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NCT Number: NCT07239362

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

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.

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Key information

Conditions

Borderline Personality Disorder (BPD) Behavior Behavioral Symptoms Borderline Personality Disorder Depression Anxiety Disorder Dialectical Behavior Therapy Emotional Dysregulation Mental Disorders Personality Disorders Self Harm Self-Injurious Behavior Suicidal and Self-Injurious Behavior Suicide

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Association of Cognitive Therapists

Lahore, Punjab Province, Pakistan

Location contact

Laiba Qayyum, MSCP

CONTACT

[email protected]

+923021474287

Mirrat G. Butt, PhD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Culturally adapted DBT

Other

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 outcomes

  1. Emotional dysregulation

    Time frame: 18 Months

    As measured through participants' scores on the Difficulties in Emotion Regulation Scale-16 item version (DERS-16)

  2. Self-harm or suicide

    Time frame: 18 months

    As measured through the participants' scores on the Self-Harm Inventory, as well as the presence of any suicide attempt in participants' history

Secondary outcomes

  1. Borderline traits

    Time frame: 18 months

    As assessed through participants' scores on the Gul Mahmood Borderline Personality Traits Scale (GMBPTS)

  2. Depression and anxiety

    Time frame: 18 months

    As measured through participants' scores on Hospital Anxiety and Depression Scale (HADS)

  3. Functioning and disability

    Time frame: 18 months

    As assessed through the WHO Disability Assessment Schedule (WHODAS 2.0)

Sponsors and collaborators

Lead sponsor

Pakistan Association of Cognitive Therapists

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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