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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [boromukherji@gmail.com].

  6. 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.

  7. 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. 

 
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