NCT04144400

Brief Summary

The study is designed to compare the efficacy of a simple, non-spiritual, self-management strategy that can strengthen personal and occupational resources-resources that can positively impact adverse reactions to military-specific demands and promote personal and work outcomes. Our app-based intervention, designed to strengthen a balanced self-identity through affirmation of growth and balance values, will be adapted to military occupational contexts, utilizing an existing self-management strategy (QE) to a military occupational context to maximize it effectiveness in strengthening participants' balanced sense of self, which we expect to have positive benefit on personal and work outcomes in military service members.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2019

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 11, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

October 1, 2019

Last Update Submit

January 13, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Quiet Ego

    Change between baseline and five weeks, the Quiet Ego Scale (QES; Wayment, Bauer, \& Sylaska, 2014) will be used to assess an identity that strikes a balance between a strong sense of agency (but not egoism) and a strong concern for the welfare of others. The QES is comprised of 14 items arranged in a 5-point Likert-type format with responses ranging from 1 (Strongly disagree) to 5 (Strongly agree). Sample items include: "I try to look at everybody's side of a disagreement before I make a decision" and "for me, life has been a continuous process of learning, changing, and growth." Higher scores on the QES indicate a stronger quiet ego. The QES has been found to have adequate internal validity (α = .76 to .78; (Wayment et al., 2014).

    Baseline, 5 weeks

  • Self-Image

    The self-image and compassionate goals scale developed by Crocker and Canevello (2008) will be used to assess the change in self-image between baseline and five weeks. The scale is comprised of 13 items total with six items assessing self-image goals. The scale is arranged in a 5-point Likert-type format with responses ranging from 1 (Almost never) to 5 (Always). All items begin with the phrase, "In the past week, in the area of friendships, how much did you want to or try to..." Six of the items assess self-image goals such as, "get others to recognize or acknowledge your positive qualities" and "avoid taking risks or making mistakes." Higher scores for the self-image subscale represents a higher endorsement of self-image.

    Baseline, 5 weeks

  • Compassioante Goals

    The self-image and compassionate goals scale developed by Crocker and Canevello (2008) will be used to assess the change in compassionate goals between baseline and five weeks. The scale is comprised of 13 items total with seven items assessing compassionate goals. The scale is arranged in a 5-point Likert-type format with responses ranging from 1 (Almost never) to 5 (Always). All items begin with the phrase, "In the past week, in the area of friendships, how much did you want to or try to..." Seven items asses compassionate goals such as, "be supportive of others" and "make a positive difference in someone else's life." Higher scores for the compassionate goals subscale represents a higher endorsement of compassionate goals.

    Baseline, 5 weeks

Secondary Outcomes (12)

  • Spiritual Fitness

    Baseline, 5 weeks

  • Positive and Negative Affect Schedule

    Baseline, 5 weeks

  • High Risk Demands

    Baseline, 5 weeks

  • Traditional Occupational Demands

    Baseline, 5 weeks

  • Work Overload

    Baseline, 5 weeks

  • +7 more secondary outcomes

Other Outcomes (10)

  • Resilience to Adverse Events

    Baseline, 5 weeks

  • Aggression

    Baseline, 5 weeks

  • Physiological-based stress

    Baseline, 5 weeks

  • +7 more other outcomes

Study Arms (2)

BRAVE Group

EXPERIMENTAL

The BRAVE program aims to examine the effectiveness of an intervention strategy designed to increase personal and work outcomes through the strengthening of quiet ego characteristics. The BRAVE intervention (delivered over four weeks) will ask study participants to use the app each week, with specific instructions on selecting one section each week and first listening to the longer version and reflect. At least two other times during the week they will be asked to listen to a recording of their choice on the same topic. On the final week (week 5) all participants (experimental and control) will return to the lab to complete post-study assessment tools (SART, post-study on-line questionnaire, provide a urine sample, and weight measurement).

Behavioral: Direction Check App

Time Management Group

ACTIVE COMPARATOR

The time management program aims to examine the effectiveness of an intervention strategy designed to increase personal and work outcomes through the strengthening of time management characteristics. The time management intervention (delivered over four weeks) will ask study participants to use the time management version of the app each week, with specific instructions on selecting one section each week and first listening to the longer version and reflect. At least two other times during the week they will be asked to listen to a recording of their choice on the same topic. On the final week (week 5) all participants (experimental and control) will return to the lab to complete post-study assessment tools (SART, post-study on-line questionnaire, provide a urine sample, and weight measurement).

Behavioral: Direction Check App (Time Management Version)

Interventions

Direction Check is a simple, inexpensive app that builds resilience through balanced values to target the everyday personal and occupational stressors faced by military populations.

BRAVE Group

Direction Check (Time Management Version) is a simple, inexpensive app that builds resilience through time management exercises to target the everyday personal and occupational stressors faced by military populations.

Time Management Group

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All participants in the study will include males and females between the ages of 17-70 years. Participants of all racial and ethnic backgrounds will be eligible to participate. Participants of all religious and spiritual orientations will be eligible to participate. Participants must be active-duty military personnel.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ann Huffman, PhD

    Northern Arizona University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 30, 2019

Study Start

February 11, 2020

Primary Completion

August 1, 2020

Study Completion

November 1, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share