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Trial record 6 of 24 for:    Recruiting, Not yet recruiting, Available Studies | "Bereavement"

Treatment of Prolonged Grief Disorder in Combat Veterans (PGD)

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ClinicalTrials.gov Identifier: NCT02283333
Recruitment Status : Recruiting
First Posted : November 5, 2014
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

The purpose of this study is to compare the efficacy of an experimental treatment (termed BATE-G) for Prolonged Grief Disorder (PGD) in Veterans compared to the current, VA-approved standard of care treatment. Currently, treatments for grief in Veterans remain understudied. Our research group has recently completed pilot work on an innovative, technology-leveraged treatment protocol for PGD that combines Behavioral Activation with Therapeutic Exposure (BATE) and appears readily applicable to the Veteran and Military populations. Per the VA / DoD Iraq War Clinician Guide, 2nd ed., the current standard of treatment is Cognitive Restructuring and Supportive Grief Counseling.

The study will enroll 140 Veterans, aged 21 years and older, who served in any combat era. All Veterans will meet criteria for PGD. There will be assessments at baseline, 1 week, 3 months, and 6 months post treatment. During the treatment phase, Veterans will undergo 7 weekly sessions of either BATE-G or standard treatment. Sessions 2-6 will be delivered via televideo to the Veteran's home.

We hypothesize that BATE-G will be more effective than standard treatment in reducing symptoms of PGD, both at post-treatment and follow-up. Moreover, BATE-G will be more effective in reducing acute emotional distress and preventing long-term emotional distress in terms of general depression and anxiety symptoms. BATE-G will result in increased frequency of completed positively reinforcing, community-based events when compared to Cognitive Restructuring and Supportive Grief Counseling. BATE-G will also result in greater improvements in perceived social support and health.

Note: This project is the first evidence-based treatment for PGD in military populations, thus addressing a significant service gap.


Condition or disease Intervention/treatment Phase
Prolonged Grief Disorder Behavioral: BATE-G Behavioral: Standard Treatment Not Applicable

Detailed Description:
The 'dual burden' of (a) loss of a fellow service member in the context of (b) experiencing repeated extreme life threat is unique to military combat personnel and a core characteristic of combat-related Prolonged Grief Disorder (PGD), a disorder as prevalent as Post-traumatic stress disorder and associated with functional impairment, disability, and suicidality. Effective treatments for depression and PTSD have proven less than adequate in treating PGD when each is offered in isolation; and simply combining these 12-16 week treatment regimens into a 24-36 week treatments is not a viable approach, particularly with a population predisposed to avoiding extended mental health care. This project addresses the need for a Veteran/ military specific treatment of PGD, and uses technology to deliver this treatment in a format that is far more likely to be accepted by military personnel and Veterans. This study will impact clinical practice by providing the first evidence for effective treatment of PGD in Veterans.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Prolonged Grief Disorder in Combat Veterans
Actual Study Start Date : December 1, 2014
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bereavement

Arm Intervention/treatment
Experimental: BATE-G
Behavioral Activation and Therapeutic Exposure - Grief therapy are delivered in 7 weekly sessions to the participant.
Behavioral: BATE-G
Behavioral Activation and Therapeutic Exposure - Grief therapy are delivered in 7 weekly sessions to the participant.

Active Comparator: Standard Treatment
Cognitive Restructuring and Supportive Grief Counseling are delivered in 7 weekly sessions to the participant.
Behavioral: Standard Treatment
Cognitive Restructuring and Supportive Grief Counseling are delivered in 7 weekly sessions to the participant.




Primary Outcome Measures :
  1. Inventory of Complicated Grief - Revised (ICG-R) [ Time Frame: Baseline ]
    The Inventory of Complicated Grief (ICG) is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. It has 17 items, with a cut off score of 25 permitting diagnosis.

  2. Inventory of Complicated Grief - Revised (ICG-R) [ Time Frame: 8 weeks ]
    The Inventory of Complicated Grief (ICG) is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. It has 17 items, with a cut off score of 25 permitting diagnosis.

  3. Inventory of Complicated Grief - Revised (ICG-R) [ Time Frame: 3 months ]
    The Inventory of Complicated Grief (ICG) is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. It has 17 items, with a cut off score of 25 permitting diagnosis.

  4. Inventory of Complicated Grief - Revised (ICG-R) [ Time Frame: 6 months ]
    The Inventory of Complicated Grief (ICG) is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. It has 17 items, with a cut off score of 25 permitting diagnosis.


Secondary Outcome Measures :
  1. Mini International Neuropsychiatric Interview (M.I.N.I.) [ Time Frame: Baseline ]
    The MINI is a brief structured interview that assesses the criteria for DSM-IV Axis I diagnoses. The MINI will be used to assess for a diagnosis of current depression, panic symptoms, generalized anxiety symptoms and to screen for substance dependence.

  2. Beck Depression Inventory - II (BDI-II) [ Time Frame: Baseline ]
    Beck Depression Inventory-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.

  3. Beck Anxiety Inventory (BAI) [ Time Frame: Baseline ]
    This is a 21 item self-report measure that assesses anxiety levels.

  4. Health Related Functioning: Medical Outcome Study Short Form - 36 (SF 36) [ Time Frame: Baseline ]
    This is a self report scale that measures health status and functioning over the past four weeks.

  5. PTSD Checklist for DSM-5 (PCL 5) [ Time Frame: Baseline ]
    The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including: monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis.

  6. Index of Functional Impairment (IFI) [ Time Frame: Baseline ]
    The Index of Functional Impairment (IFI) is a self-report inventory of functional impairment. Patients rate their level of functioning across multiple psychosocial domains including romantic relationships, employment, and educational achievement.

  7. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline ]
    The PSQI is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with rating of 5 or higher indicative of poor sleep quality.

  8. Mini International Neuropsychiatric Interview (M.I.N.I.) [ Time Frame: 8 weeks ]
    The MINI is a brief structured interview that assesses the criteria for DSM-IV Axis I diagnoses. The MINI will be used to assess for a diagnosis of current depression, panic symptoms, generalized anxiety symptoms and to screen for substance dependence.

  9. The Medical Outcomes Study (MOS) Social Support Survey Form [ Time Frame: Baseline ]
    This is a 19 item assessment that covers four domains: emotional/informational support, tangible support, positive social interaction, and affection.

  10. Mini International Neuropsychiatric Interview (M.I.N.I.) [ Time Frame: 6 months ]
    The MINI is a brief structured interview that assesses the criteria for DSM-IV Axis I diagnoses. The MINI will be used to assess for a diagnosis of current depression, panic symptoms, generalized anxiety symptoms and to screen for substance dependence.

  11. Service Delivery Perceptions Questionnaire [ Time Frame: 8 weeks ]
    This questionnaire is used to assess subjects' perceptions about variables specifically related to the mode of service delivery (quality of communication, ease of use, willingness to use treatment, etc.)

  12. Treatment Credibility Questionnaire [ Time Frame: 8 weeks ]
    This questionnaire is used to assess for differences in outcome expectancy using treatment credibility scales.

  13. Beck Depression Inventory - II (BDI-II) [ Time Frame: 8 weeks ]
    Beck Depression Inventory-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.

  14. Beck Depression Inventory - II (BDI-II) [ Time Frame: 3 months ]
    Beck Depression Inventory-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.

  15. Beck Depression Inventory - II (BDI-II) [ Time Frame: 6 months ]
    Beck Depression Inventory-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.

  16. Beck Anxiety Inventory (BAI) [ Time Frame: 8 weeks ]
    This is a 21 item self-report measure that assesses anxiety levels.

  17. Beck Anxiety Inventory (BAI) [ Time Frame: 3 months ]
    This is a 21 item self-report measure that assesses anxiety levels.

  18. Beck Anxiety Inventory (BAI) [ Time Frame: 6 months ]
    This is a 21 item self-report measure that assesses anxiety levels.

  19. Health Related Functioning: Medical Outcome Study Short Form - 36 (SF 36) [ Time Frame: 8 weeks ]
    This is a self report scale that measures health status and functioning over the past four weeks.

  20. Health Related Functioning: Medical Outcome Study Short Form - 36 (SF 36) [ Time Frame: 3 months ]
    This is a self report scale that measures health status and functioning over the past four weeks.

  21. Health Related Functioning: Medical Outcome Study Short Form - 36 (SF 36) [ Time Frame: 6 months ]
    This is a self report scale that measures health status and functioning over the past four weeks.

  22. PTSD Checklist for DSM-5 (PCL 5) [ Time Frame: 8 weeks ]
    The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including: monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis.

  23. PTSD Checklist for DSM-5 (PCL 5) [ Time Frame: 3 months ]
    The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including: monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis.

  24. PTSD Checklist for DSM-5 (PCL 5) [ Time Frame: 6 months ]
    The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including: monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis.

  25. Index of Functional Impairment (IFI) [ Time Frame: 8 weeks ]
    The Index of Functional Impairment (IFI) is a self-report inventory of functional impairment. Patients rate their level of functioning across multiple psychosocial domains including romantic relationships, employment, and educational achievement.

  26. Index of Functional Impairment (IFI) [ Time Frame: 3 months ]
    The Index of Functional Impairment (IFI) is a self-report inventory of functional impairment. Patients rate their level of functioning across multiple psychosocial domains including romantic relationships, employment, and educational achievement.

  27. Index of Functional Impairment (IFI) [ Time Frame: 6 months ]
    The Index of Functional Impairment (IFI) is a self-report inventory of functional impairment. Patients rate their level of functioning across multiple psychosocial domains including romantic relationships, employment, and educational achievement.

  28. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 weeks ]
    The PSQI is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with rating of 5 or higher indicative of poor sleep quality.

  29. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 3 months ]
    The PSQI is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with rating of 5 or higher indicative of poor sleep quality.

  30. Pleasant Activities List (PAL) [ Time Frame: Baseline ]
    The Pleasant Activities List (PAL) is a 139-itme behavioral questionnaire that assesses the frequency and enjoyability of pleasant activities occurring in the natural environment. Although originally researched with patients who had substance use disorders, the PAL is a standardized, feasible, and valid instrument to sample non-substance-related rewarding activities in patients' everyday lives.

  31. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 6 months ]
    The PSQI is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with rating of 5 or higher indicative of poor sleep quality.

  32. Pleasant Activities List (PAL) [ Time Frame: 8 weeks ]
    The Pleasant Activities List (PAL) is a 139-itme behavioral questionnaire that assesses the frequency and enjoyability of pleasant activities occurring in the natural environment. Although originally researched with patients who had substance use disorders, the PAL is a standardized, feasible, and valid instrument to sample non-substance-related rewarding activities in patients' everyday lives.v

  33. The Medical Outcomes Study (MOS) Social Support Survey Form [ Time Frame: 8 weeks ]
    This is a 19 item assessment that covers four domains: emotional/informational support, tangible support, positive social interaction, and affection.

  34. Pleasant Activities List (PAL) [ Time Frame: 3 months ]
    The Pleasant Activities List (PAL) is a 139-itme behavioral questionnaire that assesses the frequency and enjoyability of pleasant activities occurring in the natural environment. Although originally researched with patients who had substance use disorders, the PAL is a standardized, feasible, and valid instrument to sample non-substance-related rewarding activities in patients' everyday lives.

  35. The Medical Outcomes Study (MOS) Social Support Survey Form [ Time Frame: 3 months ]
    This is a 19 item assessment that covers four domains: emotional/informational support, tangible support, positive social interaction, and affection.

  36. Pleasant Activities List (PAL) [ Time Frame: 6 months ]
    The Pleasant Activities List (PAL) is a 139-itme behavioral questionnaire that assesses the frequency and enjoyability of pleasant activities occurring in the natural environment. Although originally researched with patients who had substance use disorders, the PAL is a standardized, feasible, and valid instrument to sample non-substance-related rewarding activities in patients' everyday lives.

  37. The Medical Outcomes Study (MOS) Social Support Survey Form [ Time Frame: 6 months ]
    This is a 19 item assessment that covers four domains: emotional/informational support, tangible support, positive social interaction, and affection.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants may be either Active Duty Service Personnel/Veterans of any service era.
  • Participants may be male or female,

    • age 21 and above,
    • with a diagnosis of Prolonged Grief Disorder.
  • Veterans starting a new psychotropic medication at baseline will be asked to wait 4 weeks for medication stabilization before starting the study.

Exclusion Criteria:

  • Actively psychotic or demented persons,
  • Individuals with both suicidal ideation and clear intent,
  • Individuals with homicidal ideation and or intent,
  • Individuals meeting criteria for substance dependence,
  • Individuals who cannot or are unwilling to schedule regular weekly appointments (with the exception of Veterans who have medical and/or transportation barriers,
  • Individuals who are already enrolled in another trial for PTSD and/or depression will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283333


Contacts
Contact: Ron E Acierno, PhD MS BA (843) 789-7246 Ron.Acierno@va.gov
Contact: Peter W Tuerk, PhD MA BA (843) 789-6188 ext 6188 Peter.Tuerk@va.gov

Locations
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC Recruiting
Charleston, South Carolina, United States, 29401-5799
Contact: Stephanie M Zeigler       Stephanie.Zeigler@va.gov   
Principal Investigator: Ron E. Acierno, PhD MS BA         
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29401
Contact: Stephanie M Zeigler, MPH    843-789-6519    zeigls@musc.edu   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Ron E. Acierno, PhD MS BA Ralph H. Johnson VA Medical Center, Charleston, SC

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02283333     History of Changes
Other Study ID Numbers: CLNA-001-14S
CX001102 ( Other Grant/Funding Number: VA CSR&D )
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Behavioral Activation
Therapeutic Exposure
Mental Health
Veterans
Complicated Grief
Military
Treatment
Cognitive Therapy
Bereavement
Complicated Bereavement

Additional relevant MeSH terms:
Disease
Pathologic Processes