| CTRI Number |
CTRI/2022/01/039258 [Registered on: 07/01/2022] Trial Registered Prospectively |
| Last Modified On: |
06/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Psychological therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A psychological Therapy for Hallucination |
|
Scientific Title of Study
|
Development of Manualized Metacognitive Therapy for Hallucination |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devvarta Kumar |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, MV Govindaswamy building, Room no 304, NIMHANS, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995188 |
| Fax |
|
| Email |
devvarta.k@nimhans.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Devvarta Kumar |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, MV Govindaswamy building, Room no 304, NIMHANS, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995188 |
| Fax |
|
| Email |
devvarta.k@nimhans.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Devvarta Kumar |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, MV Govindaswamy building, Room no 304, NIMHANS, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995188 |
| Fax |
|
| Email |
devvarta.k@nimhans.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Devvarta Kumar |
| Address |
Department of Clinical Psychology, MV Govindaswamy building, Room no 304, NIMHANS, Bangalore |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Devvarta Kumar |
National Institute of Mental Health and Neurosciences |
NIMHANS, Hosur road, Bangalore-560029
Bangalore
KARNATAKA |
08026995188
devvarta.k@nimhans.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, NIMHANS, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F200||Paranoid schizophrenia, (2) ICD-10 Condition: F203||Undifferentiated schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metacognitive Therapy for hallucination plus treatment as usual. |
The primary focus of therapy will be promoting metacognitive insight into the phenomenology of hallucinations and their cognitive and biological underpinnings in patients (with schizophrenia) experiencing hallucination. It will be followed by helping patients to relate the learning with their hallucinatory experiences. The whole module will be of 9 sessions of 45-60 minutes (apart from the sessions on rapport establishment and assessment). Also, this group will continue receiving Treatment as Usual which will consist of psychopharmacological management and any other routine care (such as psychoeducation which is routinely done for any patient with schizophrenia focusing on need for medication compliance, activity scheduling and so on). Further, the experimental group will also undergo three-points assessment, i.e., baseline, post-intervention (after completion of intervention which will take approximately 5 weeks), and 4 weeks after the 2nd assessment. The assessment will focus on assessing symptom severity, insight into hallucination, cognitive functions etc. |
| Comparator Agent |
treatment as usual for the control group |
The wait-list control group will receive Treatment as Usual which will consist of psychopharmacological management and any other routine care (such as psychoeducation which is routinely done for any patient with schizophrenia focusing on need for medication compliance, activity scheduling and so on).
Similar to the experimental group, the control group will also undergo three-points assessment (baseline, 5 weeks after the baseline assessment, and 4 weeks after the 2nd assessment). The assessment will focus on symptom severity, insight into hallucination, cognitive functions etc.
Once the three-points assessments (pre-, post-, and follow-up) are over, the participants in this group will also be given the option to undergo metacognitive therapy for hallucination (given to the intervention group). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis of paranoid or undifferentiated schizophrenia
2.Age between 18-50 years
3.Education, at least, at primary level
4.Conversant in Hindi and/or English
|
|
| ExclusionCriteria |
| Details |
• Presence of Formal Thought Disorder
• ECT in past 1 month
• Alcohol or substance dependence
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the severity of and insight into the hallucinatory experiences of patients with schizophrenia experiencing hallucination |
Base-line, 5 weeks after baseline assessment (post-intervention), 9 weeks after baseline assessment (Follow-up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Global assessment of functioning |
Base-line, 5 weeks after baseline assessment (post-intervention), 9 weeks after baseline assessment (Follow-up) |
| Severity of positive and negative symptoms |
Base-line, 5 weeks after baseline assessment (post-intervention), 9 weeks after baseline assessment (Follow-up) |
| Perceived sense of recovery |
Base-line, 5 weeks after baseline assessment (post-intervention), 9 weeks after baseline assessment (Follow-up) |
| Cognitive functions |
The assessment will be done at baseline only |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/01/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is intended to develop a metacognitive intervention to assist individuals diagnosed with schizophrenia to have better insight into the hallucinatory experiences. The primary focus of therapy will be promoting metacognitive insight into the phenomenology of hallucinations and their cognitive and biological underpinnings. It will be followed by helping patients to relate the learning with their hallucinatory experiences. The whole module will be of 9 sessions of 45-60 minutes |