Treatment of Prolonged Grief Disorder in Combat Veterans

ID: NCT02283333
Status: Recruiting
Phase: N/A
Start Date: December 01, 2014
First Submitted: October 23, 2014
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: VA Office of Research and Development
Location: United States
Conditions: Prolonged Grief Disorder
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Study Description

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.

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.
Condition or disease Intervention/treatment Phase

Prolonged Grief Disorder

Behavioral: BATE-G
Other Names
Behavioral: Standard Treatment
Other Names
N/A

Tracking Information

First Submitted DateOctober 23, 2014
Last Update Posted DateFebruary 23, 2018
Actual Start DateDecember 01, 2014
Anticipated Completion DateSeptember 30, 2019
Actual Primary Completion DateAugust 31, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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.

  • 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.

  • 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.

  • 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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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.

  • 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.

  • Beck Anxiety Inventory (BAI) [Time Frame: Baseline]

    This is a 21 item self-report measure that assesses anxiety levels.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.)

  • Treatment Credibility Questionnaire [Time Frame: 8 weeks]

    This questionnaire is used to assess for differences in outcome expectancy using treatment credibility scales.

  • 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.

  • 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.

  • 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.

  • Beck Anxiety Inventory (BAI) [Time Frame: 8 weeks]

    This is a 21 item self-report measure that assesses anxiety levels.

  • Beck Anxiety Inventory (BAI) [Time Frame: 3 months]

    This is a 21 item self-report measure that assesses anxiety levels.

  • Beck Anxiety Inventory (BAI) [Time Frame: 6 months]

    This is a 21 item self-report measure that assesses anxiety levels.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleTreatment of Prolonged Grief Disorder in Combat Veterans
Official TitleTreatment of Prolonged Grief Disorder in Combat Veterans
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.

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 TypeInterventional
Study PhaseN/A
Estimated Enrollment
140
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Treatment
Conditions
Prolonged Grief Disorder
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Behavioral: BATE-G

Behavioral Activation and Therapeutic Exposure - Grief therapy are delivered in 7 weekly sessions to the participant.

Other Names
Behavioral: Standard Treatment

Cognitive Restructuring and Supportive Grief Counseling are delivered in 7 weekly sessions to the participant.

Other Names
Study Groups/Cohorts
BATE-G
Behavioral Activation and Therapeutic Exposure - Grief therapy are delivered in 7 weekly sessions to the participant.

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

Study Arms
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.

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

Recruitment Information

Recruitment Status:Recruiting
Enrollment140
Completion DateSeptember 30, 2019
Eligibility 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.
GenderAll
Age21 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02283333
Other Study ID Numbers
CLNA-001-14S
CX001102
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
VA Office of Research and Development
Collaborators
Not Available
Investigators
Principal Investigator
Ron E. Acierno, PhD MS BA
Ralph H. Johnson VA Medical Center, Charleston, SC