- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02157779
Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans (TOTRA)
20 de octubre de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
112
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Rhode Island
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Providence, Rhode Island, Estados Unidos, 02908
- Providence VA Medical Center, Providence, RI
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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
Otros nombres:
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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
Periodo de tiempo: 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
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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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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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
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Least Squares Mean Total Score on the Anger Consequences Questionnaire (ACQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Tracie M. Shea, PhD, Providence VA Medical Center, Providence, RI
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2015
Finalización primaria (Actual)
28 de febrero de 2019
Finalización del estudio (Actual)
28 de febrero de 2019
Fechas de registro del estudio
Enviado por primera vez
6 de mayo de 2014
Primero enviado que cumplió con los criterios de control de calidad
3 de junio de 2014
Publicado por primera vez (Estimar)
6 de junio de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de noviembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
20 de octubre de 2021
Última verificación
1 de octubre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- D1146-R
- Rx 001146 (Otro número de subvención/financiamiento: VA RR&D)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
I anticipate sharing the data, but have not yet developed a specific plan.
Marco de tiempo para compartir IPD
April 1 2021
Tipo de información de apoyo para compartir IPD
- Protocolo de estudio
- Plan de Análisis Estadístico (SAP)
- Informe de estudio clínico (CSR)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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