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

NCT07239362 | Not Yet Recruiting

• 1 other identifier: PACTDBT2025
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Borderline traits

  18 months

• Depression and anxiety

  18 months

• Functioning and disability

  18 months

Study Arms (2)

Culturally adapted DBT+Treatment as usual

EXPERIMENTAL

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

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.

Interventions

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.

Culturally adapted DBT+Treatment as usual

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Association of Cognitive Therapists: lead

Study Sites (1)

Pakistan Association of Cognitive Therapists

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Borderline Personality Disorder; Self-Injurious Behavior; Suicide

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Mirrat G. Butt, PhD

  PACT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)