Mindful Response to Adversity: A Brief Stress Resilience Training

NCT ID: NCT04064372

Last Updated: 2020-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-26

Study Completion Date

2019-12-13

Brief Summary

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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

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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.

Conditions

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Loneliness Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcomes assessor will remain masked to which program the participant will use. However the experimenter will engage with participants while in their training groups and thus will not be masked to condition.

Study Groups

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Mindful Response to Adversity

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.

Group Type EXPERIMENTAL

Mindful response to adversity brief training

Intervention Type BEHAVIORAL

Participants will attend a group training session, led by a professional instructor, about responding to adversity with an approach of mindfulness, equanimity, and non-judgment, 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 they just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G).

Strength-based approach to adversity

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.

Group Type ACTIVE_COMPARATOR

Strengths-based response to adversity brief training

Intervention Type BEHAVIORAL

Participants will attend a group training session, led by a professional instructor, about responding to adversity with an approach of strengths-based, narrative self-analysis, 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 they just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G).

Interventions

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Mindful response to adversity brief training

Participants will attend a group training session, led by a professional instructor, about responding to adversity with an approach of mindfulness, equanimity, and non-judgment, 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 they just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G).

Intervention Type BEHAVIORAL

Strengths-based response to adversity brief training

Participants will attend a group training session, led by a professional instructor, about responding to adversity with an approach of strengths-based, narrative self-analysis, 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 they just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carnegie Mellon University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Carnegie Mellon University

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32691879 (View on PubMed)

Other Identifiers

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182R07SM

Identifier Type: -

Identifier Source: org_study_id

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