Psychotherapy for depression linked to childhood trauma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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: 905 522 1155

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.