Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans (TOTRA)
20 octobre 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
112
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Rhode Island
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Providence, Rhode Island, États-Unis, 02908
- Providence VA Medical Center, Providence, RI
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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.
|
Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment
|
|
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
Délai: 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.
|
Baseline, Weeks 4, 8,12 (end of treatment), 3 and 6 months post-treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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
|
|
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
Délai: 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
|
|
Least Squares Mean Total Score on the Outcomes Questionnaire (OQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
Délai: 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
|
|
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
Délai: 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.
|
Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment
|
|
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
Délai: 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.
|
Baseline,12 weeks (end of treatment), 3 and 6 months post-treatment
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Least Squares Mean Total Score on the Anger Consequences Questionnaire (ACQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Tracie M. Shea, PhD, Providence VA Medical Center, Providence, RI
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 janvier 2015
Achèvement primaire (Réel)
28 février 2019
Achèvement de l'étude (Réel)
28 février 2019
Dates d'inscription aux études
Première soumission
6 mai 2014
Première soumission répondant aux critères de contrôle qualité
3 juin 2014
Première publication (Estimation)
6 juin 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 novembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 octobre 2021
Dernière vérification
1 octobre 2021
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- D1146-R
- Rx 001146 (Autre subvention/numéro de financement: VA RR&D)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Oui
Description du régime IPD
I anticipate sharing the data, but have not yet developed a specific plan.
Délai de partage IPD
April 1 2021
Type d'informations de prise en charge du partage d'IPD
- Protocole d'étude
- Plan d'analyse statistique (PAS)
- Rapport d'étude clinique (CSR)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .