Testing Psychotherapy for depression - major depressive disorder
Official title: Resolving Early Life Stress: Psychotherapy Outcomes and Neurobiology in Complex Depression
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
Canadian Sites (1)
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Eligibility Criteria
See who this study is looking for8 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- −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)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Psychotherapy.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 65 years.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 50 people.
The study is currently expected to finish around August 2028.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (week 0), Treatment endpointEndpointThe specific thing a study measures to answer its question.Read more → (week 12), Follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → (3 months post treatment).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Montgomery and Asberg Depression Rating Scale (MADRS) — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (week 0), Treatment endpointEndpointThe specific thing a study measures to answer its question.Read more → (week 12), Follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → (3 months post treatment).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07250893 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PsychotherapyOther
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
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 65 years.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (week 0), Treatment endpointEndpointThe specific thing a study measures to answer its question.Read more → (week 12), Follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → (3 months post treatment).
The study as a whole is currently expected to finish around 2028-08-15.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 50 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Hamilton, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.