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Trial registered on ANZCTR
Registration number
ACTRN12625001021460
Ethics application status
Approved
Date submitted
10/08/2024
Date registered
15/09/2025
Date last updated
15/09/2025
Date data sharing statement initially provided
15/09/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effectiveness of Dialectical behavior therapy intervention for borderline personality traits among adolescents: A randomized control trial
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Scientific title
Effectiveness of Dialectical behavior therapy intervention for borderline personality traits among adolescents: A randomized control trial
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Secondary ID [1]
312729
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Borderline Personality traits
334750
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Emotional dysregulation
334751
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Depression
334752
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Anxiety
334753
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Stress
334754
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low self esteem
334756
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Suicidal Ideation
334757
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Coping style
336675
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Condition category
Condition code
Mental Health
331311
331311
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0
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Psychosis and personality disorders
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Mental Health
331312
331312
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0
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Studies of normal psychology, cognitive function and behaviour
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Mental Health
331313
331313
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0
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Depression
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Mental Health
331314
331314
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0
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Anxiety
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Mental Health
331315
331315
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0
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Suicide
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The treatment group attended weekly group-based DBT skills training sessions for a total of 8 weeks. Each session lasted 90 minutes and included a 5-minute mindfulness exercise, a review of the weekly topic, and group discussions. This DBT Skills training program covered five key modules: Basic DBT Skill’s training Introduction, Mindfulness, Distress Tolerance, Emotion Regulation, and Interpersonal Effectiveness.
The intervention was based on standardized Dialectical Behavior Therapy (DBT) resources, including the DBT Skills Manual for Adolescents (Rathus & Miller, 2014), Expanded Dialectical Behavior Therapy Skills Training Manual (Pederson & Pederson, 2017), the Dialectical Behavior Therapy Skills Training with Adolescents: A Practical Workbook for Therapists, Teens & Parents (Eich, 2020) and DBT Skills Training Handouts and Worksheets (2nd ed.) (Linehan, 2015) were utilized. Participants practiced worksheets during session to support their learning and practice of DBT skills.
This intervention consists of eight group based Dialectical Behavior Therapy (DBT) skills training for young adults with Borderline Personality symptoms. Each session introduces and practices specific DBT skills:
Session 1: Mindfulness Skills
Teaching "What" (Observe, Describe, Participate) and "How" (Non-Judgmentally, One-Mindfully, Effectively) skills to enhance present-moment awareness and emotional regulation. Includes Loving-Kindness practice.
Session 2: Crisis Survival Skills
Strategies for distress tolerance, including Wise Mind ACCEPTS (distraction techniques), self-soothing, improving the moment, half-smile technique, and creative outlets for emotional regulation.
Session 3: Reality Acceptance Skills
Teaching Pros and Cons evaluation, Radical Acceptance, Turning the Mind, and Willingness to accept and manage difficult emotions and situations.
Session 4: Emotional Self-Care & Mastery
Focus on physical and emotional well-being through self-care (PLEASE), building mastery, task engagement, and self-recognition of achievements.
Session 5: Emotion Regulation Skills
Building positive experiences, practicing the opposite action to difficult emotions, and allowing emotions to be experienced and processed healthily.
Session 6: Interpersonal Effectiveness Basics
Understanding relationship beliefs, balancing independence and support, evaluating interpersonal needs, and practicing skills for effective communication.
Session 7: Advanced Interpersonal Effectiveness
Enhancing relationships through GIVE skills, assertiveness training (DEAR MAN), and self-respect strategies (FAST).
Session 8: Boundaries & Review
Setting and evaluating personal boundaries, summarizing learned DBT skills, and reviewing progress in applying them to daily life.
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Intervention code [1]
329251
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Treatment: Other
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Intervention code [2]
329384
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Behaviour
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Comparator / control treatment
Waitlist Control Group
Participants in the waitlist control group will not receive group DBT skills training during the initial 8 weeks but will be offered the same 8-week group based sessions of DBT skills training program after the study period. This group will serve as a comparison to evaluate the effectiveness of the DBT skills training against no immediate intervention.
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Control group
Active
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Outcomes
Primary outcome [1]
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Participant Borderline Personality traits
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Assessment method [1]
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Borderline Personality Disorder symptoms was assessed using the 10-item McLean Screening Instrument for BPD (MSI-BPD), a self-report tool with dichotomous scoring (0-10), where a score of =7 indicates a higher likelihood of BPD symptoms.
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Timepoint [1]
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Screening (Baseline ) and after 8 week post-intervention
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Primary outcome [2]
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Emotion Dysregulation
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Assessment method [2]
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Emotion dysregulation was assessed using the 16-item Difficulties in Emotion Regulation Scale (DERS-16), a five-point Likert scale (1-5), with higher scores (16-80) indicating greater difficulties in emotion regulation.
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Timepoint [2]
339076
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Screening At baseline, before the intervention begins and (Post-intervention assessment) after all 8 sessions are completed.
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Secondary outcome [1]
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Depression
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Assessment method [1]
438477
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Depression was assessed using the 21-item DASS-21, a self-report tool with three 7-item subscales, rated on a 4-point scale, with higher scores (0-21) indicating greater symptom severity.
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Timepoint [1]
438477
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Pre intervention and post-intervention
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Secondary outcome [2]
438478
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Coping skills
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Assessment method [2]
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Coping skills was assessed using the 28-item Brief-COPE, a self-report tool with three subscales (Problem-Focused, Emotion-Focused, Avoidant Coping), rated on a 4-point Likert scale, with higher scores indicating greater use of coping strategies.
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Timepoint [2]
438478
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Pre intervention and post-intervention
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Secondary outcome [3]
438479
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Self-esteem
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Assessment method [3]
438479
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Self-esteem was assessed using the 10-item Rosenberg Self-Esteem Scale, a self-report tool rated on a 4-point Likert scale, with higher scores indicating greater self-esteem.
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Timepoint [3]
438479
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Pre intervention and post-intervention
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Secondary outcome [4]
438480
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Suicidal ideation
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Assessment method [4]
438480
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Suicidal ideation was assessed using the 5-item Suicidal Ideation Attributes Scale (SIDAS), a self-report tool rated on a 0-10 scale, with higher scores (0-50) indicating greater suicidal ideation severity.
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Timepoint [4]
438480
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Pre intervention and post-intervention
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Secondary outcome [5]
439709
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Anxiety
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Assessment method [5]
439709
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Anxiety was assessed using the 21-item DASS-21, a self-report tool with three 7-item subscales, rated on a 4-point scale, with higher scores (0-21) indicating greater symptom severity.
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Timepoint [5]
439709
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Pre intervention and post-intervention
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Secondary outcome [6]
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Stress
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Assessment method [6]
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Stress was assessed using the 21-item DASS-21, a self-report tool with three 7-item subscales, rated on a 4-point scale, with higher scores (0-21) indicating greater symptom severity.
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Timepoint [6]
439710
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Pre intervention and post-intervention
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Eligibility
Key inclusion criteria
Participants will be eligible for the study if they are aged between 15 and 18 years, as this range represents the developmental stage of adolescence. Adolescents under the age of 18 will require parental or guardian consent, ensuring ethical compliance. To accommodate participants already enrolled, individuals who turn 19 during the study will also remain eligible to avoid disruption of their participation. Eligibility will further depend on participants scoring =40 on the Difficulties with Emotion Regulation Scale-16 (DERS-16) (Bjureberg et al., 2016) and/or responding “yes” to seven or more items on the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) (Zanarini et al., 2003).
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Minimum age
15
Years
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Previous participation in Dialectical Behavior Therapy (DBT).
Presence of a hearing impairment that could interfere with their ability to participate.
Current experience of serious medical or psychological conditions, as such conditions could confound study outcomes.
Acute withdrawal from alcohol or drugs at the time of recruitment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After confirming participants’ eligibility, allocation was done by sealed opaque envelopes to effectively minimize bias in this study. For this purpose, 52 envelopes were prepared; 26 for the “treatment” group and 26 for the “control” group. All envelopes were then sealed and mixed thoroughly in a container to ensure randomness. When an eligible participant was to be assigned, an envelope was drawn from the shuffled container without prior knowledge of its content, which determined whether the participant was in the “treatment” or “control” group. This method was used to ensure that the process was random and concealed, reducing potential bias.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization for this study was achieved by using the lottery method. Each participant’s identifier was placed into a container, e.g., a box. Then the participants’ assignments to either the treatment or control group were drawn randomly. This method ensured that all participants had an equal chance of being assigned to any group, thereby maintaining a random and unbiased allocation process.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Data analysis was conducted using IBM Statistics version 27. Descriptive statistics were calculated for all study variables. Baseline comparisons between the treatment and control groups were conducted using independent sample t-tests to ensure the effectiveness of randomization. Paired sample t-tests were performed to assess within-group changes over time from pre- to post-intervention for each variable. A multivariate analysis was conducted to examine the effect of gender, group (experimental vs. Control) and their interaction. Furthermore, repeated measures manova was performed to evaluate the effect of time ( pre vs. Post), group and their interaction effect on all study variables.Statistical significance was set at p < .05. All analyses were conducted following the intention-to-treat principle to account for all participants initially randomized to groups.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/02/2025
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Date of last participant enrolment
Anticipated
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Actual
3/02/2025
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Date of last data collection
Anticipated
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Actual
3/04/2025
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Sample size
Target
52
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Accrual to date
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Final
52
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Recruitment outside Australia
Country [1]
26499
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Pakistan
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State/province [1]
26499
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Punjab
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Funding & Sponsors
Funding source category [1]
317406
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Self funded/Unfunded
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Name [1]
317406
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Ilsa Gul
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Address [1]
317406
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Country [1]
317406
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Pakistan
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Primary sponsor type
Individual
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Name
Ms. Ilsa Gul - National University of Medical Sciences, Rawalpindi,
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Address
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Country
Pakistan
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Secondary sponsor category [1]
322462
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None
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Name [1]
322462
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Address [1]
322462
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Country [1]
322462
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315907
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National University of Medical Sciences' (NUMS) Institutional Review Board and Ethical Committee (IRB & EC)
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Ethics committee address [1]
315907
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Office of Research Innovation and Commercialization (ORIC) National University of Medical Sciences phone: +92 51 5170661, +92 51 9270677 Email: oric@numspak.edu.pk
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Ethics committee country [1]
315907
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Pakistan
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Date submitted for ethics approval [1]
315907
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12/08/2024
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Approval date [1]
315907
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31/01/2025
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Ethics approval number [1]
315907
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31/01/2025
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Summary
Brief summary
The study investigated the effectiveness of an 8-week group-based Dialectical Behavior Therapy (DBT) skills training program for adolescents with emerging Borderline Personality Disorder (BPD) symptoms. A total of 52 eligible participants aged 15–18 were randomized into either a DBT intervention group or a waitlist control group. Standardized measures were used to assess BPD symptoms, emotional regulation, depression, anxiety, stress, suicidal ideation, coping styles, and self-esteem before and after the intervention. Results showed significant improvements in the DBT group across all outcomes, including reduced emotional and behavioral difficulties and enhanced coping and self-esteem. The findings support DBT as an effective non-pharmacological approach for improving adolescent mental health in educational settings.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Ilsa Gul
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Address
136174
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National University of Medical Sciences (NUMS) PWD Campus PWD Housing Society Rawalpindi Postal Code 46000 Pakistan
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Country
136174
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Pakistan
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Phone
136174
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+923023388450
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Fax
136174
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Email
136174
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[email protected]
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Contact person for public queries
Name
136175
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Ilsa Gul
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Address
136175
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National University of Medical Sciences (NUMS) PWD Campus PWD Housing Society Rawalpindi Postal Code 46000 Pakistan
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Country
136175
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Pakistan
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Phone
136175
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+923023388450
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Fax
136175
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Email
136175
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[email protected]
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Contact person for scientific queries
Name
136176
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Ilsa Gul
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Address
136176
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National University of Medical Sciences (NUMS) PWD Campus PWD Housing Society Rawalpindi Postal Code 46000 Pakistan
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Country
136176
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Pakistan
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Phone
136176
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+923023388450
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Fax
136176
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Email
136176
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
The individual participant data (IPD) for this trial will not be made available. This decision is based on several important considerations. First, the study involves sensitive information related to Borderline Personality Disorder traits, emotional dysregulation, and suicidality. To ensure the privacy and confidentiality of the participants, it is crucial to keep their data secure and private. Upholding ethical standards and respecting the terms of participant consent is a priority. Lastly, as a sole researcher working within a limited timeframe, I lack the resources necessary to anonymize and prepare the data for public sharing in a way that fully adheres to ethical guidelines. Therefore, the IPD will remain confidential and will not be shared.
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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