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CTRI Number  CTRI/2024/07/070358 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 27/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to test the effect of emotion regulation based intervention in patients with depression 
Scientific Title of Study   Efficacy of Unified Protocol for Depression: A Randomized Controlled 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  Kezia Iris Christopher 
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Department of Clinical Psychology, 3rd Floor, Dr. M. V. Govindaswamy Building Hosur Road

Bangalore
KARNATAKA
560029
India 
Phone  9884670983  
Fax    
Email  keziachristopher@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjula M 
Designation  Professor 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Department of Clinical Psychology, 3rd Floor, Dr. M. V. Govindaswamy Building Hosur Road

Bangalore
KARNATAKA
560029
India 
Phone  9632603597  
Fax    
Email  drmanjula71@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kezia Iris Christopher 
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Department of Clinical Psychology, 3rd Floor, Dr. M. V. Govindaswamy Building Hosur Road

Bangalore
KARNATAKA
560029
India 
Phone  9884670983  
Fax    
Email  keziachristopher@gmail.com  
 
Source of Monetary or Material Support  
University Grants Commission- National Eligibility Test Junior Research Fellowship 
 
Primary Sponsor  
Name  Kezia Iris Christopher 
Address  Department of Clinical Psychology, NIMHANS, Hosur Road, Bengaluru 560029 
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 Manjula M  National Institute of Mental Health and Neurosciences  Department of Clinical Psychology, Dr M.V. Govindaswamy Building, NIMHANS, Hosur Road, Benagaluru 560029
Bangalore
KARNATAKA 
9632603597

drmanjula71@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee (Behavioural Sciences Division)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Treatment as Usual (TaU)  Refers to the standard, routine care that is accessible to patients. In this study, it refers to the pharmacological and unstructured therapy that is offered as a part of outpatient and inpatient services. 
Intervention  Unified Protocol for Transdiagnostic Treatment of Emotional Disorders  It is an empirical, emotion-focussed cognitive-behavioural therapy which focusses on changing core emotional processes through core skills such as mindful awareness, re-evaluation of automatic cognitive appraisals, alteration of behaviours linked to dysregulated emotions and utilization of exposure. It is a manualized, evidence-based 12-15 session protocol that consists of 5 core modules and 3 additional modules. The therapy would ideally be weekly sessions of 1-1.5 hours duration. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Individuals with a principle diagnosis of moderate to severe depression, single episode and recurrent according to the DSM V criteria with or without other comorbid Axis I diagnosis or Axis II traits as assessed and screened by DIAMOND and SCID-V PD.
2. Patients who are fluent and conversant in English or Tamil, with an ability to read English.
3. Patients whose symptoms are stabilized with medication for at least 4 weeks.
4. Patients willing to commit to 3-4 months of therapy. 
 
ExclusionCriteria 
Details  1. Patients with other Axis I or II primary diagnosis, other neurological, neurodevelopmental disorders or any other organic cause that can affect engagement in therapy.
2. Individuals having depression with psychotic symptoms.
3. Patients who have substance use disorder, with immediate need for detox.
4. Patients who are already in therapy and have had over 5 sessions in the past 3 months.
5. Patients with high suicidality or those whose symptoms interfere in the therapy process as assessed clinically during intake or screening.
6. Women who are pregnant or meet criteria for post-partum depression.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Severity in Depression Scores  Baseline
Post Intervention
3-month followup 
 
Secondary Outcome  
Outcome  TimePoints 
Severity of Anxiety
Severity of Depression(Self-report)
Emotion Regulation
Distress Tolerance
Experiential Avoidance
Affect
Beliefs
Cognitive Flexibility
Working Alliance 
Baseline
Mid-Intervention
Post Intervention
3-month Followup 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/08/2024 
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="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Depression is a chronic and incapacitating mental health condition that is characterised by experience and poor regulation of low-mood, increased fatigue, feelings of guilt, worthlessness, helplessness, hopelessness, decreased appetite and sleep disturbances. With a global prevalence rate of 7% (Brody et al., 2018), depression is considered as a top contributor to global disability (WHO, 2017). Cognitive-behavioural therapy is considered to be the ‘gold- standard’ treatment amongst psychological interventions for treating depressive symptoms, however it takes a cross-sectional approach in treating the negative cognitions and associated changes in behaviours and emotions. With depression having one of the highest recurrence rate of 60%, the need to address underlying processes takes precedence. The Unified Protocol is a trans-diagnostics, emotion-focussed cognitive-behavioural therapy that incorporates several relevant cognitive-behavioural concepts to address the processes such as emotion-regulation strategies, experiential avoidance and poor distress tolerance that precipitate and maintain depressive episodes and further cause increased relapse rates. It further helps address the multitudes of comorbidities that depression manifests with such as anxiety and personality vulnerabilities. The present randomized controlled trial aims to study the efficacy of UP in addressing the depressive symptomatology and the underlying transdiagnostic, emotional processes by comparing the intervention and treatment as usual groups. The treatment as usual group is defined in this study as all OP based services including medication and unstructured therapy. The pilot phase of the study consisting of a sample of 4 individual, 2 in each group, will focus on the familiarization of the modality, finalizing the number of sessions required and administration of the tools. The main phase of the study has an estimated sample size of 35 in each group (the intervention and treatment as usual group) and the therapy sessions will be given weekly for 12-15 sessions for the intervention group. They will initially be screened using DIAMOND and SCID-V PD followed by the outcome and process measures which are Montgomery-Asberg Depression Rating Scale (MADRS), Center for Epidemiological Studies – Depression Scale (CES-D), Hamilton Anxiety Rating Scale (HAM-A), Acceptance and Action Questionnaire II (AAQ-II), Distress Tolerance Scale (DTS), Difficulties in Emotion Regulation Scale (DERS) Positive and Negative Affect Scale (PANAS), Cognitive Flexibility Inventory (CFI), The Shortened General Attitudes and Beliefs Scale (SGABS), The Working Alliance Inventory- Client Form(WAI) and the Client Change Interview. The primary outcome measure MADRS will be administered during the baseline, post-intervention and follow-up through an independent assessor who is blinded while the other measures will be administered in the baseline, midpoint (6th or 7th session), post-intervention and follow-up. A tailor-made visual mood analogue scale will be given for everyday administration and a brief rating-interview schedule will be used to assess the transdiagnostic variables emotion regulation, distress tolerance and experiential avoidance. The Data from each phase will be recorded, analyzed and interpreted using appropriate statistical methods with SPSS/R softwares. Post normality testing, linear-mixed model will be used, with P value less than 0.05 will being considered as statistically significant. Liner-mixed model will be used to assess change across different time points between the two study groups and Pearson’s correlation coefficient or Spearman’s Rho will be used to assess the correlation between quantitative variables. Appropriate referrals will be provided if the participant decides to drop out and requests alternative treatment.

 

 
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