Savoring Intervention for Inflammation

(SAVOR Trial)

Overseen By Julienne Bower

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Bupropion, Dopaminergic, Neuroleptics, SSRIs

Disqualifiers: Asthma, Autoimmune, Cancer, Diabetes, others

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

Compensation: Varies

Number of Visits: 8

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to evaluate how savoring influences reward and threat processes and downstream inflammation. Savoring is designed to enhance positive affect, which may blunt stress responses and reduce downstream inflammation. The investigators aim to examine changes in the brain following the savoring intervention. The investigators are particularly interested in changes in brain activity that are correlated with changes in inflammation-related markers in the blood. In this single-armed pilot trial, the investigators will assess how savoring alters reactivity to rewarding and threatening experiences, and then examine related changes in downstream inflammation. The investigators intend to recruit 20 undergraduate students to complete a 7-week standardized savoring intervention. Participants will complete brain scans, daily diaries, questionnaires, a behavioral task, and blood collection at pre- and post-intervention assessments.

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

Yes, you may need to stop taking certain medications. The trial excludes participants who have used medications that influence inflammation in the last 6 months, bupropion, dopaminergic or neuroleptic medications in the last 6 months, and those currently using heterocyclics and SSRIs unless stabilized for at least 3 months.

What data supports the idea that Savoring Intervention for Inflammation is an effective treatment?

The available research shows that incorporating savoring into mindfulness-based interventions can improve outcomes related to positive feelings and well-being, especially in treating addiction. This suggests savoring might help reduce cravings, which is important for managing addiction. Additionally, mindfulness practices, including savoring, have shown promise in improving emotional balance and eating regulation, as seen in studies on mindful eating. These findings indicate that savoring interventions can be effective in enhancing overall well-being and self-regulation. ^{1 2 3 4 5}

What safety data exists for the Savoring Intervention treatment?

The provided research does not directly address safety data for the Savoring Intervention or related mindfulness-based interventions. The studies focus on the potential benefits and mechanisms of mindfulness and savoring practices, particularly in relation to addiction, weight management, and emotional well-being. However, they do not provide specific safety data or report on adverse effects related to these interventions. ^{1 2 5 6 7}

Is the Savoring Intervention a promising treatment for inflammation?

The Savoring Intervention, which helps people focus on and enjoy positive experiences, shows promise in improving well-being and resilience in older adults. It has also been effective in boosting happiness and reducing depressive symptoms. While the research doesn't directly link it to reducing inflammation, its positive effects on mental health suggest it could be a valuable treatment for overall well-being. ^{8 9 10 11 12}

Eligibility Criteria

This trial is for undergraduate students who may be experiencing inflammation and depression. They will participate in a savoring intervention designed to enhance positive feelings and potentially reduce stress-related inflammation.

Inclusion Criteria

My depression score is moderate, between 9 and 15.

English speaking

Willingness to refrain from starting other psychosocial/pharmacological treatments until study completion

Exclusion Criteria

MRI contraindications (left-handedness, claustrophobia, colorblindness, pregnancy, metal implants, and BMI above 35)

I have a condition like asthma, autoimmune disease, or gum disease that can cause inflammation.

I have a serious medical condition like heart problems or diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Savoring Intervention

Participants undergo a 7-week savoring intervention designed to enhance positive affect and reduce inflammation

7 weeks

7 sessions (in-person)

Follow-up

Participants are monitored for changes in inflammation and psychological wellbeing post-intervention

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• Savoring Intervention

Trial Overview The study tests a savoring intervention over 7 weeks, aiming to see if it can boost positive emotions and lower stress responses that lead to inflammation. Participants will undergo brain scans, keep daily diaries, fill out questionnaires, perform a behavioral task, and give blood samples before and after the program.

Participant Groups

Group I: Savoring intervention Experimental Treatment 1 Intervention

7 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Network for Emotional Wellbeing

Collaborator

Trials

1

Recruited

20+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

Incorporating savoring into mindfulness-based interventions (MBIs) can enhance positive feelings and well-being, suggesting it may improve reward processing outcomes.

Savoring may also play a crucial role in treating addiction by potentially reducing cravings, linking it to various neurobiological theories of addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and Savoring: A Commentary on Savoring Strategies and Their Implications for Addiction Treatment. Bryan, MA., Mallik, D., Cochran, G., et al.[2022]

In a study of 63 treatment-seeking adults with overweight/obesity, specific mindfulness facets were found to correlate with emotional eating behaviors, indicating that mindfulness can play a role in managing emotional eating.

Higher levels of 'describe' mindfulness were linked to lower emotional eating related to anger and anxiety, while 'non-reactive' and 'non-judgment' mindfulness were associated with reduced emotional eating due to depression, suggesting that mindfulness training could be beneficial in addressing different emotional triggers for eating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness facets differentially relate to self-reported negative and positive emotional eating types in treatment-seeking adults with overweight/obesity. Barnhart, WR., Kalantzis, MA., Braden, AL.[2023]

Mindful eating (ME) has been shown to be more effective than generic mindfulness in predicting maladaptive eating behaviors, such as emotional and uncontrolled eating, as well as the consumption of energy-dense foods, based on a study of 292 participants.

The subfacet 'non-reactive stance' of mindful eating was particularly influential in reducing these maladaptive behaviors, suggesting that specific aspects of ME should be targeted in future mindfulness-based interventions for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking a closer look at mindful eating: incremental validity and importance of subfacets. Peitz, D., Warschburger, P.[2023]

The Mindfulness-Based Eating Awareness Training (MB-EAT) program significantly improved spiritual well-being and emotional adjustment in participants with obesity, including those with binge eating disorder, as evidenced by a study of 117 individuals.

Participants in the MB-EAT program showed stable increases in spiritual well-being, which were linked to better eating regulation and emotional balance, highlighting the program's effectiveness in fostering a healthier relationship with food and self.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindful Eating: Connecting With the Wise Self, the Spiritual Self. Kristeller, JL., Jordan, KD.[2020]

A mindfulness-based intervention for adolescents at risk of excess weight gain was found to be feasible and acceptable, with high attendance and positive feedback from participants.

While the mindfulness group showed a significant reduction in food reward sensitivity after six months, there were no significant differences in BMI or body fat changes compared to the health education control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based group intervention in adolescents at-risk for excess weight gain: A randomized controlled pilot study. Shomaker, LB., Berman, Z., Burke, M., et al.[2023]

In a study involving 54 adolescents at risk for excess weight gain, those who participated in a 6-week mindfulness-based intervention (MBI) showed a significant reduction in stress-eating compared to a health education control group over a 1.5-year follow-up.

The MBI group experienced a decrease in stress-eating, while the health education group had a notable increase, suggesting that mindfulness practices may help stabilize eating behaviors and prevent weight gain in at-risk youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based intervention in adolescents at risk for excess weight gain: 1.5-year follow-up of pilot randomized controlled trial. Bernstein, R., Sanchez, N., Clark, ELM., et al.[2022]

A mindfulness-based intervention for obesity significantly improved positive emotions and reduced anxiety and depressive symptoms over an 18-month period in adults with obesity, compared to a standard diet-exercise program.

Increases in mindfulness were linked to better psychological outcomes, suggesting that mindfulness training can enhance emotional well-being and may be a valuable addition to weight loss interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Mindfulness-Based Weight Loss Intervention on Long-Term Psychological Well-Being Among Adults with Obesity: Secondary Analyses from the Supporting Health by Integrating Nutrition and Exercise (SHINE) Trial. Hooker, AR., Sagui-Henson, SJ., Daubenmier, J., et al.[2023]

A 6-week mindfulness intervention for emotional eating showed significant improvements in key psychological factors like food-cue reactivity, intuitive eating, and emotional impulse regulation among 14 participants, mostly women, indicating its potential effectiveness in addressing emotional eating.

The study suggests that mindfulness training could be beneficial before starting weight loss efforts, as it targets the emotional and psychological aspects of overeating, although the intervention did not focus on weight loss itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based emotional eating awareness training: taking the emotional out of eating. Lattimore, P.[2021]

A low dose Mindfulness-Based Intervention (MBI-ld) was tested on 186 university faculty and staff with elevated CRP levels, showing significant improvements in mindfulness over 2 months, which were maintained for up to a year.

While MBI-ld did not lead to significant changes in cortisol or IL-6 levels, it showed a clinically relevant reduction in CRP levels, particularly in participants with a BMI under 30, suggesting potential benefits for inflammation management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Workplace based mindfulness practice and inflammation: a randomized trial. Malarkey, WB., Jarjoura, D., Klatt, M.[2021]

A 1-week savoring intervention for 111 older adults (ages 60 and over) showed significant improvements in psychological resilience, depressive symptoms, and happiness, indicating its effectiveness for this age group.

Participants who engaged in the savoring intervention with high fidelity experienced lasting benefits, suggesting that this technique can enhance well-being in older adults over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Savoring Intervention on Resilience and Well-Being of Older Adults. Smith, JL., Hanni, AA.[2020]

A self-help e-savoring intervention significantly increased savoring beliefs and positive emotions in 23 emerging adults compared to a control group of 26 participants during the COVID-19 pandemic.

Participants found the online platform for the intervention to be user-friendly and effective, suggesting that such digital approaches could be beneficial for enhancing subjective well-being in young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Savoring life during pandemic: an online intervention to promote well-being in emerging adults. Villani, D., Pancini, E., Pesce, F., et al.[2023]

Two randomized controlled trials involving stressed community adults investigated the impact of mindfulness training on inflammation, specifically the inflammatory biomarker C-Reactive Protein (CRP).

While the mindfulness training that included acceptance skills did not significantly reduce CRP levels, both mindfulness interventions showed potential in lowering inflammation in specific populations, such as midlife-to-older adults and those with high BMI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness training and systemic low-grade inflammation in stressed community adults: Evidence from two randomized controlled trials. Villalba, DK., Lindsay, EK., Marsland, AL., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Mindfulness and Savoring: A Commentary on Savoring Strategies and Their Implications for Addiction Treatment. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Mindfulness facets differentially relate to self-reported negative and positive emotional eating types in treatment-seeking adults with overweight/obesity. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Taking a closer look at mindful eating: incremental validity and importance of subfacets. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Mindful Eating: Connecting With the Wise Self, the Spiritual Self. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based group intervention in adolescents at-risk for excess weight gain: A randomized controlled pilot study. [2023]

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

Mindfulness-based intervention in adolescents at risk for excess weight gain: 1.5-year follow-up of pilot randomized controlled trial. [2022]

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

Effects of a Mindfulness-Based Weight Loss Intervention on Long-Term Psychological Well-Being Among Adults with Obesity: Secondary Analyses from the Supporting Health by Integrating Nutrition and Exercise (SHINE) Trial. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Mindfulness-based emotional eating awareness training: taking the emotional out of eating. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Workplace based mindfulness practice and inflammation: a randomized trial. [2021]

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

Effects of a Savoring Intervention on Resilience and Well-Being of Older Adults. [2020]

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

Savoring life during pandemic: an online intervention to promote well-being in emerging adults. [2023]

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

Mindfulness training and systemic low-grade inflammation in stressed community adults: Evidence from two randomized controlled trials. [2020]