| 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
|
|
|
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
|
|
|
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. |