- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02157779
Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans (TOTRA)
20. října 2021 aktualizováno: VA Office of Research and Development
Excessive and poorly controlled anger is one of the most common problems experienced by war Veterans.
The consequences can be severe, including increased risk for divorce, domestic violence, job loss and instability, and other serious impairments in family, social, and occupational functioning.
Availability of effective treatments is critical to reducing the adverse effects of anger in Veterans.
The investigators propose to conduct a controlled study to determine whether a cognitive behavior treatment that has been adapted for treating anger problems in Veterans of Iraq and Afghanistan results in improved outcomes compared to a supportive therapy.
Results will be examined for improvement in anger, functioning, and quality of life at end of 12 weekly sessions, and at 3 and 6 months following treatment.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
Poorly controlled anger is a common problem with often devastating effects in Veterans who have served in a warzone.
Adverse consequences include increased risk for divorce, domestic violence, job loss and instability, and other serious impairments in family, social, and occupational functioning.
Recent evidence indicates that anger and aggression are likely to be problems for a significant proportion of Veterans of Iraq (Operation Iraqi Freedom, OIF; Operation New Dawn, OND) and Afghanistan (Operation Enduring Freedom, OEF).
A survey of reintegration problems among 754 OEF/OIF combat Veterans receiving VA Medical care showed that anger was the most commonly reported problem, with 57% reporting increased problems in controlling anger.
Despite encouraging evidence for efficacy of cognitive behavioral interventions in treating anger in civilian samples, much less is known about the efficacy of such treatments for anger problems in military personnel following exposure to war zone trauma.
Promising preliminary findings for individually based cognitive behavioral treatment have been reported, and there is evidence that a group anger management treatment delivered by teleconferencing is as effective as the same treatment delivered in person, but to date there is not a single adequately powered randomized trial designed to test the efficacy of an anger treatment compared to an active control condition in Veterans.
Building on findings from the investigators' randomized pilot study, the objective of the current proposal is to conduct a randomized clinical trial with sufficient statistical power to test the effectiveness of a manualized cognitive behavioral intervention (CBI) that has been adapted from an existing treatment (Anger Control Therapy; Novaco, 1994, 2001) for the treatment of anger problems in OEF/OIF/OND Veterans, compared to a manualized supportive therapy intervention (SI) control condition.
Ninety OEF/OIF/OND Veterans reporting significant problems with anger will be randomized to receive 12 individual sessions of one of the two study conditions.
Outcomes including measures of anger and aggression; interpersonal, social and occupational functioning; and quality of life will be assessed during and at the end of treatment and at 3 and 6 month follow-ups.
Exploratory analyses will examine 1) whether a diagnosis of PTSD impacts treatment effectiveness and 2) potential mediators of treatment outcome with CBI.
Typ studie
Intervenční
Zápis (Aktuální)
112
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Rhode Island
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Providence, Rhode Island, Spojené státy, 02908
- Providence VA Medical Center, Providence, RI
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Male or Female current or former member of the military (active duty, National Guard or Reserve) Deployed to Iraq or Afghanistan
- Experience trauma during deployment
- Clinically significant anger
- At least 2 additional symptoms of PTSD hyperarousal
- If on medication, no changes within prior 4 weeks
Exclusion Criteria:
- Current severe substance use disorder or prior severe substance use disorder not in remission for at least 3 months
- Current psychotic symptoms
- current Mania or Bipolar Disorder
- Current suicidal or homicidal ideation requiring hospitalization
- Any severe cognitive impairment or history of Organic Mental Disorder
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Cognitive Behavioral Intervention (CBI)
12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies
|
Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
Ostatní jména:
|
Aktivní komparátor: Supportive Intervention (SI)
12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support
|
Includes individual therapy sessions using supportive and problem-solving strategies.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Least Squares Mean Anger Expression Index Score on the State Trait Anger Inventory 2 (STAXI-2) Using a Repeated Measures ANCOVA Adjusted for Baseline and Time Effects
Časové okno: Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment
|
The STAXI-2 is a revision of Spielberger's State-Trait Anger Expression Inventory (STAXI), expanded from 44 to 57 items.
It is a self-report questionnaire consisting of six scales and an Anger Expression Index (AX).
Scales include State Anger, Trait Anger, Anger Expression-Out, Anger Expression-In, Anger Control-Out and Anger Expression-In.
The Anger Expression Index is an overall measure of the expression and control of anger based on responses to the two anger expression and the two anger control subscales.
Minimum and Maximum Values range from 0 to 96, higher scores mean more anger.
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Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment
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Least Squares Mean Aggression Scale Score on the Overt Aggression Scale-Modified (OAS-M) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
Časové okno: Baseline, Weeks 4, 8,12 (end of treatment), 3 and 6 months post-treatment
|
Structured Interview that assesses verbal and physical aggressive behaviors.
Minimum and Maximum Values range from 0 to no maximum, higher scores mean more anger.
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Baseline, Weeks 4, 8,12 (end of treatment), 3 and 6 months post-treatment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Least Squares Mean Global Social Adjustment Score on the Longitudinal Interval Follow-up Evaluation (LIFE) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
Časové okno: Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment
|
Psychosocial functioning scales from the clinician administered Longitudinal Interval Follow-up Evaluation (LIFE) provides assessment of functioning in areas of work (employment, household, or student), various aspects of interpersonal functioning, recreation and satisfaction.
The global social adjustment score is based upon a 5 point scale.
Ratings are based on the past month.
The psychosocial functioning ratings have been found to be of generally high reliability.
Minimum and Maximum Values range from 1 to 5, higher scores mean worse functioning.
|
Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment
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Least Squares Mean Global Work Functioning Score on the Longitudinal Interval Follow-up Evaluation (LIFE) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
Časové okno: Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment
|
Psychosocial functioning scales from the clinician administered Longitudinal Interval Follow-up Evaluation (LIFE) provides assessment of functioning in areas of work (employment, household, or student), various aspects of interpersonal functioning, recreation, satisfaction and global social adjustment.
Ratings are based on the past month.
The psychosocial functioning ratings have been found to be of generally high reliability.
Minimum and Maximum Values for the work functioning global score range from 1 to 5, higher scores mean worse functioning.
|
Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment
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Least Squares Mean Total Score on the Outcomes Questionnaire (OQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
Časové okno: Baseline, 12 weeks, 3 and 6 months post-treatment
|
The OQ is a self report measure that assesses functioning and includes three subscales: symptom distress, interpersonal relations, and social role functioning.
Concurrent validity has been demonstrated in relation to internal consistency and reliability.
Additionally, the OQ has been shown to be fairly stable in untreated individuals and sensitive to change in those individuals in treatment.
Minimum and Maximum Values range from 0 to 180, higher scores mean worse functioning.
|
Baseline, 12 weeks, 3 and 6 months post-treatment
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Least Squares Mean Psychological Domain Score on the WHO Quality of Life (WHOQOL) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
Časové okno: Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment
|
The World Health Organization Quality of Life (WHOQOL-BREF), is 26 item self-report measure used to assess quality of life in multiple domains (i.e., physical, psychological, social, and environment).
Psychometric properties suggest that the measure is valid and reliable across cultures and nations.
Ratings are made on a 5 point scale.
The psychological subscale, which consists of 6 items, was used in this study.
Minimum and Maximum Values for the psychological domain range from 6 to 30, higher scores mean better quality of life.
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Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment
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Least Squares Mean PTSD Severity Score on the Clinician-Administered PTSD Scale (CAPS) for DSM-5 Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
Časové okno: Baseline,12 weeks (end of treatment), 3 and 6 months post-treatment
|
The CAPS-5 (updated for DSM-5) is a clinician administered structured interview for the assessment of DSM-5 PTSD.
The CAPS has excellent reliability and validity and is widely used in PTSD treatment research.
Each one of the DSM-5 PTSD symptoms is rated on a 0-4 (low to high) scale to determine symptom severity.
The cutoff used to establish the presence of an individual symptom is a score of 2 or greater.
Overall PTSD severity is computed by summing the totals for all items.
Minimum and Maximum Values range from 0 to 80, higher scores mean higher levels of symptomatology.
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Baseline,12 weeks (end of treatment), 3 and 6 months post-treatment
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Least Squares Mean Total Score on the Anger Consequences Questionnaire (ACQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
Časové okno: Baseline, Week 12, 3 and 6 months Post-treatment
|
The ACQ is a brief self-report measure developed to assess the frequency of negative anger-related behavioral consequences.
Internal consistencies of .75 to .91 have been reported.
This scale includes items not covered by the other anger measures, including for example, trouble with the law, driving recklessly, getting into an accident, damaging relationships, etc.
There are 50 items; minimum and maximum Values range from 0 to 200.
Higher scores means more anger.
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Baseline, Week 12, 3 and 6 months Post-treatment
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Tracie M. Shea, PhD, Providence VA Medical Center, Providence, RI
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. ledna 2015
Primární dokončení (Aktuální)
28. února 2019
Dokončení studie (Aktuální)
28. února 2019
Termíny zápisu do studia
První předloženo
6. května 2014
První předloženo, které splnilo kritéria kontroly kvality
3. června 2014
První zveřejněno (Odhad)
6. června 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. listopadu 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. října 2021
Naposledy ověřeno
1. října 2021
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- D1146-R
- Rx 001146 (Jiné číslo grantu/financování: VA RR&D)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ano
Popis plánu IPD
I anticipate sharing the data, but have not yet developed a specific plan.
Časový rámec sdílení IPD
April 1 2021
Typ podpůrných informací pro sdílení IPD
- Protokol studie
- Plán statistické analýzy (SAP)
- Zpráva o klinické studii (CSR)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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