Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03828604
Other study ID # SIWB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 12, 2017
Est. completion date May 9, 2018

Study information

Verified date February 2019
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date May 9, 2018
Est. primary completion date December 8, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 28 Years
Eligibility Inclusion Criteria:

- English fluency

- Age 18-28

- Biologically female

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Stress; Trier Social Stress Task
Standardized acute psychosocial stressor
Placebo Trier Social Stress Task
Active control version of the TSST

Locations

Country Name City State
United States Clinical and Translational Research Center, University of California, Los Angeles Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles UCLA Norman Cousins Center for Psychoneuroimmunology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Depressive symptoms The 20-item Center for Epidemiological Studies Depression Scale (CESD) is a self-report measure; participants are asked to rate how often they have experienced depressed feelings, attitudes, and behavioral symptoms during the past week (0 = rarely; 3 = most of the time). The total score range is 0 to 60, with higher scores indicating higher depressive symptoms. Change in depressive symptoms from study entry to 4-month follow-up
Other Affective experience during the experimental session Emotional reactivity and recovery from the TSST/P-TSST will be assessed using items from the Positive and Negative Affect Schedule and the Profile of Mood States. Participants rate how they feel "right now (that is, at the present moment) on a 1 (very slightly or not at all) to 5 (extremely) Likert scale. Average scores for subscales are reported, including positive and negative affect (7 items each), fatigue (8 items) vigor (5 items) and confusion (7 items). Participants also use visual analogue scales (VAS) to indicate how stressed, anxious, angry, confident, calm, socially connected and happy they are currently feeling on a 0 (not at all) to 100 (extremely) scale. The VAS are completed alongside the PANAS and three additional times during the TSST/P-TSST. Entry, pre-TSST/P-TSST; during TSST/P-TSST; 60, 90, 120, 150 min post TSST/P-TSST
Primary 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). Pre-TSST/P-TSST and 90 min post-TSST/P-TSST
Primary 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) Pre-TSST/P-TSST and 120 min post-TSST/P-TSST
Primary Attentional Bias Task Change in attentional bias from pre to post-TSST/P-TSST Pre-TSST/P-TSST and 110 min post-TSST/P-TSST
Secondary 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 120 min post-TSST
Secondary Face Morphing Task Change in latency to detect emotional expressions Pre-TSST/P-TSST and 115 min post-TSST/P-TSST
See also
  Status Clinical Trial Phase
Completed NCT04549194 - Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Recruiting NCT05419934 - EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial N/A
Completed NCT03689348 - Acute and Chronic Effects of Avena Sativa on Cognition and Stress N/A
Active, not recruiting NCT05114824 - Acceptability and Feasibility of an 8-week Online Mindfulness-Based Cognitive Therapy Program Among Undergraduate Students N/A
Recruiting NCT05991739 - Pilot Testing of a Structural Racism Intervention for Immigrant Latinx Families N/A
Not yet recruiting NCT05491122 - The Influence of Fluid Intake on Daily Biological Rhythm and Mental Performance in Healthy Young Adults N/A
Completed NCT02982070 - TU Tough: Mental Toughness Training for College Success N/A
Completed NCT02844478 - Stress-Busting Program and QoL, Bio-markers of Immunity/Stress and Cellular Aging N/A
Completed NCT02417454 - Study on the Effects of a Probiotic on Autonomic and Psychological Stress Phase 3
Completed NCT06014970 - The Health and Wellness Curriculum Assessment N/A
Completed NCT01946893 - Mindfulness Meditation for Cognition and Mood N/A
Completed NCT01637363 - Psychoeducation to Sick-listed Individuals With Mental Health Problems N/A
Completed NCT01343810 - Stress Reduction Training to Improve Sleep Quality, Stress Physiology & Cardiovascular Disease (CVD) Risk Markers N/A
Completed NCT00661271 - Mindfulness-based Stress Reduction for Urban Youth N/A
Recruiting NCT04417153 - Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes
Completed NCT04125810 - A Study to Assess the Safety and Efficacy of Probiotic to Modulate Psychological Stress Phase 2
Completed NCT04023968 - Student Wellness Workshop Study N/A
Completed NCT03233750 - Simulation-Based Stress Inoculation Training N/A