Trial Outcomes & Findings for Treatment of PTSD in Residents of Battered Women's Shelters (NCT NCT02398227)
NCT ID: NCT02398227
Last Updated: 2018-08-10
Results Overview
Clinical Interview assessing symptoms of Posttraumatic Stress Disorder (PTSD) scores can range from 0 to 136 with higher scores reflecting greater PTSD severity Adjusted means with baseline scores as a covariate are reported
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
172 participants
Primary outcome timeframe
baseline, post-shelter, post-treatment, 6 months post-treatment, 1 year post-treatment
Results posted on
2018-08-10
Participant Flow
Participant milestones
| Measure |
HOPE
Cognitive Behavioral Treatment Program for PTSD
HOPE: Cognitive Behavioral Treatment for PTSD in Battered Women
|
Present Centered Therapy (PCT)
Present Centered Therapy for PTSD
PCT: Present Centered Therapy for PTSD
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
89
|
|
Overall Study
COMPLETED
|
56
|
71
|
|
Overall Study
NOT COMPLETED
|
27
|
18
|
Reasons for withdrawal
| Measure |
HOPE
Cognitive Behavioral Treatment Program for PTSD
HOPE: Cognitive Behavioral Treatment for PTSD in Battered Women
|
Present Centered Therapy (PCT)
Present Centered Therapy for PTSD
PCT: Present Centered Therapy for PTSD
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
12
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
|
Overall Study
Removed from treatment and dropped out
|
1
|
0
|
Baseline Characteristics
Treatment of PTSD in Residents of Battered Women's Shelters
Baseline characteristics by cohort
| Measure |
HOPE
n=83 Participants
Cognitive Behavioral Treatment Program for PTSD
HOPE: Cognitive Behavioral Treatment for PTSD in Battered Women
|
Present Centered Therapy (PCT)
n=89 Participants
Present Centered Therapy for PTSD
PCT: Present Centered Therapy for PTSD
|
Total
n=172 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
|
83 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.5 Years
n=5 Participants
|
36 Years
n=7 Participants
|
35.13 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
167 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 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
|
83 participants
n=5 Participants
|
89 participants
n=7 Participants
|
172 participants
n=5 Participants
|
|
Clinician-Administered PTSD Scale (CAPS)
|
72.11 units on a scale
STANDARD_DEVIATION 20.87 • n=5 Participants
|
77.82 units on a scale
STANDARD_DEVIATION 21.12 • n=7 Participants
|
75.06 units on a scale
STANDARD_DEVIATION 21.14 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, post-shelter, post-treatment, 6 months post-treatment, 1 year post-treatmentPopulation: Analysis include those participants who completed each follow-up time point.
Clinical Interview assessing symptoms of Posttraumatic Stress Disorder (PTSD) scores can range from 0 to 136 with higher scores reflecting greater PTSD severity Adjusted means with baseline scores as a covariate are reported
Outcome measures
| Measure |
HOPE
n=53 Participants
Cognitive Behavioral Treatment Program for PTSD
HOPE: Cognitive Behavioral Treatment for PTSD in Battered Women
|
Present Centered Therapy (PCT)
n=70 Participants
Present Centered Therapy for PTSD
PCT: Present Centered Therapy for PTSD
|
|---|---|---|
|
Clinician Administered PTSD Scale (CAPS)
post-treatment
|
31.75 units on a scale
Standard Deviation 22.47
|
34.43 units on a scale
Standard Deviation 28.33
|
|
Clinician Administered PTSD Scale (CAPS)
post-shelter
|
48.08 units on a scale
Standard Deviation 25.36
|
52.39 units on a scale
Standard Deviation 28.05
|
|
Clinician Administered PTSD Scale (CAPS)
6 month post-treatment
|
29.36 units on a scale
Standard Deviation 28.36
|
32.63 units on a scale
Standard Deviation 27.33
|
|
Clinician Administered PTSD Scale (CAPS)
1 year post-treatment
|
27.32 units on a scale
Standard Deviation 24.96
|
29.00 units on a scale
Standard Deviation 28.03
|
PRIMARY outcome
Timeframe: baseline, post-shelter, post-treatment, 6-month post-treatment, 1 year post-treatmentPopulation: Analysis only include those who completed all time-points
Severity of Violence Against Women Scale total score. Scores can range from 0 to 138 with higher scores reflecting greater degree of violence/abuse.Adjusted means with baseline scores as a covariate are reported
Outcome measures
| Measure |
HOPE
n=53 Participants
Cognitive Behavioral Treatment Program for PTSD
HOPE: Cognitive Behavioral Treatment for PTSD in Battered Women
|
Present Centered Therapy (PCT)
n=69 Participants
Present Centered Therapy for PTSD
PCT: Present Centered Therapy for PTSD
|
|---|---|---|
|
Severity of Violence Against Women Scale (SVAWS)
post-shelter
|
7.81 score on a scale
Standard Deviation 15.37
|
13.89 score on a scale
Standard Deviation 28.74
|
|
Severity of Violence Against Women Scale (SVAWS)
post-treatment
|
3.47 score on a scale
Standard Deviation 8.82
|
1.10 score on a scale
Standard Deviation 3.86
|
|
Severity of Violence Against Women Scale (SVAWS)
6-month post-shelter
|
3.42 score on a scale
Standard Deviation 13.51
|
2.73 score on a scale
Standard Deviation 8.55
|
|
Severity of Violence Against Women Scale (SVAWS)
1-year post-treatment
|
2.40 score on a scale
Standard Deviation 9.03
|
3.68 score on a scale
Standard Deviation 12.88
|
Adverse Events
HOPE
Serious events: 56 serious events
Other events: 75 other events
Deaths: 0 deaths
Present Centered Therapy (PCT)
Serious events: 56 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HOPE
n=83 participants at risk
Cognitive Behavioral Treatment Program for PTSD
HOPE: Cognitive Behavioral Treatment for PTSD in Battered Women
|
Present Centered Therapy (PCT)
n=89 participants at risk
Present Centered Therapy for PTSD
PCT: Present Centered Therapy for PTSD
|
|---|---|---|
|
Social circumstances
Life Threatening Experience or Trauma
|
33.7%
28/83 • Number of events 58 • 12-month follow-up.
12-month follow up.
|
37.1%
33/89 • Number of events 79 • 12-month follow-up.
12-month follow up.
|
|
Social circumstances
Life Threatening Experience and Sexual Assault
|
1.2%
1/83 • Number of events 1 • 12-month follow-up.
12-month follow up.
|
2.2%
2/89 • Number of events 12 • 12-month follow-up.
12-month follow up.
|
|
Psychiatric disorders
Significant Clinical Deterioration Suicidality
|
4.8%
4/83 • Number of events 8 • 12-month follow-up.
12-month follow up.
|
1.1%
1/89 • Number of events 1 • 12-month follow-up.
12-month follow up.
|
|
Psychiatric disorders
Active Homicidality
|
2.4%
2/83 • Number of events 2 • 12-month follow-up.
12-month follow up.
|
0.00%
0/89 • 12-month follow-up.
12-month follow up.
|
|
Psychiatric disorders
Psychiatric Inpatient Hospitalization
|
12.0%
10/83 • Number of events 13 • 12-month follow-up.
12-month follow up.
|
13.5%
12/89 • Number of events 18 • 12-month follow-up.
12-month follow up.
|
|
Social circumstances
Hospitalization Related to Domestic Violence
|
2.4%
2/83 • Number of events 3 • 12-month follow-up.
12-month follow up.
|
4.5%
4/89 • Number of events 9 • 12-month follow-up.
12-month follow up.
|
|
Social circumstances
Other Hospitalization
|
30.1%
25/83 • Number of events 49 • 12-month follow-up.
12-month follow up.
|
32.6%
29/89 • Number of events 62 • 12-month follow-up.
12-month follow up.
|
|
Social circumstances
Receipt of a Serious Health Diagnosis
|
3.6%
3/83 • Number of events 4 • 12-month follow-up.
12-month follow up.
|
4.5%
4/89 • Number of events 4 • 12-month follow-up.
12-month follow up.
|
|
Social circumstances
Sexual Assault
|
14.5%
12/83 • Number of events 29 • 12-month follow-up.
12-month follow up.
|
10.1%
9/89 • Number of events 21 • 12-month follow-up.
12-month follow up.
|
|
Social circumstances
Reporting to Children's Services
|
4.8%
4/83 • Number of events 5 • 12-month follow-up.
12-month follow up.
|
6.7%
6/89 • Number of events 8 • 12-month follow-up.
12-month follow up.
|
|
Social circumstances
Criminal Charge or Arrest
|
2.4%
2/83 • Number of events 2 • 12-month follow-up.
12-month follow up.
|
1.1%
1/89 • Number of events 2 • 12-month follow-up.
12-month follow up.
|
|
Social circumstances
Persistent or Significant Disability or Impairment
|
0.00%
0/83 • 12-month follow-up.
12-month follow up.
|
0.00%
0/89 • 12-month follow-up.
12-month follow up.
|
|
Social circumstances
Pregnancy Complications
|
2.4%
2/83 • Number of events 2 • 12-month follow-up.
12-month follow up.
|
2.2%
2/89 • Number of events 2 • 12-month follow-up.
12-month follow up.
|
Other adverse events
| Measure |
HOPE
n=83 participants at risk
Cognitive Behavioral Treatment Program for PTSD
HOPE: Cognitive Behavioral Treatment for PTSD in Battered Women
|
Present Centered Therapy (PCT)
n=89 participants at risk
Present Centered Therapy for PTSD
PCT: Present Centered Therapy for PTSD
|
|---|---|---|
|
Social circumstances
Non-life Threatening Abuse or Trauma
|
89.2%
74/83 • Number of events 297 • 12-month follow-up.
12-month follow up.
|
82.0%
73/89 • Number of events 280 • 12-month follow-up.
12-month follow up.
|
|
Psychiatric disorders
Substance Use
|
14.5%
12/83 • Number of events 16 • 12-month follow-up.
12-month follow up.
|
13.5%
12/89 • Number of events 15 • 12-month follow-up.
12-month follow up.
|
|
Psychiatric disorders
Significant Clinical Deterioration CAPS
|
1.2%
1/83 • Number of events 1 • 12-month follow-up.
12-month follow up.
|
5.6%
5/89 • Number of events 8 • 12-month follow-up.
12-month follow up.
|
|
Social circumstances
Confidentiality Breach
|
1.2%
1/83 • Number of events 1 • 12-month follow-up.
12-month follow up.
|
0.00%
0/89 • 12-month follow-up.
12-month follow up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place