Trial Outcomes & Findings for Treatment of Prolonged Grief Disorder in Combat Veterans (NCT NCT02283333)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

155 participants

Primary outcome timeframe

Baseline

Results posted on

2021-02-18

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	77	78
Overall Study COMPLETED	63	64
Overall Study NOT COMPLETED	14	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Prolonged Grief Disorder in Combat Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BATE-G n=77 Participants 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.	Standard Treatment n=78 Participants 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.	Total n=155 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=5 Participants	65 Participants n=7 Participants	135 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Age, Continuous	46.01 years STANDARD_DEVIATION 12.24 • n=5 Participants	47.35 years STANDARD_DEVIATION 13.13 • n=7 Participants	46.68 years STANDARD_DEVIATION 12.67 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	65 Participants n=7 Participants	126 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	70 Participants n=5 Participants	74 Participants n=7 Participants	144 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	42 Participants n=5 Participants	45 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	28 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	77 Participants n=5 Participants	78 Participants n=7 Participants	155 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Veterans

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.

Outcome measures

Outcome measures
Measure	BATE-G n=77 Participants 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.	Standard Treatment n=78 Participants 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.
Inventory of Complicated Grief - Revised (ICG-R)	93.15 score on a scale Standard Deviation 19.79	93.10 score on a scale Standard Deviation 21.59

PRIMARY outcome

Timeframe: 8 weeks

Population: veterans

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.

Outcome measures

Outcome measures
Measure	BATE-G n=77 Participants 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.	Standard Treatment n=78 Participants 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.
Inventory of Complicated Grief - Revised (ICG-R)	78.8 score on a scale Standard Deviation 19.4	78.6 score on a scale Standard Deviation 21.2

PRIMARY outcome

Timeframe: 3 months

Population: veterans

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.

Outcome measures

Outcome measures
Measure	BATE-G n=77 Participants 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.	Standard Treatment n=78 Participants 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.
Inventory of Complicated Grief - Revised (ICG-R)	79.4 score on a scale Standard Deviation 22.7	81.4 score on a scale Standard Deviation 22.8

PRIMARY outcome

Timeframe: 6 months

Population: veterans

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.

Outcome measures

Outcome measures
Measure	BATE-G n=77 Participants 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.	Standard Treatment n=78 Participants 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.
Inventory of Complicated Grief - Revised (ICG-R)	78.6 score on a scale Standard Deviation 22.9	80.0 score on a scale Standard Deviation 21.4

SECONDARY outcome

Timeframe: Baseline

Population: veterans

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.

Outcome measures

Outcome measures
Measure	BATE-G n=77 Participants 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.	Standard Treatment n=78 Participants 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.
Beck Depression Inventory - II (BDI-II)	28.5 score on a scale Standard Deviation 11.8	28.8 score on a scale Standard Deviation 14.0

SECONDARY outcome

Timeframe: Baseline

Population: veterans

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.

Outcome measures

Outcome measures
Measure	BATE-G n=77 Participants 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.	Standard Treatment n=78 Participants 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.
PTSD Checklist for DSM-5 (PCL 5)	48.0 score on a scale Standard Deviation 15.1	46.2 score on a scale Standard Deviation 16.5

SECONDARY outcome

Timeframe: 8 weeks

Population: veterans

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.

Outcome measures

Outcome measures
Measure	BATE-G n=77 Participants 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.	Standard Treatment n=78 Participants 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.
Beck Depression Inventory - II (BDI-II)	23.0 score on a scale Standard Deviation 11.6	22.1 score on a scale Standard Deviation 10.9

SECONDARY outcome

Timeframe: 3 months

Population: veterans

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.

Outcome measures

Outcome measures
Measure	BATE-G n=77 Participants 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.	Standard Treatment n=78 Participants 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.
Beck Depression Inventory - II (BDI-II)	22.0 score on a scale Standard Deviation 10.5	22.2 score on a scale Standard Deviation 11.2

SECONDARY outcome

Timeframe: 6 months

Population: veterans

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.

Outcome measures

Outcome measures
Measure	BATE-G n=77 Participants 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.	Standard Treatment n=78 Participants 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.
Beck Depression Inventory - II (BDI-II)	21.1 score on a scale Standard Deviation 11.2	23.4 score on a scale Standard Deviation 11.3

SECONDARY outcome

Timeframe: 8 weeks

Population: veterans

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.

Outcome measures

Outcome measures
Measure	BATE-G n=77 Participants 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.	Standard Treatment n=78 Participants 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.
PTSD Checklist for DSM-5 (PCL 5)	34.5 score on a scale Standard Deviation 15.8	33.9 score on a scale Standard Deviation 16.5

SECONDARY outcome

Timeframe: 3 months

Population: veterans

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.

Outcome measures

Outcome measures
Measure	BATE-G n=77 Participants 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.	Standard Treatment n=78 Participants 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.
PTSD Checklist for DSM-5 (PCL 5)	35.3 score on a scale Standard Deviation 16.8	37.6 score on a scale Standard Deviation 16.3

SECONDARY outcome

Timeframe: 6 months

Population: veterans

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.

Outcome measures

Outcome measures
Measure	BATE-G n=77 Participants 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.	Standard Treatment n=78 Participants 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.
PTSD Checklist for DSM-5 (PCL 5)	33.3 score on a scale Standard Deviation 16.7	36.0 score on a scale Standard Deviation 14.6

Adverse Events

BATE-G

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BATE-G n=77 participants at risk 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.	Standard Treatment n=78 participants at risk 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.
Psychiatric disorders Serious Adverse Event	0.00% 0/77 • Adverse event data was collected for a period of 5 years, 1 month. Adverse events and serious adverse events were recorded in accordance with clinicaltrials.gov definitions.	1.3% 1/78 • Adverse event data was collected for a period of 5 years, 1 month. Adverse events and serious adverse events were recorded in accordance with clinicaltrials.gov definitions.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ron Acierno, PI

Ralph H. Johnson VA Medical Center

Phone: 843-364-1667

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place