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

NCT07250893 | Recruiting

• 1 other identifier: 17671
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Childhood Traumas; Depression - Major Depressive Disorder

Keywords

Early life adversity; Depression; Emotional dysregulation; Childhood trauma

Outcome Measures

Primary Outcomes (1)

• Montgomery and Asberg Depression Rating Scale (MADRS)

  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.

  Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment)

Secondary Outcomes (7)

• Difficulties with Emotional Regulation Scale

  Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment)

• International Trauma Questionnaire

  Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment)

• PTSD Checklist for the DSM-5

  Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment)

• Biomarkers - Hormonal markers

  Baseline (week 0), Treatment endpoint (week 12)

• Illness Intrusiveness Scale

  Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment)

Study Arms (1)

Psychotherapy arm

EXPERIMENTAL

The psychotherapy intervention will be delivered virtually over 12 weeks, 1x/week for 1 hour, 1-on-1 with a therapist

Other: Psychotherapy

Interventions

Psychotherapy OTHER

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

Psychotherapy arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Sun Life Financial Movement Disorders Research and Rehabilitation Centre: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8P 3R2, Canada

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Benicio Frey, MD, PhD

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

• Sheryl Green, PhD

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

• Jenna Boyd, PhD

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katerina Dikaios, MSc

CONTACT

9028779750; dikaiosk@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry & Behavioural Neurosciences; Director, Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: November 26, 2025
• Study Start: October 25, 2025
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

CA (1)