Resolving Early Life Stress: Psychotherapy Outcomes and Neurobiology in Complex Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorSt. Joseph's Healthcare Hamilton
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Psychotherapy
Other interventionSession 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
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Psychotherapy armExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment)Secondary outcomes
1
Difficulties with Emotional Regulation Scale
The Difficulties with Emotional Regulation Scale is a self-report measure used to assess emotional regulation difficulties over multiple domains (Gratz \& Roemer, 2004). It is a transdiagnostic measure appropriate for measuring changes in emotional regulation over time.
Time frame
Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment)2
International Trauma Questionnaire
The International Trauma Questionnaire is a self-report measure designed to assess and diagnose PTSD and complex PTSD in accordance with criteria from the ICD-11 (Cloitre, 2020; Cloitre et al., 2018). The questionnaire also measures symptom severity for PTSD and cPTSD symptom clusters. It is the only self-report measure designed to diagnose ICD-11 cPTSD.
Time frame
Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment)3
PTSD Checklist for the DSM-5
The PTSD Checklist for the DSM-5 is a self-report measure used to assess the severity of PTSD symptoms as identified by the DSM-5 (American Psychiatric Association, 2013; Blevins et al., 2015). The measure is appropriate for evaluating treatment progress and changes in PTSD symptoms over time.
Time frame
Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment)4
Biomarkers - Hormonal markers
Neurosteroid markers in the allopragnanolone pathway
Time frame
Baseline (week 0), Treatment endpoint (week 12)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Joseph's Healthcare Hamilton
Lead sponsor
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Collaborator
Source ClinicalTrials.gov