Well-beingNCT04144400
Psychological Health in Military Personnel
A study testing Direction Check App and Direction Check App (Time Management Version) in people with Well-being, run by Northern Arizona University.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Well-being
- What is being tested?
- Direction Check App and Direction Check App (Time Management Version)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2020to Nov 2020
- 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 17 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Psychological Health in Military Personnel: Phase III
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.
- Conditions
- Well-being
- Being tested
- Direction Check App, Direction Check App (Time Management Version)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direction Check AppBehavioural
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.
Direction Check App (Time Management Version)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Direction Check App (Time Management Version) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Baseline, 5 weeks
Secondary outcomes (12)
Spiritual Fitness
Change between baseline and five weeks, the Spiritual Fitness Scale (SFS; Hammer, Cragun, \& Hwang, 2013) will be used to assess the degree to which an individual has a sense of meaning, purpose, and accomplishment in their life that extends beyond the self (Peterson et al., 2011). The SFS is comprised of five items arranged in a 5-point Likert-type format with responses ranging from 1 (Not like me at all) to 5 (Very much like me). Sample items include: "I have a core of beliefs, ethics, and values that give my life a sense of meaning and purpose" and "The work I am doing in the military is meaningful to me." Higher scores on the SFS indicate a greater capacity to identify one's core self, access resources that facilitate the realizing of the core self and strivings, and experience a sense of connectedness with people and the world (i.e., spiritual fitness). The SFS has been found to have adequate internal consistency (α = .77; Hammer et al., 2013).
Measured: Baseline, 5 weeks
Positive and Negative Affect Schedule
Change between baseline and five weeks, the positive and negative affect schedule (I-PANAS-SF; Thompson, 2007) will be used to assess positive and negative affect. The I-PANAS-SF is comprised of 10 items arranged in a 5-point Likert-type format with responses ranging from 1 (Very slightly or not at all) to 5 (Very much). Five items of the scale measure positive affect while the other five items measure negative affect. Respondents are asked to rate these positive and negative adjectives according to the extent to which each describes the way they have felt during the past week. Sample positive affect items include 'attentive', while sample negative affect items include 'upset'. Higher scores on both positive affect or negative affect indicate a tendency to experience a positive and negative mood. Both subscales (positive affect and negative affect) have been found to have adequate internal consistency (positive affect: α = .78; negative affect: α = .76; Thompson, 2007).
Measured: Baseline, 5 weeks
High Risk Demands
Change between baseline and five weeks, a scale developed by Castro and Adler (2000) will be used to assess high-risk demands among respondents. The scale is comprised of seven items with short answer responses. Sample items include: "In the past week, how many hours of work have you average per day?" and "How many days have you been on a training exercise in the past 6 months?"
Measured: Baseline, 5 weeks
Traditional Occupational Demands
Change between baseline and five weeks, the Organizational Constraints Scale (OCS; Spector \& Jex, 1998) will be used to assess the ability of individuals to perform their jobs given their occupational demands. The OCS is comprised of 11 items arranged in a 5-point Likert-type format with responses ranging from 1 (Never) to 5 (Several times per day). Respondents are first asked to indicate how often it is difficult or impossible to do his or her job because of the listed items. Sample items include: "poor equipment or supplies," "inadequate training," and "interruptions by other people." Higher scores on the OCS indicate a high level of organizational constraints. The OCS has been found to have adequate internal consistency (α = .85; Spector \& Jex, 1998).
Measured: Baseline, 5 weeks
Work Overload
Change between baseline and five weeks, a shortened version of the overload subsection of the Michigan Organizational Assessment Questionnaire (MOAQ; Cammann, Fichman, Jenkins, \& Klesh, 1983) will be used to assess work overload. The shortened MOAQ being utilized is comprised of three items arranged in a 7-point Likert-type format with responses ranging from 1 (Strongly disagree) to 7 (Strongly agree). Sample items include: "I never seem to have enough time to get everything" and "I have too much work to do to do everything well." One item is reverse-coded. Higher scores on the MOAQ and the overload subsection indicate greater work overload.
Measured: Baseline, 5 weeks
Coping
Change between baseline and five weeks, the Emotion Regulation Questionnaire (ERQ; Gross, John, \& Diener, 2003) will be used to assess participant's coping methods and ability among two common emotional regulation strategies - cognitive reappraisal and expressive suppression. The ERQ is comprised of 10 items total; six items which asses cognitive reappraisal and four items that assess expressive suppression. Each item is arranged in a 7-point Likert-type format with responses ranging from 1 (Strongly disagree) to 7 (Strongly agree). Sample items include: "When I want to feel more positive emotion (such as joy or amusement), I change what I am thinking about" and "I control my emotions by not expressing them." Higher scores in each subsection (reappraisal and suppression) indicate a higher tendency for respondents to use the related emotional regulation strategies. The ERQ has been found to have adequate internal consistency (α = .68 to .76; Gross et al., 2003).
Measured: Baseline, 5 weeks
Self-Compassion
Change between baseline and five weeks, the Self-Compassion Scale (SCS; Raes, Pommier, Neff, \& Van Gucht, 2011) will be used to assess the ability to extend compassion to the self. The SCS is comprised of 12 items and six subscales, each measuring a different component of self-compassion. Each item is arranged in a 5-point Likert-type format with responses ranging from 1 (Almost never) to 5 (Almost always). Sample items include: "When I fail at something important to me I become consumed by feelings of inadequacy" and "I try to see my failings as part of the human condition." Higher subscale scores on the SCS indicate greater endorsement of the related component of self-compassion. The SCS has been found to have adequate internal consistency (α = .86; Raes et al., 2011).
Measured: Baseline, 5 weeks
Family Functioning
Change between baseline and five weeks, an adapted version of the Self-Report Measures of Family Functioning (SRMFF; Bloom, 1985) will be used to assess family functioning among two dimensions: family cohesion and family conflict. The SRMFF is comprised of 10 items total, five items relating to the dimension of cohesion and the other five items relating to the dimension of conflict. Respondents are asked to think about their family-life over the past week; each item is arranged in a 5-point Likert-type format with responses ranging from 1 (Strongly disagree) to 5 (Strongly agree). Sample items relating to the dimension of cohesion include: "Family members really helped and supported one another" and "We really got along well with each other." Sample items relating to the dimension of conflict include: "We fought a lot in our family" and "Family members sometimes hit each other. Items 3 and 5 in both the dimensions of family cohesion and family conflict are reverse-coded.
Measured: Baseline, 5 weeks
Work-Family Conflict
Change between baseline and five weeks, a shortened Work-Family Conflict Scale (WFSC; Carlson, Kacmar, \& Williams, 2000) will be used to assess interrole conflict. The shortened WFSC being utilized is comprised of 12 items total; three items which assess time-based work interference with family, three items which assess time-based family interference with work, three items which assess strain-based work interference with family, and three items that assess strain-based family interference with work. Each item is arranged in a 5-point Likert-type format with responses ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Sample items include: "My work keeps me from my family activities more than I would like" and "Due to stress at home, I am often preoccupied with family matters at work."
Measured: Baseline, 5 weeks
Personal Resources
Change between baseline and five weeks, an adapted version of a social support and social strain survey developed by Wayment and Brookshire (2017) will be used to assess personal resources. The shortened version of the survey is comprised of six items arranged in a 5-point Likert-type format with responses ranging from 1 (Never) to 5 (All the time). Respondents are first asked to think about the "most important" person in their social network and are then asked about how often that person engaged in specific types of responses in the previous week. Sample items include: "listen to you when you wanted to talk". Higher scores for the social support questions indicate higher levels of social support. Higher scores for the social strain questions indicate higher levels of social strain. The survey has been found to have adequate internal consistency (social support: α = .89; social strain: α = .80; Wayment \& Brookshire, 2017).
Measured: Baseline, 5 weeks
Military Pride
Change between baseline and five weeks, three items adapted from a soldier will survey created by Marlowe, Furukawa, Griffith, Ingraham, and Kirkland (1985) will be used to assess military pride. The three items are arranged in a 5-point Likert-scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Sample items include: "I am proud to be in the Army" and "What I do in the Army is worthwhile." Higher scores on the survey indicate greater military pride.
Measured: Baseline, 5 weeks
Environment Life
Change between baseline and five weeks, a scale developed by Huffman, Adler, Castro, and Dolan (2000) will be used to assess environmental life among respondents. The scale is comprised of five items arranged in a 5-point Likert-type format with responses ranging from 1 (Never) to 5 (Always). Sample items include: "I know what duty I will be doing day to day" and "I have a predictable mission schedule."
Measured: Baseline, 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start11 Feb 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-beingStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Huffman, PhD, Principal investigator, Northern Arizona University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144400
- Sponsor's protocol ID
- 1432388-2
- Status last verified
- Jan 2020
- First submitted
- 1 Oct 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Health in Military Personnel: Phase III
- ClinicalTrials.gov ID
- NCT04144400
- Acronym / sponsor ID
- 1432388-2
- Conditions
- Well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Study start
- 11 Feb 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 30 Oct 2019 (actual)
- 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRAVE Group | Experimental | Behavioral: Direction Check AppThe 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). |
| Time Management Group | Active comparator | Behavioral: Direction Check App (Time Management Version)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). |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Direction Check AppDirection Check is a simple, inexpensive app that builds resilience through balanced values to target the everyday personal and occupational stressors faced by military populations. | Behavioural | BRAVE Group |
| Direction Check App (Time Management Version)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. | Behavioural | Time Management Group |
Primary outcome
Quiet Ego
Time frame: Baseline, 5 weeks
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).
Self-Image
Time frame: Baseline, 5 weeks
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.
Compassioante Goals
Time frame: Baseline, 5 weeks
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.
12 secondary outcomes
Spiritual Fitness
Time frame: Baseline, 5 weeks
Positive and Negative Affect Schedule
Time frame: Baseline, 5 weeks
High Risk Demands
Time frame: Baseline, 5 weeks
Traditional Occupational Demands
Time frame: Baseline, 5 weeks
Work Overload
Time frame: Baseline, 5 weeks
Coping
Time frame: Baseline, 5 weeks
Self-Compassion
Time frame: Baseline, 5 weeks
Family Functioning
Time frame: Baseline, 5 weeks
Work-Family Conflict
Time frame: Baseline, 5 weeks
Personal Resources
Time frame: Baseline, 5 weeks
Military Pride
Time frame: Baseline, 5 weeks
Environment Life
Time frame: Baseline, 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Ann Huffman, PhD principal investigator
Northern Arizona University
Questions about this trial
What is this clinical trial studying?
A study testing Direction Check App and Direction Check App (Time Management Version) in people with Well-being, run by Northern Arizona University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chris Farkas, BS (928-523-5137, Christopher.Farkas@nau.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quiet Ego (time frame: Baseline, 5 weeks). The study lists 3 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 18 Jan 2020.