Borderline Personality Disorder (BPD)NCT07239362
CULTURALLY ADAPTED DIALECTICAL BEHAVIOR THERAPY FOR LOW-MIDDLE-INCOME COUNTRIES
A study testing Culturally adapted DBT in people with Borderline Personality Disorder (BPD) and Dialectical Behavior Therapy, run by Pakistan Association of Cognitive Therapists at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Borderline Personality Disorder (BPD), Dialectical Behavior Therapy, Emotional Dysregulation
- What is being tested?
- Culturally adapted DBT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Nov 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Pakistan Association of Cognitive Therapists
Lahore, Punjab Province
Laiba Qayyum, MSCP, +923021474287, laiba90012@gmail.com
Mirrat G. Butt, PhD
About this study
Official title: 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.
Read the 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).
- Conditions
- Borderline Personality Disorder (BPD), Dialectical Behavior Therapy, Emotional Dysregulation, Self Harm, Suicidal and Self-injurious Behavior, Depression Anxiety Disorder
- Being tested
- Culturally adapted DBT
- Keywords
- BPD, DBT, Self harm, Suicide, Borderline personality, Dialectical behavior therapy, Emotional dysregulation
- Medical subject headings
- Borderline Personality Disorder, Self-Injurious Behavior, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally adapted DBTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional dysregulation
As measured through participants' scores on the Difficulties in Emotion Regulation Scale-16 item version (DERS-16)
Measured: 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
Measured: 18 months
Secondary outcomes (3)
Borderline traits
As assessed through participants' scores on the Gul Mahmood Borderline Personality Traits Scale (GMBPTS)
Measured: 18 months
Depression and anxiety
As measured through participants' scores on Hospital Anxiety and Depression Scale (HADS)
Measured: 18 months
Functioning and disability
As assessed through the WHO Disability Assessment Schedule (WHODAS 2.0)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start20 Nov 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality Disorder (BPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Association of Cognitive Therapists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirrat G. Butt, PhD, Principal investigator, PACT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239362
- Sponsor's protocol ID
- PACTDBT2025
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Dialectical Behavior Therapy (DBT) for Mental Health in LMICs: A Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT07239362
- Acronym / sponsor ID
- PACTDBT2025
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Pakistan Association of Cognitive TherapistsUniversity, hospital or other
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Culturally adapted DBT+Treatment as usual | Experimental | Other: Culturally adapted DBTIn 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally adapted DBTParticipants 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 |
Primary outcome
Emotional dysregulation
Time frame: 18 Months
As measured through participants' scores on the Difficulties in Emotion Regulation Scale-16 item version (DERS-16)
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
3 secondary outcomes
Borderline traits
Time frame: 18 months
Depression and anxiety
Time frame: 18 months
Functioning and disability
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mirrat G. Butt, PhD principal investigator
PACT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally adapted DBT in people with Borderline Personality Disorder (BPD) and Dialectical Behavior Therapy, run by Pakistan Association of Cognitive Therapists at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional dysregulation (time frame: 18 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.