Prolonged Grief Disorder
Conditions
Keywords
Behavioral Activation, Therapeutic Exposure, Mental Health, Veterans, Complicated Grief, Military, Treatment, Cognitive Therapy, Bereavement, Complicated Bereavement
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.
Interventions
BEHAVIORALBATE-G
Behavioral Activation and Therapeutic Exposure - Grief therapy is delivered in 7 weekly sessions to the participant.
BEHAVIORALStandard Treatment
Cognitive Restructuring and Supportive Grief Counseling is delivered in 7 weekly sessions to the participant.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inventory of Complicated Grief - Revised (ICG-R) | Baseline | The Inventory of Complicated Grief (ICG) Revised is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. It has 34 items with scores ranging from 30 to 150. Min score 50; max score 143 indicated at baseline. Higher scores indicate worse outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory - II (BDI-II) | Baseline | Beck Depression Inventory-II is a 21 item measure of depressive severity with scores ranging from 0 to 63. Min score 0; max score 61 indicated at baseline. Higher scores indicate worse outcomes. |
| PTSD Checklist for DSM-5 (PCL 5) | Baseline | The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD with scores ranging from 0 to 80. 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. Min score 2; max score 76 indicated at baseline. Higher scores indicate worse outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BATE-G Behavioral Activation and Therapeutic Exposure - Grief therapy are delivered in 7 weekly sessions to the participant.
BATE-G: Behavioral Activation and Therapeutic Exposure - Grief therapy is delivered in 7 weekly sessions to the participant. | 77 |
| Standard Treatment Cognitive Restructuring and Supportive Grief Counseling are delivered in 7 weekly sessions to the participant.
Standard Treatment: Cognitive Restructuring and Supportive Grief Counseling is delivered in 7 weekly sessions to the participant. | 78 |
| Total | 155 |
Baseline characteristics
| Characteristic | BATE-G | Standard Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 13 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 65 Participants | 135 Participants |
| Age, Continuous | 46.01 years STANDARD_DEVIATION 12.24 | 47.35 years STANDARD_DEVIATION 13.13 | 46.68 years STANDARD_DEVIATION 12.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 4 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants | 74 Participants | 144 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 42 Participants | 45 Participants | 87 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 28 Participants | 52 Participants |
| Region of Enrollment United States | 77 Participants | 78 Participants | 155 Participants |
| Sex: Female, Male Female | 16 Participants | 13 Participants | 29 Participants |
| Sex: Female, Male Male | 61 Participants | 65 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 78 |
| other Total, other adverse events | 0 / 77 | 0 / 78 |
| serious Total, serious adverse events | 0 / 77 | 1 / 78 |
Outcome results
Primary
Inventory of Complicated Grief - Revised (ICG-R)
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 34 items with scores ranging from 30 to 150. Min score 30; max score 141 indicated at 6 month. Higher scores indicate worse outcomes.
Time frame: 6 months
Population: veterans
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BATE-G | Inventory of Complicated Grief - Revised (ICG-R) | 78.6 score on a scale | Standard Deviation 22.9 |
| Standard Treatment | Inventory of Complicated Grief - Revised (ICG-R) | 80.0 score on a scale | Standard Deviation 21.4 |
Primary
Inventory of Complicated Grief - Revised (ICG-R)
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 34 items with scores ranging from 30 to 150. Min score 31.97; max score 150 indicated at 3 month. Higher scores indicate worse outcomes.
Time frame: 3 months
Population: veterans
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BATE-G | Inventory of Complicated Grief - Revised (ICG-R) | 79.4 score on a scale | Standard Deviation 22.7 |
| Standard Treatment | Inventory of Complicated Grief - Revised (ICG-R) | 81.4 score on a scale | Standard Deviation 22.8 |
Primary
Inventory of Complicated Grief - Revised (ICG-R)
The Inventory of Complicated Grief (ICG) Revised is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. It has 34 items with scores ranging from 30 to 150. Min score 50; max score 143 indicated at baseline. Higher scores indicate worse outcomes.
Time frame: Baseline
Population: Veterans
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BATE-G | Inventory of Complicated Grief - Revised (ICG-R) | 93.15 score on a scale | Standard Deviation 19.79 |
| Standard Treatment | Inventory of Complicated Grief - Revised (ICG-R) | 93.10 score on a scale | Standard Deviation 21.59 |
Primary
Inventory of Complicated Grief - Revised (ICG-R)
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 34 items with scores ranging from 30 to 150. Min score 33.31; max score 133 indicated at post. Higher scores indicate worse outcomes.
Time frame: 8 weeks
Population: veterans
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BATE-G | Inventory of Complicated Grief - Revised (ICG-R) | 78.8 score on a scale | Standard Deviation 19.4 |
| Standard Treatment | Inventory of Complicated Grief - Revised (ICG-R) | 78.6 score on a scale | Standard Deviation 21.2 |
Secondary
Beck Depression Inventory - II (BDI-II)
Beck Depression Inventory-II is a 21 item measure of depressive severity with scores ranging from 0 to 63. Min score 0; max score 58 indicated at 6 month. Higher scores indicate worse outcomes.
Time frame: 6 months
Population: veterans
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BATE-G | Beck Depression Inventory - II (BDI-II) | 21.1 score on a scale | Standard Deviation 11.2 |
| Standard Treatment | Beck Depression Inventory - II (BDI-II) | 23.4 score on a scale | Standard Deviation 11.3 |
Secondary
Beck Depression Inventory - II (BDI-II)
Beck Depression Inventory-II is a 21 item measure of depressive severity with scores ranging from 0 to 63. Min score 0; max score 61 indicated at baseline. Higher scores indicate worse outcomes.
Time frame: Baseline
Population: veterans
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BATE-G | Beck Depression Inventory - II (BDI-II) | 28.5 score on a scale | Standard Deviation 11.8 |
| Standard Treatment | Beck Depression Inventory - II (BDI-II) | 28.8 score on a scale | Standard Deviation 14 |
Secondary
Beck Depression Inventory - II (BDI-II)
Beck Depression Inventory-II is a 21 item measure of depressive severity with scores ranging from 0 to 63. Min score 0; max score 58 indicated at post. Higher scores indicate worse outcomes.
Time frame: 8 weeks
Population: veterans
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BATE-G | Beck Depression Inventory - II (BDI-II) | 23.0 score on a scale | Standard Deviation 11.6 |
| Standard Treatment | Beck Depression Inventory - II (BDI-II) | 22.1 score on a scale | Standard Deviation 10.9 |
Secondary
Beck Depression Inventory - II (BDI-II)
Beck Depression Inventory-II is a 21 item measure of depressive severity with scores ranging from 0 to 63. Min score 0; max score 52 indicated at 3 month. Higher scores indicate worse outcomes.
Time frame: 3 months
Population: veterans
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BATE-G | Beck Depression Inventory - II (BDI-II) | 22.0 score on a scale | Standard Deviation 10.5 |
| Standard Treatment | Beck Depression Inventory - II (BDI-II) | 22.2 score on a scale | Standard Deviation 11.2 |
Secondary
PTSD Checklist for DSM-5 (PCL 5)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD with scores ranging from 0 to 80. 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. Min score 2; max score 76 indicated at baseline. Higher scores indicate worse outcomes.
Time frame: Baseline
Population: veterans
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BATE-G | PTSD Checklist for DSM-5 (PCL 5) | 48.0 score on a scale | Standard Deviation 15.1 |
| Standard Treatment | PTSD Checklist for DSM-5 (PCL 5) | 46.2 score on a scale | Standard Deviation 16.5 |
Secondary
PTSD Checklist for DSM-5 (PCL 5)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD with scores ranging from 0 to 80. 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. Min score 0; max score 72 indicated at post. Higher scores indicate worse outcomes.
Time frame: 8 weeks
Population: veterans
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BATE-G | PTSD Checklist for DSM-5 (PCL 5) | 34.5 score on a scale | Standard Deviation 15.8 |
| Standard Treatment | PTSD Checklist for DSM-5 (PCL 5) | 33.9 score on a scale | Standard Deviation 16.5 |
Secondary
PTSD Checklist for DSM-5 (PCL 5)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD with scores ranging from 0 to 80. 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. Min score 0; max score 76 indicated at 3 month. Higher scores indicate worse outcomes.
Time frame: 3 months
Population: veterans
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BATE-G | PTSD Checklist for DSM-5 (PCL 5) | 35.3 score on a scale | Standard Deviation 16.8 |
| Standard Treatment | PTSD Checklist for DSM-5 (PCL 5) | 37.6 score on a scale | Standard Deviation 16.3 |
Secondary
PTSD Checklist for DSM-5 (PCL 5)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD with scores ranging from 0 to 80. 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. Min score 0; max score 76 indicated at 6 month. Higher scores indicate worse outcomes.
Time frame: 6 months
Population: veterans
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BATE-G | PTSD Checklist for DSM-5 (PCL 5) | 33.3 score on a scale | Standard Deviation 16.7 |
| Standard Treatment | PTSD Checklist for DSM-5 (PCL 5) | 36.0 score on a scale | Standard Deviation 14.6 |