Treatments for Depression

(AIMS Trial)

Recruiting at 2 trial locations

Overseen By Daniel J Buysse, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must be taking: Antidepressants

Must not be taking: Esketamine, Ketamine

Disqualifiers: Bipolar, Psychotic, Borderline, Dementia, others

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

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

420 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multi-site randomized control trial involving people age 55+ years who have current depression symptoms plus another suicide risk indicator (either current suicidal ideation or a past history of attempt). Our goal is evaluate which of two different approaches works best to improve things like trouble sleeping, bad moods, and any suicidality. Participants will complete diagnostic interviews, self-report scales, and wear an actigraphy device for the 8 weeks starting at the baseline visit.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you have been on depression medication at an adequate dose for at least 4 weeks before joining.

What data supports the effectiveness of the treatment for depression?

Research shows that mindfulness-based therapies, like Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy, can help reduce symptoms of depression and prevent relapse. These therapies focus on increasing awareness and acceptance of the present moment, which can improve life satisfaction and reduce depressive symptoms. ^{1 2 3 4 5}

Is mindfulness meditation safe for humans?

Mindfulness meditation, including programs like Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), is generally considered safe for humans. Some people may experience anxiety or discomfort during practice, but these are often expected reactions rather than harmful effects. Severe outcomes like psychosis are rare and usually influenced by other factors such as the intensity of practice and personal mental health history. ^{6 7 8 9 10}

How does the treatment Mindfulness-Based Stress Reduction differ from other treatments for depression?

Mindfulness-Based Stress Reduction (MBSR) is unique because it uses mindfulness training to help reduce symptoms of depression, stress, and anxiety. Unlike traditional drug treatments, MBSR is a non-drug therapy that involves meditation and mindfulness practices, making it a safe, portable, and cost-effective option that can be used alongside standard care. ^{7 8 11 12 13}

Research Team

Stephen F Smagula, Ph.D

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for individuals aged 55 or older who are currently experiencing symptoms of depression and have a risk indicator for suicide, such as current suicidal thoughts or a past attempt. They must be able to complete interviews, self-reports, and wear an actigraphy device for sleep tracking over 8 weeks.

Inclusion Criteria

I have significant sleep problems.

Patient Health Questionnaire -9 score of 10 or higher

I am 55 years old or older.

Exclusion Criteria

Borderline personality disorder

Active substance use disorder of at least moderate severity

Bipolar disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete diagnostic interviews, self-report scales, and wear an actigraphy device

1 week

1 visit (in-person)

Treatment

Participants receive weekly therapy sessions for 8 weeks and complete weekly phone assessments

8 weeks

8 visits (in-person), 8 phone assessments

Post-Treatment Assessment

Participants complete assessments of sleep, mood, and health after therapy ends

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with monthly phone assessments

6 months

6 phone assessments

Treatment Details

Interventions

• Active Comparator
• Active Condition

Trial Overview The study compares two different approaches to see which one better improves sleep issues, mood, and suicidality in older adults with depression. Participants will receive either the usual treatment they would get from their healthcare provider or one of two active treatments being compared.

Participant Groups

Group I: Active Condition Experimental Treatment 2 Interventions

Participants receive eight \~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.

Group II: Concealed Control Intervention Active Control 2 Interventions

Participants receive eight \~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of California, Berkeley

Collaborator

Trials

193

Recruited

716,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Augusta University

Collaborator

Trials

219

Recruited

85,900+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

Mindfulness-Based Stress Reduction (MBSR) has been shown to improve mental health in 11 studies compared to waitlist controls or treatment as usual, demonstrating its efficacy as a therapeutic intervention.

Mindfulness-Based Cognitive Therapy (MBCT) effectively reduces the risk of depressive relapse, showing similar efficacy to treatment as usual in two studies, indicating its potential as a preventive measure for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Fjorback, LO., Arendt, M., Ornbøl, E., et al.[2022]

Mindfulness meditation, particularly through programs like Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), is widely used to treat various conditions such as stress, depression, and chronic pain, but concerns about its safety have emerged due to reported adverse events.

The viewpoint argues that many reported negative experiences during mindfulness meditation, such as anxiety or discomfort, are not true adverse events but rather expected reactions that can occur as individuals learn to manage their mental and physical states; severe outcomes like psychosis are often influenced by external factors rather than the meditation itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Are Adverse Events in Mindfulness Meditation? Binda, DD., Greco, CM., Morone, NE.[2022]

Mindfulness-based stress reduction (MBSR) has been shown to improve mental health and reduce symptoms of stress, anxiety, and depression across 31 randomized studies involving both clinical and non-clinical populations.

The implementation of MBSR in the healthcare system is recommended to be gradual, ensuring that MBSR teachers in Denmark receive adequate training and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. Fjorback, LO., Rasmussen, BH., Preuss, T.[2019]

Mindfulness-based interventions (MBIs) are effective in reducing symptom severity in major depressive disorder and lowering relapse rates during maintenance treatment, based on a review of 52 studies.

MBIs, particularly mindfulness-based stress reduction, have shown effectiveness in improving symptoms and quality of life in veterans with PTSD, and they are considered safe and cost-effective adjuncts to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. Khusid, MA., Vythilingam, M.[2018]

Mindful Mood Balance (MMB), a web-based version of Mindfulness-based Cognitive Therapy (MBCT), was effective in reducing depressive symptoms and rumination in a study of 100 recurrently depressed individuals over an 8-session program with a 6-month follow-up.

Participants using MMB showed significant improvements in depressive severity and mindfulness compared to those receiving usual depression care, indicating that web-based delivery of MBCT can be beneficial for individuals with a history of depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based Mindfulness-based Cognitive Therapy for reducing residual depressive symptoms: An open trial and quasi-experimental comparison to propensity score matched controls. Dimidjian, S., Beck, A., Felder, JN., et al.[2022]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

Mindfulness-based interventions (MBIs), such as mindfulness-based stress reduction and mindfulness-based cognitive therapy, have been shown to effectively reduce symptoms of anxiety and depression across various populations.

MBIs consistently outperform non-evidence-based treatments and are comparable in efficacy to cognitive behavior therapy (CBT), indicating their strong potential as a therapeutic option for mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Anxiety and Depression. Hofmann, SG., Gómez, AF.[2018]

Mindfulness-based cognitive therapy (MBCT) is recognized as an effective psychotherapeutic intervention that combines cognitive behavioral therapy with mindfulness meditation, specifically aimed at preventing recurrent major depressive disorder.

Over the past fifteen years, MBCT has gained significant attention and is now recommended in various national clinical guidelines for its potential to prevent depressive episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness-based cognitive therapy is efficient in the treatment of recurrent depression]. Velden, AM., Piet, J., Møller, AB., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Added value of Mindfulness-Based Cognitive Therapy for Depression: A Tree-based Qualitative Interaction Analysis. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for major depressive disorder: A comprehensive meta-analysis of randomized controlled trials. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Relapse prevention in major depressive disorder: Mindfulness-based cognitive therapy versus an active control condition. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Transdiagnostic internet-delivered CBT and mindfulness-based treatment for depression and anxiety: A randomised controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

What Are Adverse Events in Mindfulness Meditation? [2022]

7. Denmark pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. [2019]

8. England pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Web-based Mindfulness-based Cognitive Therapy for reducing residual depressive symptoms: An open trial and quasi-experimental comparison to propensity score matched controls. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Anxiety and Depression. [2018]

12. Denmark pubmed.ncbi.nlm.nih.gov

[Mindfulness-based cognitive therapy is efficient in the treatment of recurrent depression]. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Effects of Mindfulness Meditation Intervention on Depressive Symptoms in Emerging Adults: A Systematic Review and Meta-Analysis. [2022]