| CTRI Number |
CTRI/2024/01/061602 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Dialectical behavior therapy for Borderline Personality Disorder |
|
Scientific Title of Study
|
Brief Dialectical Behaviour Therapy Group Skills Training as a standalone psychotherapy for Individuals with Borderline Personality Disorder |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Diksha Dugar |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Hosur road, Bengaluru
India
Bangalore
KARNATAKA
560029
India |
| Phone |
9990297968 |
| Fax |
|
| Email |
dugardiksha.aud@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Manjula |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Hosur road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995182 |
| Fax |
|
| Email |
drmanjula71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Diksha Dugar |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Hosur road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9990297968 |
| Fax |
|
| Email |
dugardiksha.aud@gmail.com |
|
|
Source of Monetary or Material Support
|
| UGC JRF Scholarship 495(NET-JULY 2018) University Grants Commission (UGC)Bahadur Shah Zafar Marg New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
UGC JRF Scholarship 495(NET-JULY 2018) University Grants Commission |
| Address |
Bahadur Shah Zafar Marg New Delhi 110002 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Diksha Dugar |
National Institute of Mental Health and Neurosciences |
Behavioural Medicine Unit, Department of Clinical Psychology, Basement, M. V. Govindaswamy building, National Institute of Mental Health and Neurosciences, Hosur road, Bengaluru-560029
Bangalore
KARNATAKA |
9990297968
dugardiksha.aud@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Mental Health and Neurosciences Institutional Ethics Commitee (Behavioural Sciences division) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F603||Borderline personality disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief Dialectical Behaviour Therapy Group Skills Training (DBT-ST) |
Dialectical Behavior Therapy is a comprehensive, empirically validated first line treatment for Borderline Personality Disorder. The standard DBT comprise of four components- Individual Therapy, Skills training, Telephone coaching and therapist consultation team. Intervention in the present study however will be limited to DBT Skills training component. Literature suggests that DBT skills training alone can result in large improvements in domain of self-harm as well as psychosocial functioning. The DBT Skills training comprises of 4 modules (mindfulness, distress tolerance, interpersonal effectiveness and emotion regulation) and typically takes around 12 months in the standard DBT therapy. However, in the present study, the schedule that will be followed is based on Soler (2009) 13 week schedule. There will be weekly sessions of 120 mins for a duration of 12-14 weeks for patient with Borderline Personality Disorder. This will be conducted in a group format with 6-8 participants via either online or offline mode. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18–60 years,
2. meeting diagnostic criteria for BPD according to the Structured Clinical Interview for DSM-V Personality Disorders (SCID-5 PD),
3. able to read and understand English,
4. able to commit to attending 12-13 weeks of DBT skills training in the hospital’s outpatient clinic.
5. All genders |
|
| ExclusionCriteria |
| Details |
1. Current comorbidity with schizophrenia, drug-induced psychosis, alcohol or other psychoactive substance dependence, bipolar disorder, major depressive episode with current suicidal risk,
2. Symptoms of axis 1 disorders which interfere with engagement in therapy for personality disorder.
3. Having an organic brain disorder or intellectual disability.
4. Have taken DBT psychotherapy in the past or is currently undergoing psychotherapy for personality disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BPD symptoms severity |
baseline, post intervention assessment,3-month follow-up and 6-month follow-up (if possible) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Non-suicidal self-injury (NSSI) |
baseline, post intervention assessment, 3-month follow-up and 6-month follow-up (if possible) |
| Emotion regulation |
baseline, post intervention assessment, 3-month follow-up and 6-month follow-up (if possible) |
| Anxiety and depressive symptoms |
baseline, post intervention assessment,3-month follow-up and 6-month follow-up (if possible) |
| Global Functioning |
baseline, post intervention assessment,3-month follow-up and 6-month follow-up (if possible) |
| DBT skill use |
Pre-intervention Assessment, after every module, 3-month follow-up and 6-month follow-up (if possible) (Total 7 time points) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/02/2024 |
| 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="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 [dugardiksha.aud@gmail.com].
- For how long will this data be available start date provided 20-10-2027 and end date provided 20-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
Modification(s)
|
Borderline Personality Disorder (BPD) is highly prevalent personality disorder associated with intense psychosocial distress to the patient and people around them. Highly cost intensive treatments available for this condition may not be feasible in Indian out-patient psychiatric settings. Brief Dialectical Behaviour Therapy Group Skills Training (DBT-ST) can be a judicious intervention in Indian settings due to the cost-effective nature of the treatment. However, DBT-ST have not been studied in Indian context. Thus, this research aims to study the effect of brief Dialectical Behaviour Therapy Skills Training (DBT- ST) for patient with BPD on various primary and secondary outcome variables.
A single group pre-post design will be used. The study will be conducted in two phases. The Pilot phase will include modification of brief DBT-ST schedule by Soler et al (2009) based on insights from running the DBT skills group with 4-6 participants and expert validation of the same.
The main phase will include administering the modified schedule to 30 participants diagnosed with BPD which will require running 4-6 psychotherapy groups with 6-8 participants. The screening will be done using Diagnostic interview for anxiety, mood, and obsessive-compulsive and related neuropsychiatric disorders (DIAMOND; Tolin et al., 2018) and Structured Clinical Interview for DSM-V Personality Disorders (SCID-V PD; First, 2014). The outcome variables will be assessed at baseline, mid-intervention assessment, post-intervention and at 3-months follow-up using Borderline Evaluation of Severity over Time (BEST; Pfohl & Blum, 1997), Difficulties in Emotional Regulation Scale-18 (DERS-18; Victor & Klonsky, 2016), DBT ways of coping checklist (DBT-WCCL; Vitaliano, et. al., 1985), Depression, Anxiety and Stress Scale - 21 (DASS-21; Lovibond & Lovibond, 1995) and Global Assessment of Functioning (GAF; DSM-IV-TR, 2000). Clinical Global Impression Scale- Borderline Personality Disorder (CGI- BPD; Perez et al., 2007) will be applied pre- and post intervention whereas Deliberate Self-Harm Inventory (DSHI; Gratz, 2001) will be applied at 3 time points: pre-, post-intervention and 3 month follow up. VAS will be assessed after every session. Focus Group Discussion will be held post-intervention.
Data obtained in each phase will be recorded, coded and analysed using suitable qualitative and quantitative methods. Suitable software may be used to transcribe and organize the qualitative data from FGD. Content analysis will be used to understand the data. The quantitative data will be tabulated and subjected to statistical analysis using Statistical Package for Social Sciences (SPSS version 23). Descriptive statistics (e.g., mean, standard deviation) will be used to describe the demographical and clinical characteristics of the sample. Normality of the data will be assessed using Shapiro-Wilk test. Appropriate tests of association based on the normality of the sample will be carried out to study the association between the different variables considered in this study. The study may use hierarchical linear model to compare the data at different time points. P value less than 0.05 will be considered as statistically significant. The participants will be regularly assessed for suicidal risk. Crisis plan will be made collaboratively with participants and their consent will be taken to involve a designated contact person before commencing the treatment. In case patients require any emergency or psychiatric services, referrals and contacts will be provided for the same. |