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

NCT07239362 — Not applicable, Not yet recruiting, 220 participants, Pakistan Association of Cognitive Therapists

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

Registry	NCT07239362
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	220 (Estimated)
Sponsor	Pakistan Association of Cognitive Therapists (Other)
Conditions	Borderline Personality Disorder (BPD), Dialectical Behavior Therapy, Emotional Dysregulation, Self Harm, Suicidal and Self-injurious Behavior, Depression Anxiety Disorder
Interventions	Culturally adapted DBT (Other)
Dates	start 2025-11-20 (estimated), primary completion 2026-06-01 (estimated), completion 2026-07-31 (estimated), first posted 2025-11-20, last updated 2025-11-28
Locations	1 site in Pakistan

-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.

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+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).

+Arms and interventions

Arm	Type	Interventions	Description
Culturally adapted DBT+Treatment as usual	Experimental	Other: Culturally adapted DBT	In addition to the usual treatment (TAU), which typically involves pharmacotherapy or supportive counselling from a general physician, 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.
Treatment as usual (TAU) only	No intervention		Participants will only receive standard mental health care available in the region (e.g., medication, supportive counselling), usually from a general physician. TAU in Pakistan largely consists of pharmacological treatment with medication and follow-up in an outpatient basis.

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.

+Outcome measures

Primary outcomes

Emotional dysregulation [18 Months]: As measured through participants' scores on the Difficulties in Emotion Regulation Scale-16 item version (DERS-16)
Self-harm or suicide [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

Borderline traits [18 months]: As assessed through participants' scores on the Gul Mahmood Borderline Personality Traits Scale (GMBPTS)
Depression and anxiety [18 months]: As measured through participants' scores on Hospital Anxiety and Depression Scale (HADS)
Functioning and disability [18 months]: As assessed through the WHO Disability Assessment Schedule (WHODAS 2.0)

+Eligibility

Sex: All, ages: 18 Years to 45 Years

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

+Locations (1)

Facility	City	Country	Status
Pakistan Association of Cognitive Therapists	Lahore, Punjab Province	Pakistan

+Investigators

Mirrat G. Butt, PhD, Principal investigator, PACT