Recruiting

Psychological Therapy

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT07250893

Conditions

Depression - Major Depressive Disorder

Childhood Traumas

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Psychotherapy

Study Details

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

Depression - Major Depressive Disorder

Childhood Traumas

Study ID

NCT07250893

Start date

Oct 25, 2025

Status verified date

Jul, 2026

Completion date

Aug 15, 2028

Anticipated

Primary completion date

Aug 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Psychotherapy arm

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

Interventions

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

Primary outcome measure

  • Montgomery and Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment) ]

Central Contacts and Locations

Central contacts

Katerina Dikaios, MSc

905 522 1155dikaiosk@mcmaster.ca

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8P 3R2

Contacts

Katerina Dikaios, MSc.

9028779750dikaiosk@mcmaster.ca

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Early life adversity
  • Depression
  • Emotional dysregulation
  • Childhood trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2026-07-14.