Stress, PsychologicalNCT02954965
Brief Mood Enhancement Intervention
A study testing Reward and Approach in people with Stress, Psychological and Burnout, Professional, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Burnout, Professional
- What is being tested?
- Reward and Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: 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.
- Conditions
- Stress, Psychological, Burnout, Professional
- Being tested
- Reward, Approach
- Keywords
- graduate student, burnout, stress, mood
- Medical subject headings
- Stress, Psychological, Burnout, Professional, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RewardBehavioural
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.
ApproachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Reward | Experimental | A brief, phone-administered intervention designed to help graduate students increase the number of pleasant and rewarding activities in their daily lives. Receives: Behavioral: Reward |
| Approach | Experimental | A brief, phone-administered intervention designed to help graduate students block procrastination and avoidance and to approach important activities they are currently avoiding. Receives: Behavioral: Approach |
| Monitoring | No intervention | Participants will monitor their current behaviors, mood, and burnout with no directed intervention to change behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in burnout, as measured by the School Burnout Inventory total score
Self-report questionnaire assessing burnout
Measured: baseline (day 0) and post-intervention (day 10)
Change in stress, as measured by the Perceived Stress Scale total score
Self-report questionnaire assessing stress
Measured: baseline (day 0) and post-intervention (day 10)
Secondary outcomes (11)
Change in mastery, as measured by the Pearlin Personal Mastery Scale total score
Self-report questionnaires assessing mastery
Measured: baseline (day 0) and post-intervention (day 10)
Change in avoidance, as measured by the Brief Experiential Avoidance Questionnaire total score
Self-report questionnaires assessing avoidance
Measured: 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
Self-report questionnaire assessing mood
Measured: baseline (day 0) and post-intervention (day 10)
Change in reward, as measured by the Environmental Reward Observation Scale total score
Self-report questionnaires assessing environmental reward
Measured: 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
Self-report questionnaires assessing behavioral activation
Measured: baseline (day 0) and post-intervention (day 10)
Change in functional impairment, as measured by the Modified Work and Social Adjustment Scale total score
Self-report questionnaire assessing functional impairment
Measured: baseline (day 0) and post-intervention (day 10)
Change in quality of life, as measured by the WHOQOL-BREF total score
Self-report questionnaire assessing quality of life
Measured: 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
Self-report questionnaire assessing depression symptoms
Measured: 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
Self-report monitoring form describing activities during the day, how enjoyable they were, and how important they were
Measured: 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
Self-report questionnaire assessing avoidance and rumination
Measured: 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
Self-report monitoring form describing activities during the day, how enjoyable they were, and how important they were
Measured: baseline (days 0-3) and intervention (days 3-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954965
- Sponsor's protocol ID
- PRO00074337
- Status last verified
- Feb 2018
- First submitted
- 30 Sep 2016
- Last updated
- 23 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Mood Among Graduate Students: Evaluation of a Brief, Phone-Administered Behavioral Intervention
- ClinicalTrials.gov ID
- NCT02954965
- Acronym / sponsor ID
- PRO00074337
- Conditions
- Stress, Psychological, Burnout, Professional
- Keywords
- graduate student, burnout, stress, mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reward | Experimental | Behavioral: RewardA brief, phone-administered intervention designed to help graduate students increase the number of pleasant and rewarding activities in their daily lives. |
| Approach | Experimental | Behavioral: ApproachA brief, phone-administered intervention designed to help graduate students block procrastination and avoidance and to approach important activities they are currently avoiding. |
| Monitoring | No intervention | –Participants will monitor their current behaviors, mood, and burnout with no directed intervention to change behavior |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RewardBrief 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. | Behavioural | Reward |
| ApproachBrief 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. | Behavioural | Approach |
Primary outcome
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
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
11 secondary outcomes
Change in mastery, as measured by the Pearlin Personal Mastery Scale total score
Time frame: 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)
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)
Change in reward, as measured by the Environmental Reward Observation Scale total score
Time frame: 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)
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)
Change in quality of life, as measured by the WHOQOL-BREF total score
Time frame: 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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
Related trials for Stress, Psychological
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Not yet recruiting
Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Endometriosis, Quality of Life
Not yet recruiting
Mobile-Based Resilience Intervention for Moral Injury, Compassion Fatigue, and Distress in ICU Nurses
Moral Injury
Not yet recruiting
Group Cognitive Processing Therapy for Women Survivors of Gender-Based Violence: Feasibility Study
Trauma, Psychological, Traumatic Stress Disorder
Not yet recruitingObservational study
Relationship of Forward Head Posture With Burnout and Quality of Life
Forward Head Posture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reward and Approach in people with Stress, Psychological and Burnout, Professional, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in burnout, as measured by the School Burnout Inventory total score (time frame: baseline (day 0) and post-intervention (day 10)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.