Stress, PsychologicalNCT03828604
Stress-Induced Inflammation and Reward Processing
A study testing Stress; Trier Social Stress Task in people with Stress, Psychological, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Anhedonia, or loss of interest or pleasure, is a key feature of depression and transdiagnostic construct in psychopathology. Both theory and compelling evidence from preclinical models implicates stress-induced inflammation as a key psychobiological pathway to anhedonic behavior; however, this pathway has not been… Read more about this study
- Who is it for?
- Ages 18 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Stress; Trier Social Stress Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2017to 9 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 28 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- English fluency
- Age 18-28
- Biologically female
Who cannot join
- Current illness
- Presence or history of major medical conditions
- Current or past diagnosis of alcohol use disorder
- Use of tobacco
- Use of immune-altering medications
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Research Center, University of California, Los Angeles
Los Angeles, California, 90095
About this study
Anhedonia, or loss of interest or pleasure, is a key feature of depression and transdiagnostic construct in psychopathology. Both theory and compelling evidence from preclinical models implicates stress-induced inflammation as a key psychobiological pathway to anhedonic behavior; however, this pathway has not been demonstrated in human models. Further, although anhedonia may reflect dysregulation in multiple dimensions of reward, the extent to which stress-induced inflammation alters these dimensions is unclear. The current placebo controlled study used a standardized laboratory stressor task to elicit an inflammatory response in a sample of a healthy young women and evaluate effects of stress-induced inflammation on multiple behavioral indices of reward processing.
Read the detailed description
In this study we propose to examine the association between psychosocial stress, the stress-induced inflammatory response, and reward processing in a female undergraduate sample. Specifically, we will 1) examine effects of an acute psychosocial stressor on reward processing; 2) evaluate the association between stress-related changes in inflammation and reward processing; and 3) test key vulnerability factors that may moderate the association between stress and reward. To achieve these goals, this study will recruit 60 female undergraduate students to test effects of stress on reward processing in a 3.5 hour laboratory session. Participants will be randomly assigned to either experience a laboratory stressor or a placebo control, and will complete reward tasks 90 minutes post stress/placebo onset, at which point the peripheral inflammatory response to stress reaches its peak. The reward tasks are computerized behavioral tasks that assess three domains of reward processing: reward-learning, reward motivation, and reward sensitivity. Throughout the session, all participants will complete self-report measures of affect and provide blood and saliva samples for evaluation of the psychological and physiological stress response. Within one week prior to the session, participants will attend a 1 hour visit in which they complete baseline reward tasks and self-report questionnaires assessing mood, personality, early life stress, and health behaviors. In total, participants will complete two visits, with a duration of 4.5 hours. This study builds upon prior studies demonstrating immediate effects of acute stress on reward processing, and further tests for delayed effects of acute stress on reward processing. Furthermore, this will be the first study to examine inflammation as a mechanism linking stress to deficits in reward processing. Findings may inform theory of depression etiology and contribute to more specialized treatment that is targeted at specific symptoms of depression.
- Conditions
- Stress, Psychological
- Being tested
- Stress; Trier Social Stress Task, Placebo Trier Social Stress Task
- Keywords
- reward processing
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress; Trier Social Stress TaskBehavioural
Standardized acute psychosocial stressor
Placebo Trier Social Stress TaskBehavioural
Active control version of the TSST
| Study group | Role | What they receive |
|---|---|---|
| Stress; Trier Social Stress Task | Experimental | 5 min challenging speech task, 5 min challenging math task; performed in front of evaluators Receives: Behavioral: Stress; Trier Social Stress Task |
| Placebo Trier Social Stress Task | Active comparator | 5 min speech task, 5 min math task; performed alone Receives: Behavioral: Placebo Trier Social Stress Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probabilistic Reward Task - Reward Responsiveness
Change in the magnitude of response bias from pre to post Trier Social Stress Task (TSST) or Placebo-TSST (P-TSST).
Measured: Pre-TSST/P-TSST and 90 min post-TSST/P-TSST
Effort Expenditure for Rewards Task - Reward Motivation
Change in amount of hard trials chosen from pre to post-TSST/P-TSST (overall, and at 3 levels of probability of potential rewards; low, medium, and high)
Measured: Pre-TSST/P-TSST and 120 min post-TSST/P-TSST
Attentional Bias Task
Change in attentional bias from pre to post-TSST/P-TSST
Measured: Pre-TSST/P-TSST and 110 min post-TSST/P-TSST
Secondary outcomes (2)
Effort Expenditure for Rewards Task - Reward Sensitivity
Strength of the relationship between changes in reward magnitude and high effort trial choice as a function of degree of change in IL-6 following acute stress
Measured: 120 min post-TSST
Face Morphing Task
Change in latency to detect emotional expressions
Measured: Pre-TSST/P-TSST and 115 min post-TSST/P-TSST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start12 May 2017
- Primary completion8 Dec 2017
- Study completion9 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Acute Psychosocial stress vs. Non-stress active control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chloe Boyle, PhD, University of California, Los Angeles
- Investigators
- Chloe C Boyle, PhD, Principal investigator, University of California, Los AngelesJulienne E Bower, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828604
- Sponsor's protocol ID
- SIWB
- Status last verified
- Feb 2019
- First submitted
- 31 Jan 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boyle CC, Stanton AL, Eisenberger NI, Seeman TE, Bower JE. Effects of stress-induced inflammation on reward processing in healthy young women. Brain Behav Immun. 2020 Jan;83:126-134. doi: 10.1016/j.bbi.2019.09.023. Epub 2019 Sep 30.
PubMed 31580931
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress-Induced Inflammation and Reward Processing
- ClinicalTrials.gov ID
- NCT03828604
- Acronym / sponsor ID
- SIWB
- Conditions
- Stress, Psychological
- Keywords
- reward processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anhedonia, or loss of interest or pleasure, is a key feature of depression and transdiagnostic construct in psychopathology. Both theory and compelling evidence from preclinical models implicates stress-induced inflammation as a key psychobiological pathway to anhedonic behavior; however, this pathway has not been demonstrated in human models. Further, although anhedonia may reflect dysregulation in multiple dimensions of reward, the extent to which stress-induced inflammation alters these dimensions is unclear. The current placebo controlled study used a standardized laboratory stressor task to elicit an inflammatory response in a sample of a healthy young women and evaluate effects of stress-induced inflammation on multiple behavioral indices of reward processing.
Detailed description
In this study we propose to examine the association between psychosocial stress, the stress-induced inflammatory response, and reward processing in a female undergraduate sample. Specifically, we will 1) examine effects of an acute psychosocial stressor on reward processing; 2) evaluate the association between stress-related changes in inflammation and reward processing; and 3) test key vulnerability factors that may moderate the association between stress and reward. To achieve these goals, this study will recruit 60 female undergraduate students to test effects of stress on reward processing in a 3.5 hour laboratory session. Participants will be randomly assigned to either experience a laboratory stressor or a placebo control, and will complete reward tasks 90 minutes post stress/placebo onset, at which point the peripheral inflammatory response to stress reaches its peak. The reward tasks are computerized behavioral tasks that assess three domains of reward processing: reward-learning, reward motivation, and reward sensitivity. Throughout the session, all participants will complete self-report measures of affect and provide blood and saliva samples for evaluation of the psychological and physiological stress response. Within one week prior to the session, participants will attend a 1 hour visit in which they complete baseline reward tasks and self-report questionnaires assessing mood, personality, early life stress, and health behaviors. In total, participants will complete two visits, with a duration of 4.5 hours. This study builds upon prior studies demonstrating immediate effects of acute stress on reward processing, and further tests for delayed effects of acute stress on reward processing. Furthermore, this will be the first study to examine inflammation as a mechanism linking stress to deficits in reward processing. Findings may inform theory of depression etiology and contribute to more specialized treatment that is targeted at specific symptoms of depression.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Acute Psychosocial stress vs. Non-stress active control
| Arm | Type | Receives |
|---|---|---|
| Stress; Trier Social Stress Task | Experimental | Behavioral: Stress; Trier Social Stress Task5 min challenging speech task, 5 min challenging math task; performed in front of evaluators |
| Placebo Trier Social Stress Task | Active comparator | Behavioral: Placebo Trier Social Stress Task5 min speech task, 5 min math task; performed alone |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- English fluency
- Age 18-28
- Biologically female
Key exclusion criteria (6 listed)
- Current illness
- Presence or history of major medical conditions
- Current or past diagnosis of alcohol use disorder
- Use of tobacco
- Use of immune-altering medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress; Trier Social Stress TaskStandardized acute psychosocial stressor | Behavioural | Stress; Trier Social Stress Task |
| Placebo Trier Social Stress TaskActive control version of the TSST | Behavioural | Placebo Trier Social Stress Task |
Primary outcome
Probabilistic Reward Task - Reward Responsiveness
Time frame: Pre-TSST/P-TSST and 90 min post-TSST/P-TSST
Change in the magnitude of response bias from pre to post Trier Social Stress Task (TSST) or Placebo-TSST (P-TSST).
Effort Expenditure for Rewards Task - Reward Motivation
Time frame: Pre-TSST/P-TSST and 120 min post-TSST/P-TSST
Change in amount of hard trials chosen from pre to post-TSST/P-TSST (overall, and at 3 levels of probability of potential rewards; low, medium, and high)
Attentional Bias Task
Time frame: Pre-TSST/P-TSST and 110 min post-TSST/P-TSST
Change in attentional bias from pre to post-TSST/P-TSST
2 secondary outcomes
Effort Expenditure for Rewards Task - Reward Sensitivity
Time frame: 120 min post-TSST
Face Morphing Task
Time frame: Pre-TSST/P-TSST and 115 min post-TSST/P-TSST
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Derived from this study: PubMed 31580931Boyle CC, Stanton AL, Eisenberger NI, Seeman TE, Bower JE. Effects of stress-induced inflammation on reward processing in healthy young women. Brain Behav Immun. 2020 Jan;83:126-134. doi: 10.1016/j.bbi.2019.09.023. Epub 2019 Sep 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chloe C Boyle, PhD principal investigator
University of California, Los Angeles
Julienne E Bower, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress; Trier Social Stress Task in people with Stress, Psychological, 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 3 inclusion and 6 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 5 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Probabilistic Reward Task - Reward Responsiveness (time frame: Pre-TSST/P-TSST and 90 min post-TSST/P-TSST). The study lists 3 primary outcomes in all. 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 NCT03828604, which also lists 1 linked publication.
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 5 Feb 2019.