Resolving Early Life Stress: Psychotherapy Outcomes and Neurobiology in Complex Depression

NCT07250893 · tracked via the Priya Life Science Canada tracker

Sponsor

St. Joseph's Healthcare Hamilton

Phase

Not applicable

Started

2025-10-25

Last updated

2026-07-14

Condition(s) studied

Depression - Major Depressive DisorderChildhood Traumas

Investigational drug(s) / intervention(s)

Psychotherapy

Psychotherapy: Session 1 - Psychoeducation: Introductions + information about adversity and depression Session 2 - Behavioural Activation: Identify activation targets, create Daily Activities Schedule Session 3 - Identifying Emotions: Describe + label emotions; cycle of emotions Session 4 - Distress Tolerance: STOP + TIP skills Session 5 - Distress Tolerance: Self-soothing + improving the moment Session 6 - Stuck Points: Stuck points + impact statements Session 7 - Self-blame Beliefs: Negative self schemas; alternative thoughts worksheet Session 8 - Safety + Trust: Schemas of emotional safety and trust about self and others Session 9 - Power + Control: Stuck points related to scope of influence over events + the world Session 10 - Esteem: Reconstruct ideas of self; engaging positively with others Session 11 - Intimacy: Develop self- and other intimacy behaviours Session 12 - Wrap-up: Review new impact statements; revisit behavioural chang

Study summary

The RESPOND trial explores the link between early life adversity and later life depressive symptoms. The investigators have designed a new psychological therapy tailored to address the symptoms that can be caused by difficult experiences in early life. These symptoms include low mood, emotional dysregulation, and distressing thoughts and beliefs related to difficult or traumatic experiences. The investigators would like to see if this new therapy helps people feel better. The investigators are also studying the biological changes that can occur as a result of early life adversity, and how this therapy may influence those changes. To do this, the investigators ask questions about participants' physical and mental health and take blood samples.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

65 Years

Healthy volunteers

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)

Primary outcome measure(s)

Montgomery and Asberg Depression Rating Scale (MADRS) — Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment)
The Montgomery and Asberg Depression Rating Scale is a 10-item semi-structured interview assessing the severity of depressive symptoms (Montgomery \& Åsberg, 1979). The MADRS is sensitive to changes induced my treatment, making it appropriate to implement over psychotherapeutic intervention to monitor changes in depression severity.

Trial sites (1)

Facility	City	Region	Status
St. Joseph's Healthcare Hamilton	Hamilton	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07250893 on ClinicalTrials.gov ↗ ← All trials in Canada