| CTRI Number |
CTRI/2024/05/067372 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Improving Memory to Improve Mood: A Study on Memory Training in Depression |
|
Scientific Title of Study
|
Feasibility and Effectiveness of Memory Specificity Training MeST in Individuals with Depressive Disorder An Open Label pre post comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Rashmi Pandey |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of Behavioral health and allied sciences (AIBHAS) Amity University Noida |
| Address |
J-1 Block 2nd Floor Room 213 Department of Amity Institute of Behavioural health and allied sciences (AIBHAS) Clinical Psychology Division Amity University Sector 125 Gautam Budhha Nagar Noida
Gautam Buddha Nagar UTTAR PRADESH 201313 India |
| Phone |
9871167455 |
| Fax |
|
| Email |
rpandey@amity.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Rashmi Pandey |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of Behavioral health and allied sciences (AIBHAS) Amity University Noida |
| Address |
J-1 Block 2nd Floor Room 213 Department of Amity Institute of Behavioural health and allied sciences (AIBHAS) Clinical Psychology Division Amity University sector 125 Gautam Budhha Nagar Noida
Gautam Buddha Nagar UTTAR PRADESH 201313 India |
| Phone |
9871167455 |
| Fax |
|
| Email |
rpandey@amity.edu |
|
Details of Contact Person Public Query
|
| Name |
Ms. Bornali Mukherji |
| Designation |
M.Phil Clinical Psychology Trainee |
| Affiliation |
Amity Institute of Behavioral health and allied sciences (AIBHAS) Amity University Noida |
| Address |
J-1 Block 2nd Floor Room 212 Department of Amity Institute of Behavioural health and allied sciences (AIBHAS) Clinical Psychology Division Amity University Sector 125 Gautam Budhha Nagar Noida
Gautam Buddha Nagar UTTAR PRADESH 201313 India |
| Phone |
8826003743 |
| Fax |
|
| Email |
boromukherji@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amity Institute of Behavioural Health and Allied sciences (AIBHAS) J-1 Block 2nd Floor Room 212 Clinical Psychology Division Amity University AUUP gautam buddha nagar sector 125 noida uttar pradesh 201313 |
|
|
Primary Sponsor
|
| Name |
Bornali Mukherji |
| Address |
J-1 Block 2nd Floor Room 212 Department of Amity Institute of Behavioural health and allied sciences (AIBHAS) Clinical Psychology Division Amity University Sector 125 Gautam Budhha Nagar Noida Uttar Pradesh-201313 India |
| 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 |
| Dr Rashmi Pandey |
Amity Institute of Behavioural Health and Allied Sciences (AIBHAS) Amity University Noida |
J-1 Block 2nd Floor Room 213 Department of Amity Institute of Behavioural health and allied sciences (AIBHAS) Clinical Psychology Division Amity University sector 125 Gautam Budhha Nagar Noida Gautam Buddha Nagar UTTAR PRADESH |
9871167455
rpandey@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amity University Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Memory Specificity Training (MeST) |
Intervention Structure
1. Total number of sessions - 4
2. Duration of each session - 50-60 minutes
3. Mode - Offline, Individual
4. Total duration of intervention- 2 weeks
5. Dose of intervention - 2 sessions per week
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of Depressive episode (F32.0-F32.1) and Recurrent Depressive Disorder (F33.0- F33.1) according to International Classification of Diseases – Diagnostic Criteria for Research (DCR) – Tenth Edition (ICD –10, DCR., World Health Organisation, 1993).
2. Patients with a score of 10-18 (mild-to-moderate depression) on Beck Depression Inventory (BDI; Beck et al., 1961).
3. Level of memory specificity being lower than 70% as assessed on the Autobiographical Memory Test (AMT; Williams & Broadbent, 1986).
4. Patients aged between 18-50 years.
5. Educated up to 10th grade.
6. Patients that are fluent in English.
7. Individuals who are a right-handed. |
|
| ExclusionCriteria |
| Details |
1. High levels of suicide intent (ascertained from clinical interview and clinical judgement).
2. Current symptoms of psychosis
3. BDI score of severe depression having high suicidal intent.
4. Currently receiving treatment for depression other than anti-depressant medications that have been stable in type and dosage for at least a duration of 4 weeks.
5. Presence of intellectual disability or traumatic brain injury.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in subjective and objective depressive symptoms, memory specificity. |
3 time point: Baseline measurements, Post-intervention, and 1 month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| rumination, and mindfulness |
3 time points: Baseline measures, post intervention, 1 month followup |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
01/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [boromukherji@gmail.com].
- For how long will this data be available start date provided 20-05-2025 and end date provided 20-05-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Depression affects about 280 million people worldwide and in low-income countries like India with limited skilled clinicians, resources, and high waiting time; efficient treatment options are imperative. CaR-FA-X model suggests, individuals with recurrent depressive disorders have disturbances in autobiographical memory, specifically the propensity to recollect over generalised autobiographical memory (OGM). It functions as an avoidance strategy abating the undesirable impact of recalling specific memories containing emotionally distressing themes. Overgeneralised negative self-judgements seize the retrieval of specific memory contributing to worthlessness and hopelessness while inability to recall specific memories of positive experiences exacerbates anhedonia and reduces ability to repair low mood, playing a significant role in maintenance and relapse of depression. In the present research, MEmory Specificity Training (MeST) will target the reduction of OGM by training autobiographical memory specificity to improve depressive symptomology. Aim of the study is to assess the effectiveness of MeST in depression. Methods to be used will be a pre-post intervention study, 40 individuals with major depressive disorder as per ICD-10 DCR will be recruited from clinical settings using purposive sampling method. After baseline assessments of memory specificity, depression, rumination and mindfulness, participants will alternatively be allocated into MeST + Pharmacotherapy group and Pharmacotherapy only group. MeST group will receive 4 bi-weekly sessions of 60 minutes and participants would be assessed at post-intervention along with both groups being assessed at 1 month follow up as well. This intervention study will help in investigating the feasibility and acceptability of MeST in Indian context and future research may guide whether this can be used as a stand alone or adjunct therapy to other gold standard therapies that fail to address autobiographical memory deficits. |