Brief Mood Enhancement Intervention

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02954965
• Other study ID #: PRO00074337
• Status: Completed
• Phase: N/A
• First received: September 30, 2016
• Last updated: February 21, 2018
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Professional
• Stress, Psychological

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in burnout, as measured by the School Burnout Inventory total score	Self-report questionnaire assessing burnout	baseline (day 0) and post-intervention (day 10)
Primary	Change in stress, as measured by the Perceived Stress Scale total score	Self-report questionnaire assessing stress	baseline (day 0) and post-intervention (day 10)
Secondary	Change in mastery, as measured by the Pearlin Personal Mastery Scale total score	Self-report questionnaires assessing mastery	baseline (day 0) and post-intervention (day 10)
Secondary	Change in avoidance, as measured by the Brief Experiential Avoidance Questionnaire total score	Self-report questionnaires assessing avoidance	baseline (day 0) and post-intervention (day 10)
Secondary	Change in mood, as measured by the Positive and Negative Affect Schedule total scores for Positive and Negative Affect	Self-report questionnaire assessing mood	baseline (day 0) and post-intervention (day 10)
Secondary	Change in reward, as measured by the Environmental Reward Observation Scale total score	Self-report questionnaires assessing environmental reward	baseline (day 0) and post-intervention (day 10)
Secondary	Change in behavioral activation, as measured by the Activation sub-scale of the Behavioral Activation for Depression Scale	Self-report questionnaires assessing behavioral activation	baseline (day 0) and post-intervention (day 10)
Secondary	Change in functional impairment, as measured by the Modified Work and Social Adjustment Scale total score	Self-report questionnaire assessing functional impairment	baseline (day 0) and post-intervention (day 10)
Secondary	Change in quality of life, as measured by the WHOQOL-BREF total score	Self-report questionnaire assessing quality of life	baseline (day 0) and post-intervention (day 10)
Secondary	Change in depression symptoms, as measured by the General Depression scale of the Inventory of Depression and Anxiety Symptoms	Self-report questionnaire assessing depression symptoms	baseline (day 0) and post-intervention (day 10)
Secondary	Change in mastery, as measured by the average of the daily Importance ratings of activities (0-10) on the Daily Activities Monitoring Form	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)
Secondary	Change in avoidance, as measured by the total score of the Avoidance/Rumination sub-scale of the Behavioral Activation for Depression Scale	Self-report questionnaire assessing avoidance and rumination	baseline (day 0) and post-intervention (day 10)
Secondary	Change in environmental reward, as measured by the average of the daily Pleasure ratings of activities (0-10) on the Daily Activities Monitoring Form	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)