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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-22-2-0085 | Other Identifier | United States Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The goal of this clinical trial is to learn if a treatment designed to deal with anger and aggression from a past betrayal will work. The study will be done on active duty military service members and veterans aged 18 or older. The main questions it aims to answer are:
Researchers will compare differences in groups that have different wait times (2-, 3-, or 4-weeks).
Participants will complete surveys before, during and after the treatment. The treatment will be 14 modules given twice a week. About 1 month after treatment ends, surveys will be taken again.
Participants will undergo the study procedures described below. The preferred method of assessment and treatment is face-to-face in the STRONG STAR offices at Fort Cavazos. However, there may be circumstances when participants can complete the treatment through telebehavioral health (i.e., by phone or using a HIPAA-compliant video calling platform like Zoom). Decisions will be made on a case-by-case basis as issues arise for individuals (e.g., childcare) and in discussion with the treatment team. If participants do not have internet access they may need to complete assessments in person at the STRONG STAR office or by phone.
During the wait time:
During treatment:
For follow-up:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-week wait time group | Experimental | This group is randomized to a 2-week wait time prior to treatment with CART |
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| 3-week wait time group | Experimental | This group is randomized to a 3-week wait time prior to treatment with CART |
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| 4-week wait time group | Experimental | This group is randomized to a 4-week wait time prior to treatment with CART |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Countering Chronic Anger and Aggression Related to Trauma and Transgressions (CART) | Behavioral | Countering Chronic Anger and Aggression Related to Trauma and Transgressions (CART), a novel intervention for reducing chronic anger and aggression and improving interpersonal relationships, in military personnel who have experienced military-related betrayal delivered in 14 treatment modules twice a week. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful recruitment | Number of eligible referrals that are recruited, enrolled into the study and randomized to treatment | Study start to last subject enrolled, approximately 1 year |
| Client satisfaction survey (CSQ-8) | The survey will assess participant acceptability using the CSQ-8, an 8-item self-report measure designed to assess client satisfaction. Each question is answered on a 4-point scale with a possible range of scores between 8-32. A higher score indicates a higher level of overall satisfaction. Mean scores will be used to determine participant satisfaction. | 1 month after study end ( at approximately 11-18 weeks) |
| Overt Aggression Scale-Modified (OAS-M) | A 17-item measure that assesses frequency of different aggression acts in outpatient settings, including verbal and physical aggression against self, other, and objects. The OAS-M is scored by summing the instances of aggression since the last assessment. The OAS-M had been administered as an interview as well as self-report and will be administered as a self-report in this study, consistent with past aggression research with veterans (Miles, Kent et al., 2020). The score is calculated using a sum total of all instances of aggression. Higher scores indicate a greater frequency of aggressive behaviors. | Baseline to 1 month post treatment (approximately 11-18 weeks) |
| Inventory of Interpersonal Problems-Short Version (IIP-32) | A 32-item self-report assessment designed to measure interpersonal functioning. Items are scored on a five-point scale from 0 (not at all) to 4 (extremely) in response to the stem: "How much have you been distressed by this problem?" There are 8 factors and a total score. The 8 factors are: hard to be assertive, hard to be sociable, hard to be supportive, too dependent, too caring, too aggressive, hard to be involved and too open. The possible total score ranges from a T-score are 0-100. T-scores that are higher than 60 are above average and T-scores 70 or higher suggest significant interpersonal difficulty. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of protocol completion | The 14 modules may be completed within a 7-14 week time period by each participant. | Treatment end (Approximately 7-14 weeks) |
| Number of modules completed | A count of how many of the 14 modules are completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanessa Jacoby, PhD | Contact | (254) 289-3468 | jacobyv@uthscsa.edu | |
| Alan Peterson, PhD | Contact | (210) 562-6700 | petersona3@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vanessa Jacoby, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Alan Peterson, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carl R. Darnall Army Medical Center (CRDAMC) at Fort Cavazos | Recruiting | Fort Cavazos | Texas | 76554 | United States |
At the conclusion of the study all data will be stripped of identifiers. De-identified (anonymized) data will be maintained indefinitely in the STRONG STAR Repository. Identifiable data from participants who signed the consent to have their data placed in the STRONG STAR Repository will be maintained under the UTHSCSA IRB-approved Repository protocol indefinitely.
At the conclusion of the study and after data are analyzed.
Researchers who are interested in IPD should contact STRONG STAR at https://www.strongstar.org/contact/
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| ID | Term |
|---|---|
| D000374 | Aggression |
| ID | Term |
|---|---|
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
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Upon enrollment into the study, participants will begin with a minimal contact wait condition followed by randomization to different wait times (2-, 3-, or 4-weeks)
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| Baseline to 1 month post treatment (approximately 11-18 weeks) |
| State Trait Anger Expression Inventory-2 (STAXI-2) | A 57-item inventory which measures the frequency and intensity of anger as an emotional state. There are 6 scales, 5 subscales, and an Anger Expression Index (total anger expression). The State Anger scale (15 items) measures anger intensity as a momentary emotional state, while the Trait Anger scale (10 items) measures the disposition to experience angry feelings as a personality-like trait over lengthy time periods (i.e., the individual's disposition to become angry or angry temperament). The Anger Expression scale (16 items) and the Anger Control scale (16 items) measure four anger-related trait dimensions. Ratings of items are on a 4-point response scales that measure state anger (intensity) as well as trait anger (frequency). The possible total range is a T-score from 0 to 100. Individuals with anger scores higher than the 75-percentile experience and/ or express angry feelings to a degree that may interfere with optimal functioning. | Baseline to 1 month post treatment (approximately 11-18 weeks) |
| Baseline to end of treatment (approximately 7-14 weeks) |
| Brief Inventory of Psychosocial Functioning (B-IPF) | A 7-item, self-report measures of psychosocial functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living. In each area on a 7-point scale ranging from 0 = Not at all to 6 = Very much. The B-IPF total score is calculated by summing the scale items completed by the respondent, dividing by the maximum possible score based upon the number of applicable items and multiplying by 100. Higher scores indicate greater psychosocial dysfunction. | Baseline to 1 month post treatment (approximately 11-18 weeks) |
| Dimensions of Anger Reactions (DAR-5) | A 5-item self report measure that assesses anger frequency, intensity, urge to act aggressively and impact on social functioning over the past 1 month. Respondents are asked how impacted they have been on a five-point Likert scale ranging from 0-5. Items are summed to provide a total severity score (range 5-25). A score of 12 or higher indicates problematic anger. | Baseline to 1 month post treatment (approximately 11-18 weeks) |
| Revised Conflict Tactics Scale Short Form (CTS-2) | The CTS-2 poses 39 questions to assess five tactics used when conflict occurs within the relationships of dating, cohabitating, or marital couples. For this study, only the Physical Assault and Psychological Aggression subscales (20 items) of the CTS-2 will be used, broadening the assessment of conflict to query interpersonal conflict among friends, colleagues, and acquaintances as well as the family. The scoring range is: 0-6, Two Subscales: 1) Psychological Aggression: 1-8 2) Physical Assault: 9-20, Special Coding: Sum midpoints of chosen response option: Never-0, Once-1, Twice-2, 3-5 times -4 , 6-10 times-8, 11-20 times-15, greater than 20 times-25. For item scoring range 0-25, Psychological Aggression scoring range 0-200, Physical Assault scoring range 0-300. The higher scores indicate higher levels of Psychological Aggression and Physical Assault. | Baseline to 1 month post treatment (approximately 11-18 weeks) |
| Trauma-Related Anger Scale (TRAS) | A 19-item self report measure to assess anger in the context of posttraumatic stress. Participants are asked to rate each item from Not at all true (0) to ;Definitely True(3) both prior to their traumatic event, and within the past two weeks. The scoring range for the items summed to provide a total severity score is 0-57. Items 1-7 = Anger giving a sense of control or energy, Items 8-14 = thought and emotional avoidance relating to anger, Items 15-17 = anger in response to threat, Items 18-19 = anger in response to pity. The higher score means greater anger in the context of PTSD. Higher scores in past two weeks, as compared with pre-trauma scores, indicate more severe trauma-related anger. | Baseline to 1 month post treatment (approximately 11-18 weeks) |