Brief Mood Enhancement Intervention

February 21, 2018 updated by: Duke University

Enhancing Mood Among Graduate Students: Evaluation of a Brief, Phone-Administered Behavioral Intervention

The purpose of the current study is to test the efficacy of two brief, behavioral interventions intended to improve burnout among doctoral-level graduate students (n = 102). Specifically, individuals will be randomly assigned to one of three intervention conditions: 1) Reward: a brief intervention to help participants increase engagement in healthy and rewarding values-driven behaviors, 2) Approach: a brief intervention to help participants identify and decrease emotion-driven avoidance of important goals, or 3) Control: a control condition that involves monitoring only. Multilevel modeling will be used to assess changes in burnout, mood, and stress, following the interventions, controlling for participants' individual baseline levels of these variables.

Study Overview

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

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

    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

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 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Currently enrolled in any in-person (not online) Ph.D. program in the state of North Carolina
  • Demonstrating above average levels of burnout
  • Has regular access to the Internet
  • Has a Social Security Number
  • Is able to read and understand English

Exclusion Criteria:

  • Current mania or psychosis
  • Current suicidal ideation
  • Are currently in psychotherapy, have been in psychotherapy in the past 8 weeks, or are planning to start psychotherapy during the course of the 10-day study
  • Have had any changes in psychiatric medications in the past 8 weeks, are not taking medications as prescribed or are planning to change medications during the course of the 10-day study
  • Are currently taking benzodiazepines Pro Re Nata (PRN)
  • Are under 18 years old

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reward
A brief, phone-administered intervention designed to help graduate students increase the number of pleasant and rewarding activities in their daily lives.
Brief behavioral intervention (administered during a 45-minute phone call) that is designed to improve graduate student burnout by helping participants to identify activities that are rewarding and pleasurable and to integrate these activities into their schedule.
Experimental: Approach
A brief, phone-administered intervention designed to help graduate students block procrastination and avoidance and to approach important activities they are currently avoiding.
Brief behavioral intervention (administered during a 45-minute phone call) that is designed to improve graduate student burnout by helping participants to identify activities that are challenging, but important to their long-term goals and values, and to integrate these activities into their schedule.
No Intervention: Monitoring
Participants will monitor their current behaviors, mood, and burnout with no directed intervention to change behavior

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in burnout, as measured by the School Burnout Inventory total score
Time Frame: baseline (day 0) and post-intervention (day 10)
Self-report questionnaire assessing burnout
baseline (day 0) and post-intervention (day 10)
Change in stress, as measured by the Perceived Stress Scale total score
Time Frame: baseline (day 0) and post-intervention (day 10)
Self-report questionnaire assessing stress
baseline (day 0) and post-intervention (day 10)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mastery, as measured by the Pearlin Personal Mastery Scale total score
Time Frame: baseline (day 0) and post-intervention (day 10)
Self-report questionnaires assessing mastery
baseline (day 0) and post-intervention (day 10)
Change in avoidance, as measured by the Brief Experiential Avoidance Questionnaire total score
Time Frame: baseline (day 0) and post-intervention (day 10)
Self-report questionnaires assessing avoidance
baseline (day 0) and post-intervention (day 10)
Change in mood, as measured by the Positive and Negative Affect Schedule total scores for Positive and Negative Affect
Time Frame: baseline (day 0) and post-intervention (day 10)
Self-report questionnaire assessing mood
baseline (day 0) and post-intervention (day 10)
Change in reward, as measured by the Environmental Reward Observation Scale total score
Time Frame: baseline (day 0) and post-intervention (day 10)
Self-report questionnaires assessing environmental reward
baseline (day 0) and post-intervention (day 10)
Change in behavioral activation, as measured by the Activation sub-scale of the Behavioral Activation for Depression Scale
Time Frame: baseline (day 0) and post-intervention (day 10)
Self-report questionnaires assessing behavioral activation
baseline (day 0) and post-intervention (day 10)
Change in functional impairment, as measured by the Modified Work and Social Adjustment Scale total score
Time Frame: baseline (day 0) and post-intervention (day 10)
Self-report questionnaire assessing functional impairment
baseline (day 0) and post-intervention (day 10)
Change in quality of life, as measured by the WHOQOL-BREF total score
Time Frame: baseline (day 0) and post-intervention (day 10)
Self-report questionnaire assessing quality of life
baseline (day 0) and post-intervention (day 10)
Change in depression symptoms, as measured by the General Depression scale of the Inventory of Depression and Anxiety Symptoms
Time Frame: baseline (day 0) and post-intervention (day 10)
Self-report questionnaire assessing depression symptoms
baseline (day 0) and post-intervention (day 10)
Change in mastery, as measured by the average of the daily Importance ratings of activities (0-10) on the Daily Activities Monitoring Form
Time Frame: baseline (days 0-3) and intervention (days 3-10)
Self-report monitoring form describing activities during the day, how enjoyable they were, and how important they were
baseline (days 0-3) and intervention (days 3-10)
Change in avoidance, as measured by the total score of the Avoidance/Rumination sub-scale of the Behavioral Activation for Depression Scale
Time Frame: baseline (day 0) and post-intervention (day 10)
Self-report questionnaire assessing avoidance and rumination
baseline (day 0) and post-intervention (day 10)
Change in environmental reward, as measured by the average of the daily Pleasure ratings of activities (0-10) on the Daily Activities Monitoring Form
Time Frame: baseline (days 0-3) and intervention (days 3-10)
Self-report monitoring form describing activities during the day, how enjoyable they were, and how important they were
baseline (days 0-3) and intervention (days 3-10)

Collaborators and Investigators

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

Sponsor

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

November 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 30, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 4, 2016

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

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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