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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Self Harm; Suicidal and Self-injurious Behavior; Depression Anxiety Disorder; Emotional Dysregulation; Borderline Personality Disorder (BPD); Dialectical Behavior Therapy
• Intervention / Treatment: Other: Culturally adapted DBT

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).

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan
      • Pakistan Association of Cognitive Therapists
      • Contact: Laiba Qayyum, MSCP; Phone Number: +923021474287; Email: laiba90012@gmail.com
      • Principal Investigator: Mirrat G. Butt, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Culturally adapted DBT+Treatment as usual; 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.	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.
No Intervention: Treatment as usual (TAU) only; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional dysregulation	As measured through participants' scores on the Difficulties in Emotion Regulation Scale-16 item version (DERS-16)	18 Months
Self-harm or suicide	As measured through the participants' scores on the Self-Harm Inventory, as well as the presence of any suicide attempt in participants' history	18 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pakistan Association of Cognitive Therapists
• Investigators: Principal Investigator: Mirrat G. Butt, PhD, PACT

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 15, 2025
• First Posted (Estimated): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Suicide; BPD; DBT; Dialectical behavior therapy; Self harm; Emotional dysregulation; Borderline personality
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Personality Disorders; Behavior; Suicide; Borderline Personality Disorder; Self-Injurious Behavior
• Other Study ID Numbers: PACTDBT2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No