Treatments for Depression

(AIMS Trial)

Recruiting at 2 trial locations

Overseen By Sara Sellars, M.A

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two therapy approaches to determine which is more effective for adults aged 55 and over who experience depression and have some risk of suicide. The goal is to improve symptoms such as trouble sleeping and low moods. Participants will attend weekly sessions with a therapist or health coach for eight weeks. This trial suits individuals with ongoing depression symptoms who have either suicidal thoughts or a history of suicide attempts. As an unphased trial, it offers participants the chance to contribute to valuable research that could lead to improved treatment options for depression and suicide prevention.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mindfulness-based stress reduction (MBSR) is generally safe for treating anxiety and depression. Over 200 studies have found that mindfulness therapy effectively reduces stress without major side effects. One study found that MBSR works as well as escitalopram, a common anxiety medication, for treating anxiety disorders. Participants in these studies did not report any serious negative effects, indicating that MBSR is well-tolerated. Therefore, MBSR appears to be a safe option for managing depression and related symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for depression because they focus on personalized, therapist-led sessions, which differ from traditional medication-based approaches like SSRIs and SNRIs. Unlike standard treatments that primarily target brain chemistry with drugs, these sessions may provide a more holistic approach by integrating mental health coaching and therapy. The unique aspect is the concealed nature of the interventions, which keeps participants unaware of specific treatment details, potentially minimizing bias and enhancing the validity of the results. This trial could reveal new ways to effectively manage depression without relying solely on medications.

What evidence suggests that this trial's treatments could be effective for depression?

Research has shown that mindfulness practices, such as mindfulness meditation, can significantly reduce symptoms of depression. For instance, one study found that mindfulness's positive effects on depression were similar to those of cognitive behavioral therapy (CBT). Mindfulness aids in managing depression by helping individuals better control their emotions and thoughts. Another study discovered that mindfulness not only eased depression and anxiety but also improved sleep quality. These findings suggest that mindfulness-based methods could effectively boost mood and reduce suicidal thoughts in older adults with depression. In this trial, participants will receive either a mindfulness-based intervention or a concealed control intervention to evaluate their effectiveness in treating depression. ^{1 3 6 7 8}

Who Is on the Research Team?

Stephen F Smagula, Ph.D

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5679245/

Mindfulness-Based Interventions for Anxiety and Depression The MBSR group demonstrated a pre-post treatment effect size (Cohen's d) of 1.06, which is comparable to the effect sizes seen in CBT for anxiety. These results ...

2. nature.com nature.com/articles/s41598-024-71213-9

The effect of mindfulness meditation on depressive ... The findings suggest a positive effect of mindfulness meditation on depressive symptoms in individuals with depression during the COVID-19 pandemic.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666915325000599

The efficacy of mindfulness-based cognitive therapy in ... The results support that MBCT effectively manages the symptoms of depressive disorders and regulates cognition and emotions. Conclusion. MBCT, when implemented ...

4. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1259250/full

The efficacy of mindfulness-based interventions on mental ... In our study, mindfulness therapy was found to significantly reduce depression, anxiety and stress symptoms, raise sleep quality, but it was not ...

5. apa.org apa.org/topics/mindfulness/meditation

Mindfulness meditation: A research-proven way to reduce ... Several studies have found, for example, that MBCT can significantly reduce relapse in people who have had previous episodes of major depression ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7511255/

The Effectiveness of Mindfulness-Based Stress Reduction ... The reviewed literature suggested that MBSR was effective in reducing HCPs experiences of anxiety, depression and stress.

7. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2798510

Mindfulness-Based Stress Reduction vs Escitalopram for ... This randomized clinical trial evaluates whether mindfulness-based stress reduction is noninferior to escitalopram in the treatment of anxiety disorders.

8. nature.com nature.com/articles/s44220-023-00081-5

Systematic review and individual participant data meta- ... Mindfulness-based programs (MBPs) are widely used to prevent mental ill health. Evidence suggests beneficial average effects but wide variability.