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Low Positive AffectSAVORNCT06294145

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

A study testing Savoring Intervention in people with Low Positive Affect, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 25 years
Conditions the study is for
Low Positive Affect
What is being tested?
Savoring Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
7 Feb 2024to 1 May 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, Los Angeles

    Los Angeles, California, 90095

Other trials in United States

About this study

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.

Read the 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.

Being tested
Savoring Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Savoring InterventionBehavioural

    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.

Study groups in NCT06294145
Study groupRoleWhat they receive
Savoring interventionExperimental7 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning.
Receives: Behavioral: Savoring Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive Affect

    Post-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).

    Measured: 9 weeks post start of intervention

Secondary outcomes (14)
  1. Negative Affect

    Post-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).

    Measured: 9 weeks post start of intervention

  2. Depression

    Post-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).

    Measured: 9 weeks post start of intervention

  3. Anxiety

    Post-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.

    Measured: 9 weeks post start of intervention

  4. Perceived Stress

    Post-intervention perceived stress. Perceived stress was measured via the 4-item Perceived Stress Scale (range: 0-16). Higher scores indicate greater perceived stress levels.

    Measured: 9 weeks post start of intervention

  5. Psychological Wellbeing

    Post-intervention psychological wellbeing. Wellbeing measured via the 14-item Mental Health Continuum - Short Form (MHC-SF) (range: 0-70). Higher scores indicate greater wellbeing.

    Measured: 9 weeks post start of intervention

  6. Positive Emotions

    Post-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.

    Measured: 9 weeks post start of intervention

  7. Reward

    Post-intervention reward. Reward was be measured via the 21-item Positive Valence Systems Scale (range: 21-189). Higher scores indicate greater reward activity.

    Measured: 9 weeks post start of intervention

  8. Savoring Strategies

    Post-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.

    Measured: 9 weeks post start of intervention

  9. Interoception

    Post-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.

    Measured: 9 weeks post start of intervention

  10. Inflammation

    The 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.

    Measured: Baseline and at 9 weeks

  11. Sustained Attention

    Change 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.

    Measured: Baseline and at 9 weeks

  12. Neural Reward Activity

    Change 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.

    Measured: Baseline and at 9 weeks

  13. Neural Threat Activity

    Change 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.

    Measured: Baseline and at 9 weeks

  14. Daily Diary

    Change 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.

    Measured: Baseline and at 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2024
  2. Study start7 Feb 2024
  3. Primary completion1 May 2025
  4. Study completion1 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
All 20 participants will be assigned to the same 7-week savoring intervention.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06294145
Sponsor's protocol ID
23-001666
Other IDs
U24AG072699
Acronym
SAVOR
Status last verified
Jul 2026
First submitted
27 Feb 2024
Last updated
1 Sep 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data will be housed on UCLA servers and kept there throughout the grant and afterwards. To request access of the data, researchers will use the standard processes at UCLA. No personally identifiable information will be shared. Access to data will be granted to researchers who can demonstrate a clear scientific purpose that aligns with the goals of the original study. Requests must come from accredited institutions or organizations that uphold ethical research standards. Each request will be reviewed on a case-by-case basis to ensure it meets the necessary criteria. Approval will be subject to the data sharing policies of UCLA and the ethical guidelines governing the research. All co-investigators will be consulted to determine the appropriateness of data sharing.

Publications

  • Cole SW, Levine ME, Arevalo JM, Ma J, Weir DR, Crimmins EM. Loneliness, eudaimonia, and the human conserved transcriptional response to adversity. Psychoneuroendocrinology. 2015 Dec;62:11-7. doi: 10.1016/j.psyneuen.2015.07.001. Epub 2015 Jul 8.

    PubMed 26246388
  • Brouwers C, Mommersteeg PM, Nyklicek I, Pelle AJ, Westerhuis BL, Szabo BM, Denollet J. Positive affect dimensions and their association with inflammatory biomarkers in patients with chronic heart failure. Biol Psychol. 2013 Feb;92(2):220-6. doi: 10.1016/j.biopsycho.2012.10.002. Epub 2012 Oct 23.

    PubMed 23085133
  • Ironson G, Banerjee N, Fitch C, Krause N. Positive emotional well-being, health Behaviors, and inflammation measured by C-Reactive protein. Soc Sci Med. 2018 Jan;197:235-243. doi: 10.1016/j.socscimed.2017.06.020. Epub 2017 Jul 10.

    PubMed 28701268
  • Furman D, Campisi J, Verdin E, Carrera-Bastos P, Targ S, Franceschi C, Ferrucci L, Gilroy DW, Fasano A, Miller GW, Miller AH, Mantovani A, Weyand CM, Barzilai N, Goronzy JJ, Rando TA, Effros RB, Lucia A, Kleinstreuer N, Slavich GM. Chronic inflammation in the etiology of disease across the life span. Nat Med. 2019 Dec;25(12):1822-1832. doi: 10.1038/s41591-019-0675-0. Epub 2019 Dec 5.

    PubMed 31806905
  • Dutcher JM, Boyle CC, Eisenberger NI, Cole SW, Bower JE. Neural responses to threat and reward and changes in inflammation following a mindfulness intervention. Psychoneuroendocrinology. 2021 Mar;125:105114. doi: 10.1016/j.psyneuen.2020.105114. Epub 2020 Dec 16.

    PubMed 33360032
  • Eisenberger NI, Cole SW. Social neuroscience and health: neurophysiological mechanisms linking social ties with physical health. Nat Neurosci. 2012 Apr 15;15(5):669-74. doi: 10.1038/nn.3086.

    PubMed 22504347
  • Craske MG, Meuret AE, Ritz T, Treanor M, Dour HJ. Treatment for Anhedonia: A Neuroscience Driven Approach. Depress Anxiety. 2016 Oct;33(10):927-938. doi: 10.1002/da.22490.

    PubMed 27699943
  • Craske MG, Meuret AE, Ritz T, Treanor M, Dour H, Rosenfield D. Positive affect treatment for depression and anxiety: A randomized clinical trial for a core feature of anhedonia. J Consult Clin Psychol. 2019 May;87(5):457-471. doi: 10.1037/ccp0000396.

    PubMed 30998048

Questions about this trial

What is this clinical trial studying?

A study testing Savoring Intervention in people with Low Positive Affect, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Affect (time frame: 9 weeks post start of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06294145, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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