Psychotherapy for depression linked to childhood trauma
Resolving Early Life Stress: Psychotherapy Outcomes and Neurobiology in Complex Depression
This project will try a new one-on-one online therapy to see if it reduces depression and emotional dysregulation in adults who experienced childhood adversity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | St. Joseph's Healthcare Hamilton Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT07250893 on ClinicalTrials.gov |
What this trial studies
RESPOND is an open-label, single-arm proof-of-concept study testing a novel psychotherapy that blends techniques from DBT, CBT, and CPT specifically tailored for people with depressive symptoms and early life adversity. Participants receive virtual, individualized therapy and complete clinical assessments while providing blood samples to measure inflammatory and epigenetic markers. The primary clinical outcome is change in MADRS depressive symptoms; secondary outcomes include changes on the DERS, PCL-5, ITQ, and biological measures of inflammation and DNA methylation. The study seeks to link symptom change to biological and trauma-related mechanisms to inform future, larger trials.
Who should consider this trial
Good fit: Adults 18 or older with moderate-to-severe depressive symptoms (HAM-D ≥18) and documented childhood adversity on the CECA-Q or ACEs questionnaire.
Not a fit: People with adult-onset PTSD without childhood adversity, active mania or psychosis, active substance use disorder, current high suicide risk, or those already in regular psychotherapy are excluded and may not benefit from this intervention.
Why it matters
Potential benefit: If successful, the therapy could reduce depressive symptoms and improve emotional regulation for adults affected by childhood adversity.
How similar studies have performed: CBT, DBT, and CPT components have shown benefit for depression and trauma in prior research, but combining them into an early-life-adversity–tailored protocol is novel and not yet proven in larger trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 18 years old or older * At or above 18 on HAM-D, indicative of moderate-severe depressive symptoms * Any childhood (before 18 years old) adversity as indicated by scores on the CECA q and ACES q Exclusion Criteria: * Individuals who meet for PTSD diagnosis from a criterion A trauma occurring in adulthood without a history of ELA * Individuals experiencing active mania or psychosis * Individuals with an active substance use disorder * Individuals presenting with active suicide risk (plan, intention, means) indicative of a need for higher level care * Individuals in current psychotherapeutic treatment (defined as having engaged in consistent psychotherapy within the last 3 months)
Where this trial is running
Hamilton, Ontario
- St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Benicio Frey, MD, PhD — St. Joseph's Healthcare Hamilton
- Study coordinator: Katerina Dikaios, MSc
- Email: dikaiosk@mcmaster.ca
- Phone: 9028779750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.