Brief Mood Enhancement Intervention

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT02954965
Collaborator
(none)
66
1
3
13
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Study Details

Study Description

Brief Summary

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.
Condition or Disease Intervention/Treatment Phase
  • Behavioral: Reward
  • Behavioral: Approach
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Enhancing Mood Among Graduate Students: Evaluation of a Brief, Phone-Administered Behavioral Intervention
Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

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.

Behavioral: Reward
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.

Behavioral: Approach
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

Outcome Measures

Primary Outcome Measures

  1. Change in burnout, as measured by the School Burnout Inventory total score [baseline (day 0) and post-intervention (day 10)]

    Self-report questionnaire assessing burnout

  2. Change in stress, as measured by the Perceived Stress Scale total score [baseline (day 0) and post-intervention (day 10)]

    Self-report questionnaire assessing stress

Secondary Outcome Measures

  1. Change in mastery, as measured by the Pearlin Personal Mastery Scale total score [baseline (day 0) and post-intervention (day 10)]

    Self-report questionnaires assessing mastery

  2. Change in avoidance, as measured by the Brief Experiential Avoidance Questionnaire total score [baseline (day 0) and post-intervention (day 10)]

    Self-report questionnaires assessing avoidance

  3. Change in mood, as measured by the Positive and Negative Affect Schedule total scores for Positive and Negative Affect [baseline (day 0) and post-intervention (day 10)]

    Self-report questionnaire assessing mood

  4. Change in reward, as measured by the Environmental Reward Observation Scale total score [baseline (day 0) and post-intervention (day 10)]

    Self-report questionnaires assessing environmental reward

  5. Change in behavioral activation, as measured by the Activation sub-scale of the Behavioral Activation for Depression Scale [baseline (day 0) and post-intervention (day 10)]

    Self-report questionnaires assessing behavioral activation

  6. Change in functional impairment, as measured by the Modified Work and Social Adjustment Scale total score [baseline (day 0) and post-intervention (day 10)]

    Self-report questionnaire assessing functional impairment

  7. Change in quality of life, as measured by the WHOQOL-BREF total score [baseline (day 0) and post-intervention (day 10)]

    Self-report questionnaire assessing quality of life

  8. Change in depression symptoms, as measured by the General Depression scale of the Inventory of Depression and Anxiety Symptoms [baseline (day 0) and post-intervention (day 10)]

    Self-report questionnaire assessing depression symptoms

  9. Change in mastery, as measured by the average of the daily Importance ratings of activities (0-10) on the Daily Activities Monitoring Form [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

  10. Change in avoidance, as measured by the total score of the Avoidance/Rumination sub-scale of the Behavioral Activation for Depression Scale [baseline (day 0) and post-intervention (day 10)]

    Self-report questionnaire assessing avoidance and rumination

  11. Change in environmental reward, as measured by the average of the daily Pleasure ratings of activities (0-10) on the Daily Activities Monitoring Form [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27705

Sponsors and Collaborators

  • Duke University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT02954965
Other Study ID Numbers:
  • PRO00074337
First Posted:
Nov 4, 2016
Last Update Posted:
Feb 23, 2018
Last Verified:
Feb 1, 2018
Keywords provided by Duke University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2018