Skip to content

Effects of a Wellbeing Intervention on Inflammation Through Reward and Threat Processes

Effects of a Wellbeing Intervention on Inflammation Through Reward and Threat Processes

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06294145
Acronym
SAVOR
Enrollment
30
Registered
2024-03-05
Start date
2024-02-07
Completion date
2025-05-01
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Positive Affect

Brief summary

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.

Detailed description

Interventions that enhance wellbeing have the power to improve both mental and physical health, but the exact mechanisms through which they confer these benefits remain unclear. Inflammation may be a key pathway; there is substantial evidence that both eudaimonic and hedonic wellbeing are associated with lower levels of inflammatory activity (Cole et al., 2015; Brouwers et al., 2013; Ironson et al., 2018), which may in turn have beneficial effects on health (Furman et al., 2019). However, wellbeing may influence inflammation through multiple mechanisms, including reward and threat processes (Dutcher et al., 2021; Eisenberger & Cole, 2012). Identifying the mediating circuitry will help guide the development of targeted interventions able to protect against inflammation-related diseases, like depression. However, reward and threat processes have yet to be examined as potential mediators of wellbeing's effects on inflammation and health. This study aims to evaluate how wellbeing may influence reward and threat processing and downstream inflammation using a novel savoring intervention (Positive Affect Treatment; PAT)(Craske et al., 2016; Craske et al., 2019). Savoring is a common component of many positive psychology and mindfulness interventions that involves cultivating sustained enjoyment of positive experiences. It is designed to enhance reward processing, which should in turn decrease threat processing and lead to blunted stress responses and reduced downstream inflammation (Eisenberger & Cole, 2012). The investigators will collect daily diaries, neuroimaging, and questionnaires pre- and post-intervention to assess wellbeing, reactivity to social and nonsocial rewarding experiences, and buffering of stressful experiences in a single-armed pilot trial of 20 participants from the diverse undergraduate population at UCLA. The investigators will also collect blood samples to facilitate examination of immunological biomarkers. By examining reward and threat processing at multiple levels inside and outside of the laboratory, the investigators aim to strengthen the understanding of how wellbeing alters the way humans perceive and interact with the world. Increased reward reactivity and decreased threat reactivity may be two key mechanisms through which wellbeing impacts stress physiology and downstream inflammation. The investigators will examine if the savoring intervention is associated with decreases in circulating inflammatory biomarkers, such as interleukin-6 (IL-6) and C-Reactive Protein (CRP), as well as reductions in pro-inflammatory gene expression. This study will also clarify whether savoring is an "active ingredient" driving the mental and physical benefits of many positive psychology and mindfulness interventions.

Interventions

BEHAVIORALSavoring Intervention

The savoring intervention is the first module of the Positive Affect Treatment (PAT) developed by Michelle Craske and colleagues to treat anhedonia, or loss of interest or pleasure in usual activities. The investigators focus here on the behavioral activation and savoring components of the intervention, which are administered first and are considered the basis for other components. Of note, a variety of other positive psychology interventions include a savoring component, but PAT is unique in its inclusion of six sessions devoted to savoring. These sessions involve pleasant events scheduling in which participants: 1) plan activities that generate anticipation of reward, 2) engage in activities that generate reward and 3) practice therapist-guided-in-the-moment recounting of positive emotions, sensations, and thoughts generated by these activities. The investigators will additionally include an introductory psychoeducation session before the savoring module, as PAT does.

Sponsors

University of California, Los Angeles
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

All 20 participants will be assigned to the same 7-week savoring intervention.

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

* Moderate to moderately severe depression indicated by a PHQ-8 score between 9 and 20 * Low positive affect indicated by a PANAS score of less than 24 * No anxiety to moderate anxiety indicated by a GAD-7 score of less than 15 * 18 to 25 years old * English speaking * Willing 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) * Presence of disease that may influence inflammation (e.g. asthma requiring inhaler, autoimmune or inflammatory diseases, gum disease, sleep disorder, eating disorder) * Presence of serious medical conditions (e.g. anemia, cancer (current or history), diabetes, endocrine disorder, fibromyalgia, heart problems) * Presence of disease that may impact patterns of neural activity (e.g. Attention Deficit/Hyperactivity Disorder, bipolar disorder, schizophrenia, head trauma, epilepsy, problems with drugs or alcohol) * Use of medications that may influence inflammation in last 6 months * Bupropion, dopaminergic or neuroleptic medications in last 6 months, consistent with other studies that investigate anhedonia, given their potential influence upon reward processing * Current use of heterocyclics and SSRIs if not stabilized for at least 3 months * History of regular (5-7 times per week) drug use (marijuana, cocaine, stimulant use before age of 15) * Current nicotine use (more than 11 cigarettes a week or nicotine equivalent) * Prior or current behavioral activation psychotherapy * Concurrent psychotherapy

Design outcomes

Primary

MeasureTime frameDescription
Positive Affect9 weeks post start of interventionPost-intervention positive affect. Positive affect was assessed via the 10-item positive affect subscale of the Positive and Negative Affect Schedule (PANAS-X). Greater scores indicate higher positive affect (range: 10-50).

Secondary

MeasureTime frameDescription
Negative Affect9 weeks post start of interventionPost-intervention negative affect. Negative affect was assessed via the 10-item negative affect subscale of the Positive and Negative Affect Schedule (PANAS-X). Greater scores indicate more negative affect (range: 10-50).
Depression9 weeks post start of interventionPost-intervention depressive symptoms. Depressive symptoms were measured via the 8-item Patient Health Questionnaire (PHQ-8). The PHQ-8 is a measure of symptom severity, with higher scores indicating greater depressive symptoms (range: 0-24).
Anxiety9 weeks post start of interventionPost-intervention anxiety symptoms. Symptoms of anxiety were measured via the 7-item Generalized Anxiety Disorder- 7 (GAD-7). Higher scores on the GAD-7 (range: 0-21) indicate greater severity of symptoms.
Perceived Stress9 weeks post start of interventionPost-intervention perceived stress. Perceived stress was measured via the 4-item Perceived Stress Scale (range: 0-16). Higher scores indicate greater perceived stress levels.
Psychological Wellbeing9 weeks post start of interventionPost-intervention psychological wellbeing. Wellbeing measured via the 14-item Mental Health Continuum - Short Form (MHC-SF) (range: 0-70). Higher scores indicate greater wellbeing.
Positive Emotions9 weeks post start of interventionPost-intervention positive emotions. Positive emotions were measured via the 20-item Modified Differential Emotions Scale (mDES) using the 10 items that ask about positive emotions (range: 0-20). Higher scores indicate greater positive emotions.
Reward9 weeks post start of interventionPost-intervention reward. Reward was be measured via the 21-item Positive Valence Systems Scale (range: 21-189). Higher scores indicate greater reward activity.
Savoring Strategies9 weeks post start of interventionPost-intervention savoring. Measured via 27 questions from the Ways of Savoring Checklist (WOSC) scale. This measure contains five subscales of interest: memory building, sensory-perceptual sharpening, absorption, temporal awareness, and kill-joy thinking items. Each scale was scored by taking the mean. Higher total savoring scores indicate more use of memory building, sensory-perceptual sharpening, absorption, and temporal awareness, as well as less kill-joy thinking. The range is 5 to 35.
Interoception9 weeks post start of interventionPost-intervention interoception. Interoception was measured via the 37-item Multidimensional Assessment of Interoceptive Awareness (MAIA-2) scale. This measure contains eight subscales: Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting. Each scale was scored by taking the mean (between 0 and 5). The total has a range from 0 to 40.
InflammationBaseline and at 9 weeksThe primary immune outcome of interest is inflammation assessed through gene expression. Inflammatory gene expression will be measured through a pre-specified set of pro-inflammatory gene transcripts that have previously been shown to be upregulated in the context of chronic stress.
Sustained AttentionBaseline and at 9 weeksChange in sustained attention to positive and negative stimuli. Sustained attention to stimuli will be measured with a modified Attentional Dot Probe Task. Higher scores indicate greater sustained attention to stimuli.
Neural Reward ActivityBaseline and at 9 weeksChange in neural reward reactivity. Reward activity will be assessed via three tasks: viewing positive pictures with the International Affective Picture System Task, responding to monetary rewards with the Monetary Incentive Delay Task, and a novel savoring task in the scanner. More activation in reward-related regions during parts of these tasks indicates greater neural reward activity. The impact of social vs. non-social stimuli will be examined as well.
Neural Threat ActivityBaseline and at 9 weeksChange in neural threat activity. Neural threat activity will be measured with the Montreal Imaging Stress Task in the scanner. More activation in threat-related regions during parts of this task indicates greater neural threat activity.
Daily DiaryBaseline and at 9 weeksChange in daily experiences of reward and threat. On a daily basis, participants will report on the occurrence of positive and negative events throughout the day, and then report on their positive and negative emotions. The impact of positive and negative events on mood will be examined; the impact of social vs. non-social events will be examined as well.

Countries

United States

Participant flow

Recruitment details

Recruitment was conducted on a rolling basis from February 2024 through March 2025. Participants were recruited via advertisements on the UCLA campus. Thirty undergraduate students meeting eligibility criteria were enrolled into the single-arm intervention study.

Baseline characteristics

Characteristic
Age, Continuous19 Years
STANDARD_DEVIATION 1.24
Anxiety8.53 Points
STANDARD_DEVIATION 4.08
Depression10.73 Points
STANDARD_DEVIATION 3.48
Interoception15.46 Points
STANDARD_DEVIATION 4.54
Negative Affect25.7 Points
STANDARD_DEVIATION 6.44
Perceived Stress8.83 Points
STANDARD_DEVIATION 2
Positive Affect22.67 Points
STANDARD_DEVIATION 4.38
Positive Emotions13.23 Points
STANDARD_DEVIATION 5.64
Psychological wellbeing29.43 Points
STANDARD_DEVIATION 8.94
Race/Ethnicity, Customized
Asian
10 Participants
Race/Ethnicity, Customized
Hispanic
6 Participants
Race/Ethnicity, Customized
Indian Subcontinent
4 Participants
Race/Ethnicity, Customized
Middle Eastern
1 Participants
Race/Ethnicity, Customized
Mixed
4 Participants
Race/Ethnicity, Customized
White
5 Participants
Reward124.17 Points
STANDARD_DEVIATION 21.84
Savoring Strategies18.50 Points
STANDARD_DEVIATION 2.55
Sex/Gender, Customized
Man (including transgender men)
3 Participants
Sex/Gender, Customized
Non-binary, gender fluid
1 Participants
Sex/Gender, Customized
Woman (including transgender women)
26 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 30
other
Total, other adverse events
1 / 30
serious
Total, serious adverse events
0 / 30

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026