Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013091
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Treatment of Depression in Patients With PTSD
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Treatment of Depression in Patients With PTSD
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Post-traumatic stress disorder is a mental health problem of enormous proportion within the VA system for both male and female veterans The 40 percent of veterans with PTSD and concurrent clinically significant depression are particularly difficult to treat Effective and efficient treatment of veterans with this combination of disorders would be of benefit to a significant number of veterans
Detailed Description:
Background
Post-traumatic stress disorder is a mental health problem of enormous proportion within the VA system for both male and female veterans The 40 percent of veterans with PTSD and concurrent clinically significant depression are particularly difficult to treat Effective and efficient treatment of veterans with this combination of disorders would be of benefit to a significant number of veterans
Objectives
Well-validated treatments of PTSD and its complications are rare There are no studies of treatment addressing the sequelae of chronic PTSD including depressive symptomatology Our study is the first randomized controlled study of group psychosocial interventions for the combination of PTSD and depression in male and female veterans The purpose of the study is to evaluate the impact of two psychosocial interventions on clinical outcomes and on the use of hospital resources by veterans with these co-existing disorders
Methods
Male and female veterans with both PTSD and depressive diagnoses will be recruited for the study Male veterans must have combat-related PTSD and female veterans will have trauma related to sexual assault Veterans will be randomly assigned to either Self-Management Therapy Rehm 1984 a cognitive-behavioral treatment program for depression or to a Psychoeducational Group Therapy Dunn et al 1998 Both programs involve short-term group therapies that teach veterans about their disorders and provide them with new strategies and skills for overcoming them These therapy groups will be in addition to other standard care that veterans receive within the Trauma Recovery Program at the Houston VA Medical Center Approximately 120 male veterans and 60 female veterans will be enrolled in the program Participants will be assessed at pretest posttest and at 3- 6- and 12-month follow-up periods utilizing various clinician-administered and self-report instruments of psychiatric symptomatology psychosocial functioning constructs targeted by the therapy groups treatment compliances and satisfaction
Status
Final report preparation
Post-traumatic stress disorder is a mental health problem of enormous proportion within the VA system for both male and female veterans The 40 percent of veterans with PTSD and concurrent clinically significant depression are particularly difficult to treat Effective and efficient treatment of veterans with this combination of disorders would be of benefit to a significant number of veterans
Objectives
Well-validated treatments of PTSD and its complications are rare There are no studies of treatment addressing the sequelae of chronic PTSD including depressive symptomatology Our study is the first randomized controlled study of group psychosocial interventions for the combination of PTSD and depression in male and female veterans The purpose of the study is to evaluate the impact of two psychosocial interventions on clinical outcomes and on the use of hospital resources by veterans with these co-existing disorders
Methods
Male and female veterans with both PTSD and depressive diagnoses will be recruited for the study Male veterans must have combat-related PTSD and female veterans will have trauma related to sexual assault Veterans will be randomly assigned to either Self-Management Therapy Rehm 1984 a cognitive-behavioral treatment program for depression or to a Psychoeducational Group Therapy Dunn et al 1998 Both programs involve short-term group therapies that teach veterans about their disorders and provide them with new strategies and skills for overcoming them These therapy groups will be in addition to other standard care that veterans receive within the Trauma Recovery Program at the Houston VA Medical Center Approximately 120 male veterans and 60 female veterans will be enrolled in the program Participants will be assessed at pretest posttest and at 3- 6- and 12-month follow-up periods utilizing various clinician-administered and self-report instruments of psychiatric symptomatology psychosocial functioning constructs targeted by the therapy groups treatment compliances and satisfaction
Status
Final report preparation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None