s physical and psychosocial needs. In the present study the MSMP is a multi-component group approach based on Cognitive Behavioural Therapy integrated with motivational interviewing with psychotherapeutic techniques like Psycho-education, Group dynamic exercises, Homework, Cognitive strategies, Behavioural strategies, problem solving skill training, social skill training which fulfil PLHIV’s physical and psychosocial needs.
|
| Comparator Agent |
Treatment as usual |
Control group subjects will be on routine treatment provided at ART centre |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Who are with current diagnosis of HIV/AIDS
Who are aged between 18-60 years
Who are able to read and write Kannada/ English
Who are on ART
Whose CD4 count has been done during last one month
Who are coming for regular follow ups during last 3 months
|
|
| ExclusionCriteria |
| Details |
Who are suffering from severe illness and unable to provide data
Who are already on any other psychotherapy
Who have history of drug abuse or alcohol dependence within the last 3 months
Major depression
Who are not on ART within last 3 months
Whose CD4 count less than 100 cells/mm3 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WHO QOL HIV Bref Score |
Baseline, First, Second, Third and 6th Post Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptom experience score, Medication adherence score, CD4 count, CES-D Depression Score, GAD-7 Anxiety Score |
Baseline, First, Second, Third and 6th Post Intervention. CD4 count will be taken from Hospital Records at Base line and 6th month Post Intervention |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2018 |
| 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="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Non Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, controlled, parallel group trial comparing the effects of multimodal stress mangement programme and treatment as usual for one month with 100 People living with HIV/AIDS at ART Centre, Bagalkot, Karnataka, India. The primary outcomes will be symptom experience, medication adherence, CES-D Depression Score, GAD-7 Anxiety Score, WHOQOL HIV Bref Score at first, second, third and 6th month post intervention and CD4 count at 6th month post intervention. |