Virtual Mindfulness-Based Intervention for Depression

(RECLAIM Trial)

Overseen By Ai-Nghia L Do, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

37 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test a mindfulness-based intervention to reduce depressive symptoms and improve Veterans' community reintegration.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the study team or your healthcare provider for guidance.

What data supports the idea that Virtual Mindfulness-Based Intervention for Depression (also known as: RECLAIM) is an effective treatment?

The available research shows that web-based Mindfulness-Based Cognitive Therapy (MBCT), like the Mindful Mood Balance program, significantly reduces depression symptoms and helps prevent relapse. In a study, participants who used this online approach showed a decrease in depression severity that lasted for six months. They also experienced less rumination, which means they spent less time dwelling on negative thoughts. Compared to those receiving usual depression care, the online MBCT group had better outcomes. Another study found that using a mindfulness app with clinician support led to a noticeable reduction in depression symptoms, suggesting that virtual mindfulness interventions can be effective and accessible alternatives to traditional treatments. ^{1 2 3 4 5}

What safety data exists for virtual mindfulness-based interventions for depression?

The safety data for virtual mindfulness-based interventions, such as Mindful Mood Balance (MMB), indicates that these interventions are generally safe and effective. In a study with 100 participants, MMB showed significant reductions in depressive severity and improvements in rumination and mindfulness, sustained over six months. The study noted limitations like non-randomized design and short follow-up, but it supports the web-based delivery of MBCT. Another study involving 1554 participants in real-world settings found that MBCT was delivered effectively and safely, with a low rate of reliable deterioration (3%), comparable to other psychotherapeutic interventions. However, there is limited research on adverse effects, and more studies are needed to fully understand the safety profile of these interventions. ^{1 2 6 7 8}

Is the treatment in the trial 'Virtual Mindfulness-Based Intervention for Depression' a promising treatment?

Yes, the treatment is promising. Online mindfulness-based interventions, like Mindful Mood Balance, have been shown to reduce depressive symptoms and improve mindfulness and rumination. They are accessible and can be effective for people with depression, including those who haven't responded to other treatments. ^{1 3 9 10 11}

Research Team

Sarah A Shue, PhD MS BA

Principal Investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Eligibility Criteria

This trial is for Veterans enrolled in VHA care, aged 18-44, who served after October 2001 and are experiencing difficulty adjusting to civilian life. They must also have moderate depression as indicated by a score of 10-14 on the PHQ-9.

Inclusion Criteria

Veteran participants must endorse at least a moderate level of depression as defined by a PHQ-9 score of 10-14

Veteran participants must have served active duty and/or in the National Guard/Reserves after October 2001

I am a veteran aged between 18 and 44.

Exclusion Criteria

Veterans will not be immediately excluded from participation in the study; the study team will consult with the Roudebush Suicide Prevention Team and/or the Veterans' care provider to determine whether continued study participation is appropriate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RECLAIM intervention, a virtual mindfulness-based program, over eight weekly sessions

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment using various questionnaires

4 weeks

Qualitative Interviews

A subgroup of participants engages in qualitative interviews to assess the acceptability of the RECLAIM intervention

Treatment Details

Interventions

• RECLAIM

Trial Overview The study tests 'RECLAIM', a virtual mindfulness-based program designed to ease depressive symptoms and help Veterans reintegrate into civilian life more smoothly.

Participant Groups

Group I: RECLAIM intervention Experimental Treatment 1 Intervention

Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting.

Group II: Psychoeducation materials only Active Control 1 Intervention

We will use a psychoeducation-only control group. They will only receive psychoeducational materials (e.g., suggested readings, podcasts, blogs). These are the same materials that the intervention arm participants will receive.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

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 of 274 participants with a history of recurrent major depressive disorder, mindfulness-based cognitive therapy (MBCT) did not significantly reduce the overall risk of relapse compared to cognitive psychological education (CPE) or treatment as usual (TAU) over a 12-month follow-up period.

However, MBCT was particularly beneficial for individuals with a history of childhood trauma, showing a significant reduction in relapse risk compared to TAU and CPE for those with higher trauma severity, indicating that MBCT may be more effective for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for preventing relapse in recurrent depression: a randomized dismantling trial. Williams, JM., Crane, C., Barnhofer, T., et al.[2022]

A mixed-methods feasibility study involving 54 participants showed that a blended intervention using the mindfulness app Headspace with clinician support is feasible and acceptable for treating moderate to moderately severe depression.

Participants who engaged more with the Headspace sessions experienced a significant reduction in depression symptoms, with a notable effect size of d = 0.69, indicating potential effectiveness, though further research is needed to confirm these findings and explore long-term impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is clinician-supported use of a mindfulness smartphone app a feasible treatment for depression? A mixed-methods feasibility study. Strauss, C., Dunkeld, C., Cavanagh, K.[2021]

Mindfulness-based Cognitive Therapy (MBCT) appears to be a promising and cost-effective intervention for older adults with a history of relapsing major depression, based on a study involving 38 participants aged over 65, with 30 completing the course.

Participants reported that MBCT was helpful in managing their depression, suggesting that it could be a valuable addition to treatment options for older individuals, although further research is needed to refine the approach for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for recurring depression in older people: a qualitative study. Smith, A., Graham, L., Senthinathan, S.[2020]

Mindfulness-Based Cognitive Therapy (MBCT) is as effective as Cognitive Behaviour Therapy (CBT) for treating non-melancholic depression, based on an 8-week study with 45 participants.

Participants with a history of four or more depressive episodes showed greater improvement in depression scores with CBT compared to those with fewer episodes, indicating that CBT may be particularly beneficial for individuals with recurrent depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy vs cognitive behaviour therapy as a treatment for non-melancholic depression. Manicavasgar, V., Parker, G., Perich, T.[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]

In a 21-day mindfulness-based intervention with 82 participants, 87% reported at least one momentary adverse effect during meditation, primarily anxiety, indicating that mindfulness practice can sometimes lead to temporary increases in anxiety.

Despite these momentary effects, 25% of participants experienced sustained adverse effects in daily life after the intervention, but these were not linked to the momentary effects during meditation, suggesting that increased awareness of internal states may contribute to these post-intervention challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. Aizik-Reebs, A., Shoham, A., Bernstein, A.[2021]

In a study involving 1554 participants across five UK mental health services, mindfulness-based cognitive therapy (MBCT) was found to be effective in preventing depressive relapse, with 96% of those who entered treatment in the non-depressed range maintaining their recovery.

For participants who entered with current depression, 45% achieved recovery, and there was a significant reduction in overall depression severity, indicating that MBCT is being delivered safely and effectively in real-world settings, even beyond its original target population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Real-World Healthcare Services. Tickell, A., Ball, S., Bernard, P., et al.[2021]

Online mindfulness-based interventions (MBIs) significantly improved depressive symptoms in college and university students, with a moderate effect size of 0.18 based on a systematic review of 15 studies involving 1886 participants.

The effectiveness of online MBIs was influenced by factors such as the timing of depression measurement after the intervention and the attrition rates of participants, suggesting that careful study design can enhance the outcomes of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Online Mindfulness-Based Interventions on Depressive Symptoms in College and University Students: A Systematic Review and Meta-Analysis. Reangsing, C., Abdullahi, SG., Schneider, JK.[2023]

Mindfulness-Based Cognitive Therapy (MMB) significantly reduced suicidal ideation in patients with a history of suicide attempts or current suicidal thoughts, showing a moderate effect size in a study of 109 participants.

MMB also contributed to a decrease in overall depression severity among this high-risk group, suggesting that digital interventions can effectively support traditional depression care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of online Mindfulness-Based Cognitive Therapy on suicidal ideation: A secondary analysis of a randomized trial of Mindful Mood Balance. Dimidjian, S., Kaufman, J., Coleman, N., et al.[2022]

Mindfulness-based Cognitive Therapy (MBCT) was found to be acceptable for patients currently experiencing major depression who had not fully responded to standard treatments, indicating its potential as an alternative intervention.

The therapy led to a significant improvement in depression scores, with a pre-post effect size of 1.04, suggesting that many participants experienced a return to normal or near-normal mood levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment-resistant depressed patients show a good response to Mindfulness-based Cognitive Therapy. Kenny, MA., Williams, JM.[2022]

References

1. 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]

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

Mindfulness-based cognitive therapy for preventing relapse in recurrent depression: a randomized dismantling trial. [2022]

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

Is clinician-supported use of a mindfulness smartphone app a feasible treatment for depression? A mixed-methods feasibility study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for recurring depression in older people: a qualitative study. [2020]

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

Mindfulness-based cognitive therapy vs cognitive behaviour therapy as a treatment for non-melancholic depression. [2022]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. [2021]

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

The Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Real-World Healthcare Services. [2021]

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

Effects of Online Mindfulness-Based Interventions on Depressive Symptoms in College and University Students: A Systematic Review and Meta-Analysis. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of online Mindfulness-Based Cognitive Therapy on suicidal ideation: A secondary analysis of a randomized trial of Mindful Mood Balance. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Treatment-resistant depressed patients show a good response to Mindfulness-based Cognitive Therapy. [2022]