Cognitive Behavioural Therapy for Depression

Overseen By Principal Investigator

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Baycrest

Must not be taking: Ketamine

Disqualifiers: PTSD, OCD, Schizophrenia, substance-use, others

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

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how Cognitive Behavioural Therapy (CBT) can improve mood and cognitive function in people with midlife depression. Researchers use brain imaging to observe how CBT affects brain connections and blood flow, which might help prevent future memory problems or dementia. Participants will receive 12 weeks of CBT and undergo several follow-up assessments. The trial seeks individuals aged 40-60 who have experienced depression for at least three months. As an unphased trial, this study offers a unique opportunity to contribute to understanding how CBT can benefit mental health and potentially prevent cognitive decline.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that Cognitive Behavioural Therapy is safe for treating midlife depression?

Research shows that Cognitive Behavioral Therapy (CBT) is generally safe and well-tolerated for treating mental health issues like depression. Many studies have found that CBT effectively reduces depression symptoms. For instance, one study found that CBT significantly lowered depression levels in adults. Another study noted that treatment guidelines for major depression recommend CBT because it works well.

CBT usually doesn't involve medication, so it often has fewer side effects than drug treatments. This makes it a good choice for people who want to avoid the side effects associated with antidepressants. So far, no major reports of negative effects from CBT itself have emerged.

Overall, existing research suggests that CBT is a safe way to manage depression for those considering joining a trial involving this therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioural Therapy (CBT) for midlife depression because it offers a non-drug approach that targets thought patterns and behaviors, unlike standard antidepressant medications. Most treatments for depression, like SSRIs or SNRIs, primarily focus on altering brain chemistry. In contrast, CBT empowers individuals by teaching them practical skills to manage their symptoms and reduce the risk of relapse. Additionally, the use of pre- and post-treatment MRI scans in this study may provide insights into how CBT physically affects brain structure, potentially paving the way for more personalized mental health care.

What evidence suggests that Cognitive Behavioural Therapy is effective for midlife depression?

Research has shown that Cognitive Behavioral Therapy (CBT) effectively treats depression and can match or surpass medication over time. Studies have found that CBT not only improves mood but also enhances thinking skills like memory and focus. For people with depression, CBT leads to fewer relapses compared to usual treatments. This therapy is especially promising because it addresses both mood and cognitive issues, common in middle-aged adults with depression. Overall, CBT is a strong option for managing depression-related cognitive issues. Participants in this trial will undergo 12 weeks of CBT, with additional follow-up assessments and clinical evaluations to further explore its benefits. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing major depressive disorder (MDD) in midlife, who may have cognitive impairments. The study seeks participants willing to undergo Cognitive Behavioural Therapy (CBT) and neuroimaging tests. Specific eligibility criteria are not provided.

Inclusion Criteria

I have been diagnosed with Major Depressive Disorder.

I have mild or more severe depression, scored 7 or higher on the MADRS.

I can follow the study's requirements as determined by the researchers.

Exclusion Criteria

Presence of comorbid post-traumatic stress disorder, obsessive-compulsive disorder, eating disorder(s), schizophrenia, or other psychiatric disorders

I have had a brain injury, stroke, seizures, or brain surgery.

Contraindications to magnetic resonance imaging (MRI) scanning

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 weeks of Cognitive Behavioural Therapy (CBT) with pre- and post-treatment MRI assessments

12 weeks

Weekly CBT sessions, 2 MRI visits (pre and post-treatment)

Follow-up

Participants are monitored for safety and effectiveness after treatment with three follow-up assessments

4 weeks

3 follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioural Therapy

Trial Overview The trial aims to assess the impact of CBT on mood and cognitive function in those with midlife depression using advanced brain imaging techniques to observe changes in neural connectivity and vascular health.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

Individuals with midlife depression (MDD, ages 40-60 years) will undergo 12 weeks of CBT, in addition to three follow-up assessments, clinical evaluation (including completion of self-report and clinician-rated questionnaires) and pre-post CBT magnetic resonance imaging (MRI).

Who Is Running the Clinical Trial?

Baycrest

Lead Sponsor

Trials

46

Recruited

6,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9840507/

Cognitive behavior therapy vs. control conditions, other ... CBT appears to be as effective as pharmacotherapies at the short term, but more effective at the longer term. Keywords: Depression, cognitive ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165032725006433

Review Article Are cognitive behavioural therapy ... CBT has been found to be significantly more effective than treatment as usual (TAU) and at least as effective as other therapies (Cuijpers and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3584580/

The Efficacy of Cognitive Behavioral Therapy: A Review ... Results suggested that compared to control treatment, CBT plus standard maintenance was more efficacious in terms of leaving the study early and cocaine use for ...

4. nature.com nature.com/articles/s41746-022-00677-8

A systematic review of digital and face-to-face cognitive ... Since its emergence nearly fifty years ago, a large number of studies has underlined the effectiveness of CBT in improving depressive symptoms, ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2788926

Effect of Computer-Assisted Cognitive Behavior Therapy vs ... In this randomized clinical trial of 175 adults, CCBT reduced depression, as measured by the Patient Health Questionnaire–9, to a significantly greater extent ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489050/

Cognitive–behavioral therapy for management of mental ... The results of several randomized controlled trials indicated that CBT was effective for a variety of mental problems (e.g., anxiety disorder, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0165032725012339

Cognitive behavioral therapies are evidence-based – ... With this paper, we wanted to review all outcomes evaluated in recent RCTs of CBTs for depression and quantify the effects obtained.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11943665/

Next-Generation Cognitive-Behavioral Therapy for Depression CBT is now the dominant therapy for depressive disorders and is also generally recommended in treatment guidelines for patients with major depression [20,21].

9. sciencedirect.com sciencedirect.com/science/article/pii/S0887618524000379

Outcomes of transdiagnostic internet-delivered cognitive ... Transdiagnostic online therapy was tailored to public safety personnel (PSP). PSP showed good treatment satisfaction, course completion, and symptom reduction.