Psychotherapy for Depression

(RESPOND Trial)

Overseen By Katerina Dikaios, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: St. Joseph's Healthcare Hamilton

Disqualifiers: PTSD, Mania, Psychosis, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of psychotherapy designed to help individuals who have faced challenging early-life experiences and now struggle with depression. The trial aims to determine if this therapy can improve symptoms such as low mood and emotional distress. Researchers are also examining how these early life challenges might affect the body and whether the therapy can address these changes. Suitable candidates for this trial include adults with moderate to severe depression who experienced difficult situations before age 18. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to new therapeutic approaches for depression.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this psychotherapy is safe for treating depression?

Research has shown that psychotherapy is a safe and effective treatment for depression. Therapy participants are less likely to experience new episodes of depression over time. For instance, one study found that therapy significantly reduced the likelihood of a new depressive episode at 12 and 24 months compared to those without therapy. Another study showed that about one-third of patients improved after therapy, a much higher rate than those who did not receive treatment.

Overall, most people find psychotherapy manageable. It does not involve medication, so it typically has fewer side effects than drug treatments, making it a good option for those concerned about medication side effects. While therapy might not work for everyone, it generally offers a safe and supportive way to address depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this psychotherapy treatment for depression because it offers a unique delivery method. Unlike traditional face-to-face therapy sessions, this treatment is delivered virtually in group settings. This approach not only makes therapy more accessible by eliminating the need for travel but also provides a supportive environment where participants can share experiences and gain insights from each other. Moreover, the structured 12-week program, with weekly two-hour sessions, is designed to foster consistent engagement and potentially enhance therapeutic outcomes.

What evidence suggests that this psychotherapy is effective for depression?

Research has shown that talking therapies, such as psychotherapy, effectively treat depression. Studies have found that psychotherapy can lift mood, help manage emotions, and reduce troubling thoughts. It can work as well as medication and sometimes even better when combined with it. Different types of psychotherapy, such as cognitive behavioral therapy (CBT) and interpersonal therapy, have proven effective for people with depression. In this trial, the psychotherapy intervention targets symptoms related to difficult early life experiences, aiming to improve well-being by focusing on those specific issues. ^{1 2 3 4 6}

Who Is on the Research Team?

Sheryl Green, PhD

Principal Investigator

St. Joseph's Healthcare Hamilton

Benicio Frey, MD, PhD

Principal Investigator

St. Joseph's Healthcare Hamilton

Jenna Boyd, PhD

Principal Investigator

St. Joseph's Healthcare Hamilton

Are You a Good Fit for This Trial?

This trial is for individuals who have depression linked to early life stress or trauma. Participants should be experiencing symptoms like low mood, emotional instability, and distressing thoughts due to past difficult experiences. Specific eligibility details are not provided.

Inclusion Criteria

At or above 18 on HAM-D, indicative of moderate-severe depressive symptoms

I am 18 years old or older.

I have experienced significant challenges or trauma in my childhood.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person or virtual)

Baseline

Diagnostic interview, blood collection, demographics, and clinical measures administered

1 week

1 visit (in-person)

Treatment

Participants receive psychotherapy intervention virtually in a group format, 1x/week for 12 weeks

12 weeks

12 visits (virtual)

Treatment Endpoint

Blood collected and clinical measures administered

1 week

1 visit (in-person)

Follow-up

Clinical measures administered to monitor changes post-treatment

3 months

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Psychotherapy

Trial Overview

The RESPOND trial is testing a new psychotherapy designed for those affected by childhood adversity. It aims to improve depressive symptoms and emotional regulation while also examining biological changes through health questionnaires and blood tests.

How Is the Trial Designed?

Group I: Psychotherapy arm Experimental Treatment 1 Intervention

The psychotherapy intervention will be delivered virtually over 12 weeks, 1x/week for 2 hours, in groups of 6-8 participants.

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Collaborator

Trials

10

Recruited

510+

Citations

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samhsa.gov/

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SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5709536/

Psychotherapy for Major Depressive Disorder and ...

Three commonly used psychological interventions are cognitive behavioural therapy (CBT), interpersonal therapy, and supportive therapy.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0165032723006389

Psychological treatment of depression: A systematic ...

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4.

frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1415905/full

Enduring effects of psychotherapy, antidepressants and ...

Current findings suggest a superiority of psychotherapy and combined treatment over pharmacotherapy alone in major depressive disorder depression.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5244449/

The efficacy of psychotherapy, pharmacotherapy and their ...

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uptodate.com

uptodate.com/contents/major-depressive-disorder-in-adults-approach-to-initial-management

Major depressive disorder in adults: Approach to initial ...

Overall outcomes – Psychotherapy is efficacious for the initial treatment of MDD [130-132]. Multiple meta-analyses suggest that it is superior ...