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Not yet recruiting NCT07239362

CULTURALLY ADAPTED DIALECTICAL BEHAVIOR THERAPY FOR LOW-MIDDLE-INCOME COUNTRIES

No phase Interventional Borderline Personality Disorder (BPD) Dialectical Behavior Therapy Emotional Dysregulation Self Harm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Culturally adapted DBT.
Who it may be relevant to
Registry conditions: Borderline Personality Disorder (BPD), Dialectical Behavior Therapy, Emotional Dysregulation, Self Harm. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Culturally Adapted Dialectical Behavior Therapy (DBT) for Mental Health in LMICs: A Randomized Controlled Trial (RCT)

Overview

The study aims to assess the efficacy of culturally adapted dialectical behaviour therapy (DBT) for addressing emotional dysregulation in a low- and middle-income country, as well as to evaluate the impact of DBT on secondary outcomes such as borderline personality traits, self-harm or suicide, depression, anxiety, and individuals' functioning and disability. Through a rigorous Randomised Controlled Trial (RCT), the research seeks to assess how cultural adaptations of dialectical behaviour therapy improve its applicability, engagement, and outcomes in diverse socio-cultural settings, contributing to more accessible and effective mental health interventions in resource-limited regions.

Detailed description

DBT has proven successful in high-income countries; its application in low- and middle-income countries (LMICs) is limited despite the significant mental health burden in these regions. Mental health challenges in LMICs are further compounded by socio-cultural, economic, and infrastructural barriers, highlighting the need for culturally sensitive adaptations of evidence-based therapies. Culturally adapted DBT involves modifying therapeutic components to align with local norms, values, and language, while maintaining its core strategies, including mindfulness, emotion regulation, interpersonal effectiveness, and distress tolerance. Randomised Controlled Trials (RCTs) are essential to evaluate the feasibility, acceptability, and efficacy of such culturally tailored interventions, helping bridge the mental health treatment gap in LMICs. The current study aimed to evaluate the feasibility, acceptability, and clinical effectiveness of a culturally adapted Dialectical Behaviour Therapy (DBT) intervention for addressing mental health challenges in low- and middle-income countries (LMICs) as compared to treatment as usual (TAU).

Interventions

  • Other Culturally adapted DBT
    Participants will receive culturally translated and adapted dialectical behaviour therapy (DBT) materials that fit local cultural and linguistic contexts. Such material will include culturally relevant metaphors, examples, and mindfulness practices. Sessions will be conducted in the form of weekly group skills training (emotion regulation, distress tolerance, interpersonal effectiveness, mindfulness), individual therapy sessions (1 hour/week), and telephone coaching as needed.

Primary outcome measures

  • Emotional dysregulation [Time frame: 18 Months]
  • Self-harm or suicide [Time frame: 18 months]
Secondary outcome measures (3)
  • Borderline traits [Time frame: 18 months]
  • Depression and anxiety [Time frame: 18 months]
  • Functioning and disability [Time frame: 18 months]

Eligibility criteria

Inclusion criteria

  • Adults aged 18-45 years
  • Adults who are diagnosed with or have significant traits of borderline personality disorder (BPD)
  • Adults who are willing to provide written informed consent

Exclusion criteria

  • Severe psychiatric comorbidity (e.g., active psychosis, substance use, etc.)
  • Acute medical conditions interfering with participation
  • Lack of basic reading and writing, or any learning disability

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Pakistan Association of Cognitive Therapists — Lahore

Identifiers

NCT: NCT07239362 · PACTDBT2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗