RecruitingNot ApplicableNCT07250893

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

Sponsor

St. Joseph's Healthcare Hamilton

Enrollment

50 participants

Start Date

Oct 25, 2025

Study Type

INTERVENTIONAL

Conditions

Depression - Major Depressive Disorder Childhood Traumas

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: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a type of psychotherapy called RELATE (Resolving Early Life Adversity Through Empathic Engagement) for adults with moderate-to-severe depression who experienced difficult childhood events (such as abuse or neglect). It aims to understand both the psychological benefits and the brain changes that occur through this treatment. **You may be eligible if...** - You are 18 or older - You have moderate to severe depression symptoms - You experienced at least one adverse childhood event (such as abuse, neglect, or difficult family circumstances) before the age of 18 - You are not currently in regular psychotherapy **You may NOT be eligible if...** - Your trauma is from a single adult event (and you have no childhood adversity history) - You currently have active mania or psychosis - You have an active substance use disorder - You have active suicidal thoughts with a plan and intent - You have been consistently engaged in psychotherapy in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPsychotherapy

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