NCT03828604

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

January 31, 2019

Last Update Submit

February 1, 2019

Conditions

Keywords

reward processing

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Effort Expenditure for Rewards Task - Reward Sensitivity

    120 min post-TSST

  • Face Morphing Task

    Pre-TSST/P-TSST and 115 min post-TSST/P-TSST

Other Outcomes (2)

  • Depressive symptoms

    Change in depressive symptoms from study entry to 4-month follow-up

  • Affective experience during the experimental session

    Entry, pre-TSST/P-TSST; during TSST/P-TSST; 60, 90, 120, 150 min post TSST/P-TSST

Study Arms (2)

Stress; Trier Social Stress Task

EXPERIMENTAL

5 min challenging speech task, 5 min challenging math task; performed in front of evaluators

Behavioral: Stress; Trier Social Stress Task

Placebo Trier Social Stress Task

ACTIVE COMPARATOR

5 min speech task, 5 min math task; performed alone

Behavioral: Placebo Trier Social Stress Task

Interventions

Standardized acute psychosocial stressor

Stress; Trier Social Stress Task

Active control version of the TSST

Placebo Trier Social Stress Task

Eligibility Criteria

Age18 Years - 28 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • English fluency
  • Age 18-28
  • Biologically female

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical and Translational Research Center, University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Chloe C Boyle, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
  • Julienne E Bower, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Acute Psychosocial stress vs. Non-stress active control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 4, 2019

Study Start

May 12, 2017

Primary Completion

December 8, 2017

Study Completion

May 9, 2018

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations