Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07239362
Enrollment
220
Registered
2025-11-20
Start date
2025-11-20
Completion date
2026-07-31
Last updated
2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder (BPD), Depression Anxiety Disorder, Dialectical Behavior Therapy, Emotional Dysregulation, Self Harm, Suicidal and Self-injurious Behavior

Keywords

BPD, DBT, Self harm, Suicide, Borderline personality, Dialectical behavior therapy, Emotional dysregulation

Brief summary

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

OTHERCulturally 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.

Sponsors

Pakistan Association of Cognitive Therapists
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

This will be a rater-blind RCT to evaluate the feasibility and acceptability of culturally adapted DBT in addition to treatment as usual (TAU) compared with TAU only in Pakistan. This study will employ a pre-post measure and parallel design over 18 months.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Emotional dysregulation18 MonthsAs measured through participants' scores on the Difficulties in Emotion Regulation Scale-16 item version (DERS-16)
Self-harm or suicide18 monthsAs measured through the participants' scores on the Self-Harm Inventory, as well as the presence of any suicide attempt in participants' history

Secondary

MeasureTime frameDescription
Borderline traits18 monthsAs assessed through participants' scores on the Gul Mahmood Borderline Personality Traits Scale (GMBPTS)
Depression and anxiety18 monthsAs measured through participants' scores on Hospital Anxiety and Depression Scale (HADS)
Functioning and disability18 monthsAs assessed through the WHO Disability Assessment Schedule (WHODAS 2.0)

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026