Treatment of Chronic Anger and Aggression Following Military-Related Betrayal

Официальное название

Assessment and Treatment of Chronic Anger and Aggression Following Military-Related Interpersonal and Institutional Betrayal: A Pilot Investigation

Обзор

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: * Will participants be satisfied with the treatment, and is the treatment feasible to do in a military outpatient setting * Will the treatment help with anger and aggression issues. 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.

Подробное описание

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:

* Complete a 5-10 minute assessment twice per week (Monday/Thursday or Tuesday/Friday) to assess level of anger, aggression, and interactions with others since last assessment. * The assigned therapist will call participants once a week for a 10-minute, check-in. * At the end of participants' assigned wait time, they will complete an assessment of level of anger, aggression, interactions with others, mental, and physical health. * During treatment:

* Begin treatment within 1 week of last wait time assessment. * Participate in 7-24 (average 14) one-hour bi-weekly (Monday/Thursday or Tuesday/Friday) CART sessions. * Prior to each session, participants will complete the same 5-10 minute assessment to assess level of anger, aggression, and interactions with others since last assessment. * At the final treatment session, participants will be scheduled to complete a 1-month follow-up assessment. * For follow-up:

* Complete a 1-month follow up assessment between 4-8 weeks after the final treatment session. * Participants will be sent a link to complete the follow-up assessment. * Complete the same questionnaires completed at pre-treatment plus an exit interview and a brief satisfaction survey.

Вмешательства

• Поведенческое Countering Chronic Anger and Aggression Related to Trauma and Transgressions (CART)
  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.

Первичные конечные точки

• Successful recruitment [Срок оценки: Study start to last subject enrolled, approximately 1 year]
• Client satisfaction survey (CSQ-8) [Срок оценки: 1 month after study end ( at approximately 11-18 weeks)]
• Overt Aggression Scale-Modified (OAS-M) [Срок оценки: Baseline to 1 month post treatment (approximately 11-18 weeks)]
• Inventory of Interpersonal Problems-Short Version (IIP-32) [Срок оценки: Baseline to 1 month post treatment (approximately 11-18 weeks)]
• State Trait Anger Expression Inventory-2 (STAXI-2) [Срок оценки: Baseline to 1 month post treatment (approximately 11-18 weeks)]

Вторичные конечные точки (6)

• Rate of protocol completion [Срок оценки: Treatment end (Approximately 7-14 weeks)]
• Number of modules completed [Срок оценки: Baseline to end of treatment (approximately 7-14 weeks)]
• Brief Inventory of Psychosocial Functioning (B-IPF) [Срок оценки: Baseline to 1 month post treatment (approximately 11-18 weeks)]
• Dimensions of Anger Reactions (DAR-5) [Срок оценки: Baseline to 1 month post treatment (approximately 11-18 weeks)]
• Revised Conflict Tactics Scale Short Form (CTS-2) [Срок оценки: Baseline to 1 month post treatment (approximately 11-18 weeks)]
• Trauma-Related Anger Scale (TRAS) [Срок оценки: Baseline to 1 month post treatment (approximately 11-18 weeks)]

Критерии участия

Критерии включения

• Adult active duty military service members and veterans aged 18 or older.
• Endorses a history of military-related betrayal (on the Modified Moral Injury Questionnaire)
• Endorses problematic anger in the past month (as evidenced by a score of 12 or above on the Dimensions of Anger Reactions; DAR-5)
• Engaged in at least 1 self-reported act of aggression in the past 1 month (on the Overt Aggression Scale-Modified; OAS-M)

Критерии исключения

• Participated in an anger management or trauma-focused intervention within the past 3 months as assessed by self-report.
• Acute suicidality requiring immediate intervention, such as hospitalization as assessed by the Depressive Symptoms Index-Suicidality Subscale (DSI-SS) combined with follow up clinical interview for elevated scores.
• Is currently homicidal with plans and intent to hurt a specific person and requiring immediate intervention as measured by self-report and follow-up with clinician if screened positive.
• Moderate to severe brain injury as measured by inability to comprehend the informed consent document or baseline assessments.
• Has severe alcohol consumption patterns as evidenced by a score of 19 or above on the Alcohol Use Disorders Identification Test (AUDIT).
• Experiencing active psychosis or mania as measured by the Prodromal Questionnaire-Brief Version and the Mood Disorders Questionnaire.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Carl R. Darnall Army Medical Center (CRDAMC) at Fort Cavazos — Fort Cavazos

Идентификаторы

NCT: NCT06609330 · 20230329HU · W81XWH-22-2-0085

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗