Mindful Response to Adversity: A Brief Stress Resilience Training

NCT04064372 | Completed

• 1 other identifier: 182R07SM
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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).

Conditions

Loneliness; Depression

Keywords

Mindfulness; Resilience; Equanimity; Inflammation; Wise Intervention

Outcome Measures

Primary Outcomes (6)

• Daily Depression

  In a daily diary, participants are asked at the end of the day to identify the extent to which they endorse symptoms measuring depressive symptomatology (i.e. "feeling hopeless about the future", "feeling blue") for that day. Analyses will use multilevel modeling to test for a time by condition interaction showing lower daily depressive symptomatology at post-treatment in the equanimity compared to the strength based group.

  Change in daily depression assessed daily for seven days during week 2 and week 16 of the study.

• Depression I

  Evaluated using the validated 21-item Beck Depression Inventory (BDI), which is designed to measure characteristic attitudes and symptoms of depression. The score for each item ranges between 0-3, where 0 denotes less depression (e.g. "I do not feel sad") and 3 denotes more depression (e.g. "I am so dan and unhappy that I can't stand it"). Total score will be between 0-63, where 0 indicates no depression and 63 indicates extreme depression. The score is a total of 21 questions and the following is a typical subscale range distribution: 1-10: These ups and downs are considered normal 11-16: Mild mood disturbance 17-20: Borderline clinical depression 21-30: Moderate depression 31-40: Severe depression over 40: Extreme depression Analyses will use multilevel modeling to test for a time by condition interaction showing lower depressive symptomatology at post-treatment in the equanimity compared to the strength based treatment group.

  Change in depression over 4-month period.

• Depression II

  Evaluated using the validated 20-item Center for Epidemiologic Studies Depression scale (CES-D), which is designed to measure characteristic attitudes and symptoms of depression. There are 20 questions and the score for each item ranges between 0-3. For most questions, a lower score indicates lack of depression and a higher score indicates high depression (e.g. in response to the statement "I felt fearful" a 0 indicates rarely and 3 indicates most or all of the time). Questions 4, 8, 12, and 16 are reverse scored. The score is the sum of the 20 questions. Possible range is 0-60. A score of 16 points or more is considered depressed. Analyses will use multilevel modeling to test for a time by condition interaction showing lower depressive symptomatology at post-treatment in the equanimity compared to the strength based treatment group.

  Change in depression over 4-month period.

• Daily Social Connection

  Following Hawkley et al. (2007) and our previous studies, end-of-day daily diary questions will assess the amount of time spent interacting with others and the extent to which social interactions throughout the day were perceived as positive. Example items: "How much time did you spend today with others, talking or listening to them?" (0 = little or none of the day to 4 = most or all of the day) and "How many positive interactions did you have today (e.g., supportive, enjoyable, rewarding, affirming)?" (0 = one, 1 = several, 2 = many). Analyses will use multilevel modeling to test for a time by condition interaction showing increased daily social connection at post-treatment in the equanimity compared to the strength based group.

  Change in daily social connection assessed daily for seven days during week 2 and week 16 of the study.

• Daily Belonging

  End-of-day daily diary questions will measure feelings of belonging and closeness at school. Example items: "I felt like I belong in school" and "I felt like no one really knew me well at school (reverse-scored)" (0= Not at all, 4= Extremely). Analyses will use multilevel modeling to test for a time by condition interaction showing increased daily social belonging at post-treatment in the equanimity compared to the strength based group.

  Change in loneliness over 4-month period.

• Loneliness

  Evaluated using the University of California, Los Angeles (UCLA) Loneliness Scale. The University of California, Los Angeles (UCLA) Loneliness scale is designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as either A ("I always feels this way"), O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"). Scores are summed from each item and higher scores indicate greater degrees of loneliness. Scores of 15-20 indicate average level of loneliness; 21-30 indicate frequent loneliness; 31-40 indicate severe loneliness. Analyses will use multilevel modeling to test for a time by condition interaction showing decreased loneliness at post-treatment in the equanimity compared to the strength based group.

  Change in loneliness over 4-month period.

Secondary Outcomes (12)

• Academic performance

  Change in GPA between semester immediately prior to enrollment and semester during enrollment in the study (approximately 5 months).

• Occurrences of Daily Acceptance

  Assessed daily for seven days during week 2 and week 16 of the study.

• Physical Activity (FitBit)

  Assessed daily during week 2-17 of the study.

• Sleep (FitBit)

  Assessed daily during week 2-17 of the study.

• Concentrations of pro-inflammatory gene expression

  Change in gene expression over weeks 1 and weeks 17 of the study.

Study Arms (2)

Mindful Response to Adversity

EXPERIMENTAL

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.

Behavioral: Mindful response to adversity brief training

Strength-based approach to adversity

ACTIVE COMPARATOR

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.

Behavioral: Strengths-based response to adversity brief training

Interventions

Mindful response to adversity brief training 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).

Mindful Response to Adversity

Strengths-based response to adversity brief training 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).

Strength-based approach to adversity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Carnegie Mellon University: lead

Study Sites (1)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 32691879 DERIVED

MeSH Terms

Conditions

Depression; Inflammation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: August 21, 2019
• Study Start: August 26, 2019
• Primary Completion: December 13, 2019
• Study Completion: December 13, 2019
• Last Updated: March 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)