Stress Sensitivity and Reward Responsivity in Depression (CAN-BIND-04)

August 26, 2019 updated by: Dr. Kate Harkness

Stress Sensitivity and Reward Responsivity: An Integration of Two Endophenotypes in Major Depression

The goal of this project is to learn more about the different ways in which people process information that is stressful and rewarding, and how abnormalities in these two processes are related to depression.

Study Overview

Status

Completed

Conditions

Detailed Description

Participants will participate in two 3-hour sessions separated by a week at Providence Care, Mental Health Services, and a third, 1.5-hour session at the Queen's MRI Facility. At the first session participants will complete a packet of questionnaires about their mood and take part in an interview about their mood, medications, drug use, and any other symptoms, as well as an interview about their relationships with their parents and any experiences of abuse. At the second session participants will participate in a stress test, which involves giving a speech to a panel. The investigators will also collect saliva samples to look at stress hormones. Participants will also complete a task on the computer that involves looking at cartoon faces and making decisions about them. At the third session, the investigators take images of of participant's brain using a magnetic resonance scanner.

Participants are invited to participate in a 6-month follow-up for this study, which would involve the same procedure as outline above.

Study Type

Observational

Enrollment (Actual)

219

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
        • Queen's University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

For Depressed Participants:

Inclusion Criteria:

  • Outpatients aged 18-65
  • Currently suffering from unipolar depression
  • Fluency in English, sufficient to complete the interviews and self-report questionnaires

Exclusion Criteria:

  • Clinical diagnosis of bipolar disorder, psychotic disorders, current alcohol/substance dependence, or significant medical comorbidity
  • Treatment-resistant (defined as failing more than 3 trials of anti-depressant medication)
  • History of neurological insult (e.g., concussion), neurological disease, seizure disorder
  • Smokers
  • Pregnant women
  • Endocrine disorders
  • High suicidal risk, defined by clinician judgement

For Healthy Control Participants:

Inclusion Criteria:

  • Adults aged 18-65
  • No history of Axis I disorders according to DSM-IV-TR criteria, as determined by the SCID
  • No first-degree relatives diagnosed with bipolar disorder
  • Fluency in English, sufficient to complete the interviews and self-report questionnaires

Exclusion Criteria:

  • History of neurological insult (e.g., concussion), neurological disease, seizure disorder
  • Smokers
  • Pregnant women
  • Endocrine disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Depressed Participants
No intervention
Healthy Control Participants
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress Sensitivity: Salivary Hormone and Stress Challenge Test (TSST)
Time Frame: 2 hours after beginning of Time B Appointment
Participants are required to give a speech and an arithmetic test in front of a panel. Saliva samples are collected at 8 points throughout the test.
2 hours after beginning of Time B Appointment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood and Anxiety Symptom Questionnaire (MASQ)
Time Frame: Administered at first baseline appointment and covers past 2 weeks
Self-report scale of general distress (GD), anhedonic depression (AD), and anxious arousal (AA) symptoms
Administered at first baseline appointment and covers past 2 weeks
Reward Responsivity: Probabilistic Reward Task
Time Frame: Administered at second baseline appointment
Computerized task that requires participants to choose between two stimuli and develop a response bias to the more frequently rewarded stimulus.
Administered at second baseline appointment
Snaith Hamilton Pleasure Scale (SHAPS and SHAPS-C)
Time Frame: Administered at first baseline appointment and covers past 2 weeks prior to interview
Self-report of anhedonia symptoms
Administered at first baseline appointment and covers past 2 weeks prior to interview

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kate Harkness, PhD, Queens University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

May 13, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSYC-154-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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