Emotion DysregulationREACHNCT06963801
DBT-P Treatment Study
A study testing Moms2B and DBT-P in people with Emotion Dysregulation, run by Duke University at 1 site in United States.
Trial summary
The goal of this study is to find out if improving emotion regulation skills use during pregnancy reduces maternal stress and improves heart rate. The main questions it aims to answer are: Does improving emotion regulation skills during pregnancy reduce stress and improve the ability to cope? How is a participant's… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Emotion Dysregulation
- What is being tested?
- Moms2B and DBT-P
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2025to 19 Mar 2027
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Emotion dysregulation score of 88 or above
- At least 12 weeks pregnant
- Singleton Pregnancy
- Fluent in English
Who cannot join
- Active psychosis
- Drug or alcohol use disorder during pregnancy
- High risk of an imminent suicide attempt
- Significant health complications (e.g., cancer)
- Illiterate and/or unable to independently complete and comprehend written measures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27705
Alicia Holloway, (919) 684-1333, adh60@duke.edu
Janea Cato, (919) 684-3251, janea.cato@duke.edu
About this study
Official title: Developing Pregnancy-specific Dialectical Behavior Therapy Skills to Promote Multigenerational Mental Health
The goal of this study is to find out if improving emotion regulation skills use during pregnancy reduces maternal stress and improves heart rate.
The main questions it aims to answer are:
Read more
- Does improving emotion regulation skills during pregnancy reduce stress and improve the ability to cope?
- How is a participant's heart rate affected by their ability to control their emotions during pregnancy?
Researchers will test the hypothesis that dialectical behavior therapy skills groups (DBT-P) will improve emotion regulation skills use as well as heart rate.
Participants will:
- Visit the clinic for 3 sessions at the beginning, middle and end of their pregnancy.
- Compete surveys and interviews asking about their thoughts, feelings and how they cope with emotions.
- Have their heart rate taken.
- If assigned to the investigational group, they will complete weekly remote emotion regulation skills groups for 10 weeks and complete daily diary cards that ask about mood and any thoughts of self-harm.
- Optional Element: Complete a 20-30min infant neurobehavior exam (NNNS exam) after delivery.
Read the detailed description
The investigators' observational research with mothers with emotion dysregulation and their infants shows that poor emotion regulation skill use is a mechanism that likely confers risk for self-injurious thoughts and behaviors, depression, and anxiety in the mother and neurobehavioral and co-regulatory challenges in the infant. Emotion dysregulation is an impairing, early-emerging, transdiagnostic vulnerability factor that has intergenerational implications. Treatments have been developed for non-pregnant adults with emotion dysregulation but these are costly, time-intensive, and do not address the unique needs of pregnant people, highlighting an unmet therapeutic need. Through this innovative intervention, researchers will test whether targeting emotion regulation skills use during pregnancy will both improve postpartum emotion regulation, newborn neurobehavior, and mother-infant co-regulation. Early identification of the mechanisms implicated in risk. The researchers will deliver 10 weeks of DBT skills classes selected and adapted to meet the unique needs of pregnancy (DBT-P). The goal of this work is to improve perinatal mental health trajectories.
The premise of this study-that improving emotion regulation in pregnancy may disrupt intergenerational transmission of psychopathology-is informed by our research over the past two decades, including several NIH awards (R01MH119070, R01MH132210, R01DA049755, R21MH1090777, F31MH074196). The investigator' data reveal that maternal emotion dysregulation confers risk for mother. The research also shows that resting respiratory sinus arrhythmia (RSA), a physiological index of emotion dysregulation, can be improved via intervention in non-pregnant adults. The investigators propose that DBT-P will increase emotion regulation skills use or increase RSA in the mother (target engagement) leading to significant reductions in her emotion dysregulation prior to birth.
The primary study objectives are to recruit 100 pregnant women with high emotion dysregulation to receive either: (1) dialectical behavior therapy skills groups or an Assessment only control; and (2) to evaluate whether the treatment improved emotion regulation skills use as well as respiratory sinus arrhythmia.
- Conditions
- Emotion Dysregulation
- Being tested
- Moms2B, DBT-P
- Keywords
- Emotion dysregulation, Pregnancy, Maternal health, RSA, Coping, Stress, DBT-P, Moms2B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moms2BBehavioural
An established group-based pregnancy program focusing on improving nutrition, social, and medical support.
DBT-PBehavioural
An emotional skills group where emotion regulation skills are taught in the context of the pregnancy and expected life with an infant.
| Study group | Role | What they receive |
|---|---|---|
| Moms2B | Active comparator | Moms2B is an established group-based intervention for pregnant women focused on enhancing social support and improving nutrition. Participants will receive 3 sessions using this established assessment only treatment plan as well as complete surveys and clinical interviews assessing stress, coping strategies and emotions. Resting heart rate data as well as heart rate data post stimulus to be assessed. Receives: Behavioral: Moms2B |
| DBT-P | Experimental | DBT-P is a Dialectical Behavior Therapy skills group adapted for pregnant people. Participants will receive weekly DBT-P group sessions for 10 weeks where they learn skills to: (1) enhance self-awareness; (2) improve ability to manage crises; (3) decrease negative emotions and increase positive emotions; (4) improve your relationships and self-respect; they will also complete homework as part of the group participation as well as complete daily diary cards that will ask about their mood and any thoughts of self-harm .
Completion of surveys and clinical interviews assessing stress, coping strategies and emotions are included; resting heart rate data as well as heart rate data post stimulus to be assessed. Receives: Behavioral: Moms2B; Behavioral: DBT-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties in Emotion Regulation Scale (DERS)
The DERS is a 36-item measure scored on a 5-point Likert Scale. DERS scores range from 36-180 and enrollment in this study requires a baseline total DERS score of ≥88 which indicate greater difficulties in emotion regulation.
Measured: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Respiratory Sinus Arrhythmia (RSA)
RSA is a peripheral index of parasympathetic nervous system influences on cardiac activity and is measured as the variability in heart rate that coincides with respiration.
Measured: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Secondary outcomes (10)
Percent of participation
Feasibility of the assessment schedule will include the percent of participation at all timepoints.
Measured: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Percent of missing data
Feasibility of the assessment schedule will include the percent of missing data at all time points.
Measured: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Recruitment rates
Feasibility of the intervention will be assessed by evaluating recruitment rates.
Measured: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Reasons for refusal
Feasibility of the intervention will be assessed by evaluating reasons for refusal. Collection of reasons for refusal to be obtained via subject self-report at each individual timepoint; expected attendance for 85% of sessions.
Measured: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Intervention adherence
Feasibility of the intervention will be assessed by evaluating intervention adherence. Weekly assessment of intervention adherence conducted by clinicians based on subject completion of required homework assignments, daily diary entries and group session attendance.
Measured: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Number of women who complete all sessions
Feasibility will be assessed by how many women completed all sessions.
Measured: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Number of interventionists who can self-monitor for fidelity, assessed by watching segments of video-recorded sessions
Feasibility will be assessed by whether the interventionist can self-monitor for fidelity.
Measured: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Participation rates
Acceptability will be assessed by participation rates.
Measured: Post-treatment (Week 10)
Participant satisfaction with the intervention assessed by the Client Satisfaction Questionnaire
Acceptability will be assessed by measuring participant satisfaction with the intervention (including completion of the intervention) using the Client Satisfaction Questionnaire. Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Measured: Post-treatment (Week 10)
Telehealth acceptability specific to DBT skills training
A 41-item original survey developed by DBT experts in the United States and Australia to measure participants' satisfaction with DBT delivered through telehealth. Items designed to assess relevance of care experience on a 5-pt scale from Not Relevant to Very Relevant. Responses anonymized and qualitative free-text fields provided for recommendations and comments for changes or improvements.
Measured: Post-treatment (Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start6 Jun 2025
- Primary completion5 Mar 2027 (estimated)
- Study completion19 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion DysregulationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Two groups: control group is assessment only and treatment group is DBT-P group sessions (emotional skills regulation groups). Groups stratified based on gestational age (14-20 weeks vs 21-27 weeks) as well as race and ethnicity.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Oregon, Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Sponsor
- Investigators
- Elisabeth Conradt, PhD, Principal investigator, Duke UniversityAndrada Neacsiu, PhD, Principal investigator, Duke UniversitySheila Crowell, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963801
- Sponsor's protocol ID
- Pro00116252
- Other IDs
- R61MH138444
- Acronym
- REACH
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Pregnancy-specific Dialectical Behavior Therapy Skills to Promote Multigenerational Mental Health
- ClinicalTrials.gov ID
- NCT06963801
- Acronym / sponsor ID
- REACH / Pro00116252
- Conditions
- Emotion Dysregulation
- Keywords
- Emotion dysregulation, Pregnancy, Maternal health, RSA, Coping, Stress, DBT-P, Moms2B
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Oregon, Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 5 Mar 2027 (estimated)
- Study completion
- 19 Mar 2027 (estimated)
- First posted
- 9 May 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 goal of this study is to find out if improving emotion regulation skills use during pregnancy reduces maternal stress and improves heart rate.
The main questions it aims to answer are:
- Does improving emotion regulation skills during pregnancy reduce stress and improve the ability to cope?
- How is a participant's heart rate affected by their ability to control their emotions during pregnancy?
Researchers will test the hypothesis that dialectical behavior therapy skills groups (DBT-P) will improve emotion regulation skills use as well as heart rate.
Participants will:
- Visit the clinic for 3 sessions at the beginning, middle and end of their pregnancy.
- Compete surveys and interviews asking about their thoughts, feelings and how they cope with emotions.
- Have their heart rate taken.
- If assigned to the investigational group, they will complete weekly remote emotion regulation skills groups for 10 weeks and complete daily diary cards that ask about mood and any thoughts of self-harm.
- Optional Element: Complete a 20-30min infant neurobehavior exam (NNNS exam) after delivery.
Detailed description
The investigators' observational research with mothers with emotion dysregulation and their infants shows that poor emotion regulation skill use is a mechanism that likely confers risk for self-injurious thoughts and behaviors, depression, and anxiety in the mother and neurobehavioral and co-regulatory challenges in the infant. Emotion dysregulation is an impairing, early-emerging, transdiagnostic vulnerability factor that has intergenerational implications. Treatments have been developed for non-pregnant adults with emotion dysregulation but these are costly, time-intensive, and do not address the unique needs of pregnant people, highlighting an unmet therapeutic need. Through this innovative intervention, researchers will test whether targeting emotion regulation skills use during pregnancy will both improve postpartum emotion regulation, newborn neurobehavior, and mother-infant co-regulation. Early identification of the mechanisms implicated in risk. The researchers will deliver 10 weeks of DBT skills classes selected and adapted to meet the unique needs of pregnancy (DBT-P). The goal of this work is to improve perinatal mental health trajectories.
The premise of this study-that improving emotion regulation in pregnancy may disrupt intergenerational transmission of psychopathology-is informed by our research over the past two decades, including several NIH awards (R01MH119070, R01MH132210, R01DA049755, R21MH1090777, F31MH074196). The investigator' data reveal that maternal emotion dysregulation confers risk for mother. The research also shows that resting respiratory sinus arrhythmia (RSA), a physiological index of emotion dysregulation, can be improved via intervention in non-pregnant adults. The investigators propose that DBT-P will increase emotion regulation skills use or increase RSA in the mother (target engagement) leading to significant reductions in her emotion dysregulation prior to birth.
The primary study objectives are to recruit 100 pregnant women with high emotion dysregulation to receive either: (1) dialectical behavior therapy skills groups or an Assessment only control; and (2) to evaluate whether the treatment improved emotion regulation skills use as well as respiratory sinus arrhythmia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups: control group is assessment only and treatment group is DBT-P group sessions (emotional skills regulation groups). Groups stratified based on gestational age (14-20 weeks vs 21-27 weeks) as well as race and ethnicity.
| Arm | Type | Receives |
|---|---|---|
| Moms2B | Active comparator | Behavioral: Moms2BMoms2B is an established group-based intervention for pregnant women focused on enhancing social support and improving nutrition. Participants will receive 3 sessions using this established assessment only treatment plan as well as complete surveys and clinical interviews assessing stress, coping strategies and emotions. Resting heart rate data as well as heart rate data post stimulus to be assessed. |
| DBT-P | Experimental | Behavioral: Moms2B, Behavioral: DBT-PDBT-P is a Dialectical Behavior Therapy skills group adapted for pregnant people. Participants will receive weekly DBT-P group sessions for 10 weeks where they learn skills to: (1) enhance self-awareness; (2) improve ability to manage crises; (3) decrease negative emotions and increase positive emotions; (4) improve your relationships and self-respect; they will also complete homework as part of the group participation as well as complete daily diary cards that will ask about their mood and any thoughts of self-harm . Completion of surveys and clinical interviews assessing stress, coping strategies and emotions are included; resting heart rate data as well as heart rate data post stimulus to be assessed. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Emotion dysregulation score of 88 or above
- At least 12 weeks pregnant
- Singleton Pregnancy
- Fluent in English
Key exclusion criteria (5 listed)
- Active psychosis
- Drug or alcohol use disorder during pregnancy
- High risk of an imminent suicide attempt
- Significant health complications (e.g., cancer)
- Illiterate and/or unable to independently complete and comprehend written measures
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 |
|---|---|---|
| Moms2BAn established group-based pregnancy program focusing on improving nutrition, social, and medical support. | Behavioural | DBT-P, Moms2B |
| DBT-PAn emotional skills group where emotion regulation skills are taught in the context of the pregnancy and expected life with an infant. | Behavioural | DBT-P |
Primary outcome
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
The DERS is a 36-item measure scored on a 5-point Likert Scale. DERS scores range from 36-180 and enrollment in this study requires a baseline total DERS score of ≥88 which indicate greater difficulties in emotion regulation.
Respiratory Sinus Arrhythmia (RSA)
Time frame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
RSA is a peripheral index of parasympathetic nervous system influences on cardiac activity and is measured as the variability in heart rate that coincides with respiration.
10 secondary outcomes
Percent of participation
Time frame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Percent of missing data
Time frame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Recruitment rates
Time frame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Reasons for refusal
Time frame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Intervention adherence
Time frame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Number of women who complete all sessions
Time frame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Number of interventionists who can self-monitor for fidelity, assessed by watching segments of video-recorded sessions
Time frame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Participation rates
Time frame: Post-treatment (Week 10)
Participant satisfaction with the intervention assessed by the Client Satisfaction Questionnaire
Time frame: Post-treatment (Week 10)
Telehealth acceptability specific to DBT skills training
Time frame: Post-treatment (Week 10)
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 6 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Emotion Dysregulation
RecruitingObservational study
Alexithymia and Emotional Dysregulation in a Cohort of Pediatric Patients With Epilepsy
Alexithymia, Epilepsies
Recruiting
Predictors of Clinical Course and Treatment Response in DBT Programmes
Self Harm, Borderline Personality Disorder
Not yet recruiting
Unflavored Powdered Multivitamin in Children
Selective Eating, Emotional Dysregulation
Recruiting
Targeting Emotion Dysregulation to Reduce Suicide in People With Psychosis
Psychosis, Suicide
Recruiting
Progression of a Group of Patients Suffering From Emotional Dysregulation But Heterogeneous in Terms of Diagnosis, Benefiting From the DBT Group Programme.
Emotion Regulation, Emotional Disorder
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.
Elisabeth Conradt, PhD principal investigator
Duke University
Andrada Neacsiu, PhD principal investigator
Duke University
Sheila Crowell, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moms2B and DBT-P in people with Emotion Dysregulation, run by Duke University at 1 site in United States.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. 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 United States. 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?
Contact Janea Cato ((919) 684-3251, janea.cato@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in Emotion Regulation Scale (DERS) (time frame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)). 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 6 Oct 2026.