Randomizovaná klinická studie MARI (MARI)
Randomizovaná kontrolovaná zkouška mobilní intervence pro snížení vzteku pro veterány
Difficulty controlling anger is the most commonly reported reintegration concern among combat Veterans, especially those with a diagnosis of posttraumatic stress disorder (PTSD). Problematic anger is associated with significant functional impairment. In the current project, the investigators will compare the Mobile Anger Reduction Intervention (MARI) with a health education mobile intervention (HED) among Veterans with PTSD and problematic anger. Participants will be randomized to the MARI or HED condition. The hypothesis is that participants in the MARI condition will experience greater anger reductions and functional improvements relative to the HED condition.
Přehled studie
Postavení
Podmínky
Detailní popis
Difficulty controlling anger is the most commonly reported reintegration concern among combat Veterans, especially those with a diagnosis of posttraumatic stress disorder (PTSD). In Veterans, problematic anger is associated with numerous negative psychosocial outcomes, including poor functional outcomes (both social and occupational), family discord, aggression, road rage, and suicide risk. Anger can also impede successful outcomes from PTSD treatment. Given the high prevalence of anger problems among Veterans with PTSD and the associated functional impairments, there is a clear need to develop innovative and effective anger interventions to improve functional outcomes. Use of mobile health (mHealth) technology could provide a low-cost method to increase the reach of anger management treatments to this high-need group of Veterans.
One of the mechanisms associated with problematic anger and aggression is hostile interpretation bias, i.e., a tendency to interpret ambiguous interpersonal situations as hostile. By reducing hostile interpretation bias, the investigators can reduce problematic anger and aggression and improve functional outcomes. A mobile application that uses evidence-based interpretation bias modification techniques to reduce hostile interpretation bias and anger outcomes has been developed and piloted. The goal of this project is to evaluate the efficacy of this mobile application among Veterans with PTSD.
A randomized controlled trial (RCT) will be conducted, in which 150 Veterans with PTSD and problematic anger will be randomized to either the Mobile Anger Reduction Intervention (MARI) or a health education condition (HED). The central hypothesis is that participants in the MARI condition will experience greater anger reductions and functional improvements relative to the HED condition.
The proposed research project will address the following Specific Aims: Aim 1: To evaluate the efficacy of MARI on anger outcomes (e.g., hostile interpretation bias, problematic anger) measured at post-treatment, 3-months, and 6-months post treatment; Aim 2: To evaluate the efficacy of MARI on functional improvements (i.e., psychosocial functioning, quality of life) and self-harm measured at post-treatment, 3-months, and 6-months post treatment; and Exploratory Aim: To explore whether changes in hostile interpretation bias (proposed treatment mechanism) mediate functional improvements.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Kirsten H Dillon, PhD
- Telefonní číslo: (919) 286-0411
- E-mail: Kirsten.Dillon@va.gov
Studijní záloha kontaktů
- Jméno: Angela C Kirby, MS
- Telefonní číslo: 7456 (919) 286-0411
- E-mail: angela.kirby@va.gov
Studijní místa
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North Carolina
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Durham, North Carolina, Spojené státy, 27705-3875
- Nábor
- Durham VA Medical Center, Durham, NC
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Kontakt:
- Kirsten H Dillon, PhD
- Telefonní číslo: (919) 286-0411
- E-mail: Kirsten.Dillon@va.gov
-
Vrchní vyšetřovatel:
- Kirsten H Dillon, PhD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Veterans diagnosed with Post-traumatic stress disorder (PTSD), established via chart review and a score of greater than or equal to 33 on the PTSD Checklist for DSM-5 (PCL-5)
- Reporting a score of greater than or equal to 12 on the 5-item Dimensions of Anger Reactions Scale
- Have not had any changes to type or dose of psychiatric medications for 3 months, with no plans to make adjustments in the next 6 months
- Able to read at least 6th grade level material
Exclusion Criteria:
- Currently in a period of active psychosis or mania
- Exhibit current prominent suicidal or homicidal ideation requiring immediate intervention
- Have used the Mobile Anger Reduction Intervention (MARI) application before as part of another research study
- Receiving (or plan to receive) other anger management psychotherapy or trauma-focused therapy for PTSD (i.e., prolonged exposure, cognitive processing therapy during the course of the study
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Mobile Anger Reduction Intervention (MARI)
Participants in this arm will download the MARI application (app) on their own smart phone device and will use the app for a period of 4 weeks. |
This is a mobile intervention that uses interpretation bias modification (IBM) techniques to reduce the hostile interpretation bias. Participants will download the MARI app and be instructed to complete at least 5 treatment sessions each week for a period of 4 weeks. Each session takes approximately 10 minutes. The app also includes a Nightly Diary to track symptoms, a calendar to program session reminders, and a My Progress feature to track use and performance. |
|
Aktivní komparátor: Health Education Condition (HED)
Participants in this arm will download the HED application (app) on their own smart phone device and will use the app for a period of 4 weeks. |
This is a mobile application that delivers videos with psychoeducation about healthy habits and selfcare for general wellness. Participants will download the HED app and be instructed to use it at least 5 times a week for a period of 4 weeks. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
number of participants below the clinical cut off for problematic anger
Časové okno: Post-treatment (approx. one month after baseline assessment)
|
Measured with the Dimensions of Anger Reactions-5 scale; scores range from 5-25, with higher scores indicating higher levels of problematic anger; the clinical cut off is 12. The investigators will count the number of participants in each group who have a score lower than 12. |
Post-treatment (approx. one month after baseline assessment)
|
|
number of participants below the clinical cut off for problematic anger
Časové okno: 6-month follow-up
|
Measured with the Dimensions of Anger Reactions-5 scale; scores range from 5-25, with higher scores indicating higher levels of problematic anger; the clinical cut off is 12. The investigators will count the number of participants in each group who have a score lower than 12. |
6-month follow-up
|
|
number of participants below the clinical cut off for problematic anger
Časové okno: 3-month follow-up
|
Measured with the Dimensions of Anger Reactions-5 scale; scores range from 5-25, with higher scores indicating higher levels of problematic anger; the clinical cut off is 12. The investigators will count the number of participants in each group who have a score lower than 12. |
3-month follow-up
|
|
number of participants with decreased hostile interpretation bias scores
Časové okno: from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
Measured with the Word Sentence Association Paradigm-Hostility, hostility subscale. Scores range from 1-6, with higher scores indicating higher levels hostile interpretation bias. The investigators will count the number of participants in each group who have a reduction in scores within the time frame. |
from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
|
number of participants with decreased hostile interpretation bias scores
Časové okno: from baseline to 3-month follow-up
|
Measured with the Word Sentence Association Paradigm-Hostility, hostility subscale. Scores range from 1-6, with higher scores indicating higher levels hostile interpretation bias. The investigators will count the number of participants in each group who have a reduction in scores within the time frame. |
from baseline to 3-month follow-up
|
|
number of participants with decreased hostile interpretation bias scores
Časové okno: from baseline to 6-month follow-up
|
Measured with the Word Sentence Association Paradigm-Hostility, hostility subscale. Scores range from 1-6, with higher scores indicating higher levels hostile interpretation bias. The investigators will count the number of participants in each group who have a reduction in scores within the time frame. |
from baseline to 6-month follow-up
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
number of participants with decreased psychosocial impairment scores
Časové okno: from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
Measured with the Brief Inventory of Psychosocial Functioning. Scores range from 0-6, with higher scores indicating higher levels of psychosocial impairment. The investigators will count the number of participants in each group who have a reduction of scores within the time frame. |
from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
|
number of participants with decreased psychosocial impairment scores
Časové okno: from baseline to 3-month follow-up
|
Measured with the Brief Inventory of Psychosocial Functioning. Scores range from 0-6, with higher scores indicating higher levels of psychosocial impairment. The investigators will count the number of participants in each group who have a reduction of scores within the time frame. |
from baseline to 3-month follow-up
|
|
number of participants with decreased psychosocial impairment scores
Časové okno: from baseline to 6-month follow-up
|
Measured with the Brief Inventory of Psychosocial Functioning. Scores range from 0-6, with higher scores indicating higher levels of psychosocial impairment. The investigators will count the number of participants in each group who have a reduction of scores within the time frame. |
from baseline to 6-month follow-up
|
|
number of participants with improved quality of life
Časové okno: from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
Measured with the Quality of Life Inventory. Scores range from -6-6, with higher scores indicating higher levels of satisfaction with life. The investigators will count the number of participants in each group who have an increase in their score within the time frame. |
from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
|
number of participants with improved quality of life
Časové okno: from baseline to 3-month follow-up
|
Measured with the Quality of Life Inventory. Scores range from -6-6, with higher scores indicating higher levels of satisfaction with life. The investigators will count the number of participants in each group who have an increase in their score within the time frame. |
from baseline to 3-month follow-up
|
|
number of participants with improved quality of life
Časové okno: from baseline to 6-month follow-up
|
Measured with the Quality of Life Inventory. Scores range from -6-6, with higher scores indicating higher levels of satisfaction with life. The investigators will count the number of participants in each group who have an increase in their score within the time frame. |
from baseline to 6-month follow-up
|
|
number of participants with reduced suicidal ideation
Časové okno: from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
Measured with the Columbia- Suicide Severity Rating Scale, suicidal ideation intensity rating. Scores range from 0-25, with higher scores indicating higher intensity of suicidal ideation. The investigators will count the number of participants in each group who have a decrease in their score within the time frame. |
from baseline to post-treatment assessments (approx. one month after baseline assessment)
|
|
number of participants with reduced suicidal ideation
Časové okno: from baseline to 3-month follow-up
|
Measured with the Columbia- Suicide Severity Rating Scale, suicidal ideation intensity rating. Scores range from 0-25, with higher scores indicating higher intensity of suicidal ideation. The investigators will count the number of participants in each group who have a decrease in their score within the time frame. |
from baseline to 3-month follow-up
|
|
number of participants with reduced suicidal ideation
Časové okno: from baseline to 6-month follow-up
|
Measured with the Columbia- Suicide Severity Rating Scale, suicidal ideation intensity rating. Scores range from 0-25, with higher scores indicating higher intensity of suicidal ideation. The investigators will count the number of participants in each group who have a decrease in their score within the time frame. |
from baseline to 6-month follow-up
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Kirsten H Dillon, PhD, Durham VA Medical Center, Durham, NC
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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