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

NCT07250893 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-03

No results posted yet for this 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.

Conditions

  • Depression - Major Depressive Disorder
  • Childhood Traumas

Interventions

OTHER

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

Sponsors & Collaborators

  • Sun Life Financial Movement Disorders Research and Rehabilitation Centre

    collaborator OTHER

  • St. Joseph's Healthcare Hamilton

    lead OTHER

Principal Investigators

  • Benicio Frey, MD, PhD · St. Joseph's Healthcare Hamilton

  • Sheryl Green, PhD · St. Joseph's Healthcare Hamilton

  • Jenna Boyd, PhD · St. Joseph's Healthcare Hamilton

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-25
Primary Completion
2027-08-15
Completion
2028-08-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07250893 on ClinicalTrials.gov