Clinical trial NCT04064372: Mindful Response to Adversity: A Brief Stress Resilience Training
Official title: Mindful Response to Adversity: A Brief Stress Resilience Training for Improving Mental Health in Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Depression
Keywords: Mindfulness
Resilience
Equanimity
Inflammation
Wise Intervention
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will conduct an intervention study with the aim of improving stress resilience and mental health outcomes in at-risk freshman students. Participants will attend a group training session, led by a professional instructor, about responding to adversity, which will include a description of the skills, a writing and sharing activity focused on the proposed approach, and a practice session. Following the training, participants will be instructed to practice the skills that the participants just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G).

Detailed description: The investigators will conduct an intervention study with the aim of improving stress resilience and mental health outcomes in at-risk freshman students. The investigators will also work closely with institutional officials to assess whether the intervention can improve student well-being. Specifically, the project aims to teach freshman students (who are at high risk for depression) skills in how to foster a mindful response to adversity at the beginning of the school term, along with periodic support reminders (via text message) during high stress/vulnerability periods over the course of the semester. The investigators will adopt a randomized controlled trial approach to rigorously evaluate whether this intervention can be adopted as a standard onboarding program for all incoming freshman students during the first weeks of orientation on the CMU campus. Participants will come for the study session and provide a dried blood spot sample and complete a battery of self-report questionnaires.

Participants will attend a group training session, led by a professional instructor, about responding to adversity, which will include a description of the skills, a writing and sharing activity focused on the proposed approach, and a practice session. Following the training, participants will be instructed to practice the skills that the participants just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G). Salivary cortisol measures will be collected throughout the TSST-G.

The treatment condition will be trained in techniques designed to teach a "mindful approach to adversity". These techniques will include: normalizing, attention, equanimity, non-judgment, de-centering, accepting of experiences, and impermanence. Participants will be instructed on the mindset, asked to write about an instance of non-judgment and share with a partner, and then guided through a short training designed to practice each skill.

The control condition will be trained in techniques designed to teach a typical narrative self-analysis / strengths-based approach to adversity. These techniques will include: choosing the best approach, minimizing stress, and identifying and enhancing personal strengths. Participants will be instructed on the mindset, asked to write about an instance of personal strength and share with a partner, and then guided through a short training designed to practice each skill.

Daily diary measures will be collected for 7 days following the study session and 1 week before the follow-up session. Microhit boosters will be sent to participants at self-identified high stress periods, which remind participants of the training session skills.

Participants will come for the follow-up session and provide a dried blood spot sample and complete a battery of self-report questionnaires.

Eligibility criteria: Inclusion Criteria:

* Full-time first-year student at Carnegie Mellon University.
* Adult (age 18+)
* Must own a data-enabled smartphone
* Scores indicating moderate to high levels of depressive symptomatology (composite score \> or equal to 2 on the short-form (6-item) Beck Depression Inventory).

Exclusion Criteria:

* Potential participants who score a 0 or a 1 on the 6-item BDI section will not be eligible.

Primary outcomes:
measure: Daily Depression
timeFrame: Change in daily depression assessed daily for seven days during week 2 and week 16 of the study.
measure: Depression I
timeFrame: Change in depression over 4-month period.
measure: Depression II
timeFrame: Change in depression over 4-month period.
measure: Daily Social Connection
timeFrame: Change in daily social connection assessed daily for seven days during week 2 and week 16 of the study.
measure: Daily Belonging
timeFrame: Change in loneliness over 4-month period.
measure: Loneliness
timeFrame: Change in loneliness over 4-month period.
Secondary outcomes:
measure: Academic performance
timeFrame: Change in GPA between semester immediately prior to enrollment and semester during enrollment in the study (approximately 5 months).
measure: Occurrences of Daily Acceptance
timeFrame: Assessed daily for seven days during week 2 and week 16 of the study.
measure: Physical Activity (FitBit)
timeFrame: Assessed daily during week 2-17 of the study.
measure: Sleep (FitBit)
timeFrame: Assessed daily during week 2-17 of the study.
measure: Concentrations of pro-inflammatory gene expression
timeFrame: Change in gene expression over weeks 1 and weeks 17 of the study.
measure: Concentrations of C-Reactive Protein
timeFrame: Change in CRP over 4-month period.
measure: Concentrations of salivary cortisol
timeFrame: Four cortisol samples will be collected at the baseline session. One sample before and three samples after the acute stress challenge using the TSST.
measure: Perceived Stress
timeFrame: Change in perceived stress over 4-month period.
measure: Subjective Social Status
timeFrame: Measured at baseline only.
measure: Daily Resilience using the Brief Resilience Scale
timeFrame: Assessed daily for seven days during week 2 and week 16 of the study.
measure: Daily Occurrence of Stress and Successful Coping Scale
timeFrame: Assessed daily for seven days during week 2 and week 16 of the study.
measure: Daily State Mindfulness Scale
timeFrame: Assessed daily for seven days during week 2 and week 16 of the study.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
References:
citation: Kunzler AM, Helmreich I, Konig J, Chmitorz A, Wessa M, Binder H, Lieb K. Psychological interventions to foster resilience in healthcare students. Cochrane Database Syst Rev. 2020 Jul 20;7(7):CD013684. doi: 10.1002/14651858.CD013684.