Mindful Self-Compassion for Anxiety and Depression

Overseen By Charisma, Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgetown University

Must not be taking: Barbiturates, Antipsychotics

Disqualifiers: Psychotic disorder, OCD, Bipolar, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial allows some psychiatric medications, like certain sleep medications and anti-depressants, if you've been on a stable dose for at least 8 weeks before starting and plan to continue at the same dose during the trial. However, medications like barbiturates or antipsychotics are not allowed.

What data supports the effectiveness of the treatment Mindful Self-Compassion for Anxiety and Depression?

Research shows that mindfulness and self-compassion training can reduce symptoms of depression and anxiety. Studies found that these practices help increase self-compassion and mindfulness, which are linked to better mental health outcomes. ^{1 2 3 4 5}

Is Mindful Self-Compassion safe for humans?

Research on Mindful Self-Compassion and related practices like Mindfulness Meditation and Compassion Focused Therapy suggests they are generally safe for humans, with studies showing benefits like reduced anxiety and depression without reporting significant adverse effects. ^{2 4 5 6 7}

How does the Mindful Self-Compassion treatment differ from other treatments for anxiety and depression?

Mindful Self-Compassion (MSC) is unique because it combines mindfulness meditation with self-compassion training, focusing on self-kindness, common humanity, and mindfulness to help individuals relate to painful experiences. Unlike other treatments, MSC is an 8-week program that includes meditations and informal practices like soothing touch and self-compassionate letter writing, aiming to cultivate self-compassion and improve emotional regulation. ^{1 3 4 5 8}

What is the purpose of this trial?

The study will compare 8-week Mindful Self-Compassion training, compared to a control group that does not receive the intervention, on anxiety and depression symptom severity in patients with diagnosed anxiety disorders (generalized anxiety disorder, social anxiety disorder, and panic disorder) or major depressive disorder.

Research Team

Elizabeth Hoge, MD

Principal Investigator

Georgetown University

Eligibility Criteria

This trial is for adults with anxiety disorders (like social anxiety, generalized anxiety, panic disorder, or agoraphobia) or major depression who feel they aren't very self-compassionate. Participants must understand the study and agree to all parts of it. People can't join if they've had certain mental health treatments recently, have severe medical conditions that could interfere, are pregnant, prisoners, or plan to be away during the study.

Inclusion Criteria

I can understand and agree to the study's procedures.

Must score low on self-compassion, as measured by the self-compassion scale

Must understand study procedure and willing to participate in all testing visits, and treatment as assigned

Exclusion Criteria

Pregnant women

I have had serious thoughts or actions of suicide in the last year.

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mindful Self-Compassion training in weekly classes for 8 weeks

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mindful Self-Compassion

Trial Overview The trial tests an 8-week Mindful Self-Compassion program against a control group not receiving this training. It aims to see if this approach helps reduce symptoms of anxiety and depression in participants compared to those who don’t receive the intervention.

Participant Groups

Group I: Mindful Self-Compassion Experimental Treatment 1 Intervention

Mindful Self-Compassion (MSC) is a weekly class given for 8 weeks. The individual classes last about 2 hours each. The class is provided in a group setting.

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

The TAU arm will not receive the additional treatment from the study. Subjects will receive psychiatric treatment from their usual providers.

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

Findings from Research

Mindfulness-Based Compassionate Living (MBCL) was found to be feasible and acceptable for adults with recurrent depression, with no dropouts and high attendance rates (average 7.52 out of 8 sessions) during the intervention.

Preliminary results indicated that while the second group showed a reduction in depressive symptoms and an increase in self-compassion, the first group did not experience significant changes, highlighting the need for further research in a larger, randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Co-creation and Feasibility of a Compassion Training as a Follow-up to Mindfulness-Based Cognitive Therapy in Patients with Recurrent Depression. Schuling, R., Huijbers, M., Jansen, H., et al.[2020]

The online compassion-focused intervention, mindfulness-based compassionate living (MBCL), significantly reduced depressive and anxiety symptoms and increased self-compassion in 122 participants over 8 weeks, with medium to large effect sizes.

These positive effects were maintained for 6 months after the intervention, indicating that MBCL can be an effective long-term strategy for individuals with high self-criticism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Based Compassion-Focused Intervention for Increased Self-Criticism: A Randomized Controlled Trial. Krieger, T., Reber, F., von Glutz, B., et al.[2019]

In a pilot study of 11 patients with chronic depression, a 12-week program combining mindfulness and compassion exercises significantly reduced depression severity, with improvements continuing at a 3-month follow-up.

The treatment led to better emotion regulation, including increased acceptance of emotions and decreased rumination, suggesting that mindfulness and compassion practices could enhance therapeutic options for chronic depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 12-Week Mindfulness, Compassion, and Loving Kindness Program on Chronic Depression: A Pilot Within-Subjects Wait-List Controlled Trial. Graser, J., Höfling, V., Weβlau, C., et al.[2020]

Self-compassion, which includes self-kindness, common humanity, and mindfulness, is linked to better mental health and less psychological distress, highlighting its importance in emotional well-being.

The Mindful Self-Compassion (MSC) program, an 8-week course with weekly sessions, effectively teaches participants to develop self-compassion through various meditative and practical exercises, demonstrating its potential as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-compassion in clinical practice. Germer, CK., Neff, KD.[2013]

Both Mindfulness-Based Cognitive Therapy (MBCT) and Compassion-Focused Therapy (CFT) significantly improved self-compassion, mindfulness, and reduced symptoms of rumination, depression, anxiety, and stress in a pilot study of 58 participants.

CFT was particularly effective in enhancing mindfulness for all participants, while MBCT specifically benefited those with high levels of rumination, indicating that both therapies can be effective in different ways depending on individual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Mindfulness Based Cognitive Therapy (MBCT) and Compassion Focused Therapy (CFT) on Symptom Change, Mindfulness, Self-Compassion, and Rumination in Clients With Depression, Anxiety, and Stress. Frostadottir, AD., Dorjee, D.[2020]

A loving-kindness meditation (LKM) program significantly reduced self-criticism and depressive symptoms while increasing self-compassion and positive emotions in a study of 38 self-critical individuals.

These benefits were maintained three months after the intervention, suggesting that LKM may be an effective long-term strategy for improving mental health in self-critical individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A wait-list randomized controlled trial of loving-kindness meditation programme for self-criticism. Shahar, B., Szsepsenwol, O., Zilcha-Mano, S., et al.[2022]

A short-term online Compassion Mind Training (CMT) program significantly reduced self-criticism in participants, with effects lasting for at least two months after the intervention.

The study involved 144 participants, and while self-criticism decreased, there was no significant change in self-reassurance or self-compassion, indicating that CMT specifically targets self-critical thoughts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised Controlled Trial of an Online Version of Compassion Mind Training in a Nonclinical Sample. Halamová, J., Kanovský, M., Pačutová, A., et al.[2021]

Dispositional mindfulness (DM) and self-compassion (SC) were found to be protective factors against symptoms of depression and anxiety during the COVID-19 pandemic, with significant negative correlations to COVID-19-related stress and fears across two studies involving 888 participants.

Self-compassion specifically moderated the relationship between COVID-19 fears and emotional impacts on psychological symptoms, while different measures of mindfulness showed varying effectiveness, indicating that certain mindfulness assessments may be more beneficial in understanding these relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dispositional Mindfulness and Self-Compassion Buffer the Effects of COVID-19 Stress on Depression and Anxiety Symptoms. Beshai, S., Salimuddin, S., Refaie, N., et al.[2022]

References

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

The Co-creation and Feasibility of a Compassion Training as a Follow-up to Mindfulness-Based Cognitive Therapy in Patients with Recurrent Depression. [2020]

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

An Internet-Based Compassion-Focused Intervention for Increased Self-Criticism: A Randomized Controlled Trial. [2019]

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

Effects of a 12-Week Mindfulness, Compassion, and Loving Kindness Program on Chronic Depression: A Pilot Within-Subjects Wait-List Controlled Trial. [2020]

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

Self-compassion in clinical practice. [2013]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Mindfulness Based Cognitive Therapy (MBCT) and Compassion Focused Therapy (CFT) on Symptom Change, Mindfulness, Self-Compassion, and Rumination in Clients With Depression, Anxiety, and Stress. [2020]

6. England pubmed.ncbi.nlm.nih.gov

A wait-list randomized controlled trial of loving-kindness meditation programme for self-criticism. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Randomised Controlled Trial of an Online Version of Compassion Mind Training in a Nonclinical Sample. [2021]

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

Dispositional Mindfulness and Self-Compassion Buffer the Effects of COVID-19 Stress on Depression and Anxiety Symptoms. [2022]