Trial Outcomes & Findings for A Study of Medication With or Without Psychotherapy for Complicated Grief (NCT NCT01179568)
NCT ID: NCT01179568
Last Updated: 2017-01-24
Results Overview
Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief was be used. Response is defined as a score of 1(very much improved) or 2 (much improved) on the scale. The rating was done by an Independent Evaluator.
COMPLETED
PHASE2
395 participants
Weeks 12 and 20
2017-01-24
Participant Flow
Bereaved individuals age 18-95 were recruited between March 2010 and September 2014 using professional and public outreach, print, broadcast and internet media. Referrals were made by health care professionals, bereavement counselors and patients or family members.
Participant milestones
| Measure |
Citalopram
Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
Placebo (Sugar Pill)
Inactive medication. It is combined with grief-focused clinical management.
Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion.
|
CGT With Citalopram
The targeted psychotherapy for complicated grief combined with SSRI medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
CGT With Placebo
The targeted psychotherapy for complicated grief combined with inactive medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
101
|
99
|
99
|
96
|
|
Overall Study
Completed Week 12 Assessment
|
69
|
69
|
76
|
75
|
|
Overall Study
COMPLETED
|
73
|
61
|
76
|
76
|
|
Overall Study
NOT COMPLETED
|
28
|
38
|
23
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Medication With or Without Psychotherapy for Complicated Grief
Baseline characteristics by cohort
| Measure |
Citalopram
n=101 Participants
Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
Placebo (Sugar Pill)
n=99 Participants
Inactive medication. It is combined with grief-focused clinical management.
Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion.
|
CGT With Citalopram
n=99 Participants
The targeted psychotherapy for complicated grief combined with SSRI medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
CGT With Placebo
n=96 Participants
The targeted psychotherapy for complicated grief combined with inactive medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.
|
Total
n=395 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
53.9 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
52.1 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 16.0 • n=4 Participants
|
53.0 years
STANDARD_DEVIATION 14.5 • n=21 Participants
|
|
Gender
Female
|
82 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
308 Participants
n=21 Participants
|
|
Gender
Male
|
19 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
350 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
While
|
85 participants
n=5 Participants
|
80 participants
n=7 Participants
|
81 participants
n=5 Participants
|
79 participants
n=4 Participants
|
325 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
11 participants
n=5 Participants
|
10 participants
n=4 Participants
|
39 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Others
|
6 participants
n=5 Participants
|
11 participants
n=7 Participants
|
7 participants
n=5 Participants
|
7 participants
n=4 Participants
|
31 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Weeks 12 and 20Population: Response rates were compared under the intention-to-treat principle, including all randomized participants in a logistic regression with inverse probability weighting .
Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief was be used. Response is defined as a score of 1(very much improved) or 2 (much improved) on the scale. The rating was done by an Independent Evaluator.
Outcome measures
| Measure |
Citalopram (CIT)
n=101 Participants
Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
Placebo (PLA; Sugar Pill)
n=99 Participants
Inactive medication. It is combined with grief-focused clinical management.
Placebo (PLA): 16 weeks of daily inactive medication. It is administered in a double-blind fashion.
|
Complicated Grief Treatment With Citalopram (CGT With CIT)
n=99 Participants
The targeted psychotherapy for complicated grief combined with SSRI medication.
Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
Complicated Grief Treatment With Placebo (CGT With PLA)
n=96 Participants
The targeted psychotherapy for complicated grief combined with inactive medication.
Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.
|
|---|---|---|---|---|
|
Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale
|
46 percentage of responders
|
38 percentage of responders
|
84 percentage of responders
|
83 percentage of responders
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.
The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.
Outcome measures
| Measure |
Citalopram (CIT)
n=101 Participants
Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
Placebo (PLA; Sugar Pill)
n=99 Participants
Inactive medication. It is combined with grief-focused clinical management.
Placebo (PLA): 16 weeks of daily inactive medication. It is administered in a double-blind fashion.
|
Complicated Grief Treatment With Citalopram (CGT With CIT)
The targeted psychotherapy for complicated grief combined with SSRI medication.
Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
Complicated Grief Treatment With Placebo (CGT With PLA)
The targeted psychotherapy for complicated grief combined with inactive medication.
Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.
|
|---|---|---|---|---|
|
Change From Baseline in Inventory of Complicated Grief (ICG)
|
18 score change from baseline to wk12
Standard Deviation 11
|
16 score change from baseline to wk12
Standard Deviation 12
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 20Population: Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.
The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.
Outcome measures
| Measure |
Citalopram (CIT)
n=101 Participants
Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
Placebo (PLA; Sugar Pill)
n=99 Participants
Inactive medication. It is combined with grief-focused clinical management.
Placebo (PLA): 16 weeks of daily inactive medication. It is administered in a double-blind fashion.
|
Complicated Grief Treatment With Citalopram (CGT With CIT)
n=96 Participants
The targeted psychotherapy for complicated grief combined with SSRI medication.
Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
Complicated Grief Treatment With Placebo (CGT With PLA)
The targeted psychotherapy for complicated grief combined with inactive medication.
Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.
|
|---|---|---|---|---|
|
Change From Baseline in Inventory of Complicated Grief (ICG)
|
20 score change from baseline to wk20
Standard Deviation 12
|
25 score change from baseline to wk20
Standard Deviation 14
|
26 score change from baseline to wk20
Standard Deviation 12
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.
The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.
Outcome measures
| Measure |
Citalopram (CIT)
n=101 Participants
Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
Placebo (PLA; Sugar Pill)
n=99 Participants
Inactive medication. It is combined with grief-focused clinical management.
Placebo (PLA): 16 weeks of daily inactive medication. It is administered in a double-blind fashion.
|
Complicated Grief Treatment With Citalopram (CGT With CIT)
The targeted psychotherapy for complicated grief combined with SSRI medication.
Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
Complicated Grief Treatment With Placebo (CGT With PLA)
The targeted psychotherapy for complicated grief combined with inactive medication.
Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.
|
|---|---|---|---|---|
|
Change From Baseline in Work and Social Adjustment Scale (WSAS)
|
10 score change from baseline to wk12
Standard Deviation 11
|
8 score change from baseline to wk12
Standard Deviation 10
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 20Population: Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.
The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.
Outcome measures
| Measure |
Citalopram (CIT)
n=101 Participants
Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
Placebo (PLA; Sugar Pill)
n=99 Participants
Inactive medication. It is combined with grief-focused clinical management.
Placebo (PLA): 16 weeks of daily inactive medication. It is administered in a double-blind fashion.
|
Complicated Grief Treatment With Citalopram (CGT With CIT)
n=96 Participants
The targeted psychotherapy for complicated grief combined with SSRI medication.
Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
Complicated Grief Treatment With Placebo (CGT With PLA)
The targeted psychotherapy for complicated grief combined with inactive medication.
Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.
|
|---|---|---|---|---|
|
Change From Baseline in Work and Social Adjustment Scale (WSAS)
|
10 score change from baseline to wk20
Standard Deviation 12
|
14 score change from baseline to wk20
Standard Deviation 10
|
16 score change from baseline to wk20
Standard Deviation 11
|
—
|
Adverse Events
Citalopram
Placebo (Sugar Pill)
CGT With Citalopram
CGT With Placebo
Serious adverse events
| Measure |
Citalopram
n=101 participants at risk
Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
Placebo (Sugar Pill)
n=99 participants at risk
Inactive medication. It is combined with grief-focused clinical management.
Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion.
|
CGT With Citalopram
n=99 participants at risk
The targeted psychotherapy for complicated grief combined with SSRI medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
|
CGT With Placebo
n=96 participants at risk
The targeted psychotherapy for complicated grief combined with inactive medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
death by suicide
|
0.00%
0/101 • 5 years
We observed no serious adverse medication effects. CGT therapists monitored participant response to emotionally activating procedures; no serious untoward responses were documented.
|
0.00%
0/99 • 5 years
We observed no serious adverse medication effects. CGT therapists monitored participant response to emotionally activating procedures; no serious untoward responses were documented.
|
1.0%
1/99 • Number of events 1 • 5 years
We observed no serious adverse medication effects. CGT therapists monitored participant response to emotionally activating procedures; no serious untoward responses were documented.
|
0.00%
0/96 • 5 years
We observed no serious adverse medication effects. CGT therapists monitored participant response to emotionally activating procedures; no serious untoward responses were documented.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place