Trial Outcomes & Findings for Effectiveness of Three Different Psychotherapies for Chronic Post-Traumatic Stress Disorder (NCT NCT00739765)
NCT ID: NCT00739765
Last Updated: 2019-03-05
Results Overview
Continuous measure scale of PTSD symptoms severity. Generally considered state of the art. Range 0-136 (17 items each rated for frequency and for intensity, each on a 0-4 scale). Scores \>50 indicate at least moderately severe PTSD; scores \<20 were defined as remission. See Blake DD, Weathers FW, Nagy LM, et al: The development of a clinician-administered PTSD scale. J Trauma Stress 1995; 8:75-90; Weathers FW, Keane TM, Davidson JRT: Clinician-Administered PTSD Scale: a review of the first ten years of research. Depression and Anxiety 2001;13:132-156
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
After 14 weeks of treatment
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
1 Interpersonal Psychotherapy (IPT)
Participants will receive interpersonal psychotherapy.
Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports
|
2 Prolonged Exposure (PE)
Participants will receive prolonged exposure therapy.
Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma
|
3 Relaxation Therapy
Participants will receive relaxation therapy.
Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
38
|
32
|
|
Overall Study
COMPLETED
|
34
|
27
|
21
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Three Different Psychotherapies for Chronic Post-Traumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
1 Interpersonal Psychotherapy (IPT)
n=40 Participants
Participants will receive interpersonal psychotherapy.
Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports
|
2 Prolonged Exposure (PE)
n=38 Participants
Participants will receive prolonged exposure therapy.
Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma
|
3 Relaxation Therapy
n=32 Participants
Participants will receive relaxation therapy.
Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.12 Years
STANDARD_DEVIATION 11.21 • n=5 Participants
|
41.76 Years
STANDARD_DEVIATION 11.99 • n=7 Participants
|
40.62 Years
STANDARD_DEVIATION 11.48 • n=5 Participants
|
40.10 Years
STANDARD_DEVIATION 11.57 • n=4 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
79 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (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
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
38 participants
n=7 Participants
|
32 participants
n=5 Participants
|
110 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: After 14 weeks of treatmentContinuous measure scale of PTSD symptoms severity. Generally considered state of the art. Range 0-136 (17 items each rated for frequency and for intensity, each on a 0-4 scale). Scores \>50 indicate at least moderately severe PTSD; scores \<20 were defined as remission. See Blake DD, Weathers FW, Nagy LM, et al: The development of a clinician-administered PTSD scale. J Trauma Stress 1995; 8:75-90; Weathers FW, Keane TM, Davidson JRT: Clinician-Administered PTSD Scale: a review of the first ten years of research. Depression and Anxiety 2001;13:132-156
Outcome measures
| Measure |
1 Interpersonal Psychotherapy (IPT)
n=40 Participants
Participants will receive interpersonal psychotherapy.
Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports
|
2 Prolonged Exposure (PE)
n=38 Participants
Participants will receive prolonged exposure therapy.
Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma
|
3 Relaxation Therapy
n=32 Participants
Participants will receive relaxation therapy.
Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD
|
|---|---|---|---|
|
Clinician-Administered PTSD Scale (CAPS)
Baseline
|
68.9 units on a scale
Standard Deviation 16.2
|
72.1 units on a scale
Standard Deviation 18.2
|
68.9 units on a scale
Standard Deviation 16.4
|
|
Clinician-Administered PTSD Scale (CAPS)
Week 14
|
39.8 units on a scale
Standard Deviation 24.3
|
37.5 units on a scale
Standard Deviation 28.8
|
46.5 units on a scale
Standard Deviation 31.0
|
SECONDARY outcome
Timeframe: After 14 weeks of treatmentContinuous scale to measure depressive symptom severity with a potential range from 0 to 74. Higher scores indicate more severe depressive symptoms. Scores \<8 are generally considered not depressed; 8-12 mildly depressed; 13-19 moderately depressed; 20 and greater, severely depressed. Reference: Hamilton M: A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;25:56-62
Outcome measures
| Measure |
1 Interpersonal Psychotherapy (IPT)
n=40 Participants
Participants will receive interpersonal psychotherapy.
Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports
|
2 Prolonged Exposure (PE)
n=38 Participants
Participants will receive prolonged exposure therapy.
Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma
|
3 Relaxation Therapy
n=32 Participants
Participants will receive relaxation therapy.
Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD
|
|---|---|---|---|
|
Hamilton Depression Rating Scale
Baseline
|
18.3 units on a scale
Standard Deviation 6.5
|
20.2 units on a scale
Standard Deviation 6.7
|
21.0 units on a scale
Standard Deviation 7.1
|
|
Hamilton Depression Rating Scale
Week 14
|
13.8 units on a scale
Standard Deviation 8.8
|
12.3 units on a scale
Standard Deviation 8.8
|
14.8 units on a scale
Standard Deviation 9.1
|
Adverse Events
1 Interpersonal Psychotherapy (IPT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Prolonged Exposure (PE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 Relaxation Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 Interpersonal Psychotherapy (IPT)
n=40 participants at risk
Participants will receive interpersonal psychotherapy.
Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports
|
2 Prolonged Exposure (PE)
n=38 participants at risk
Participants will receive prolonged exposure therapy.
Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma
|
3 Relaxation Therapy
n=32 participants at risk
Participants will receive relaxation therapy.
Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD
|
|---|---|---|---|
|
Psychiatric disorders
Clinical deterioration/protocol violation
|
0.00%
0/40 • 14 weeks; treatment responders followed to 26 weeks.
|
0.00%
0/38 • 14 weeks; treatment responders followed to 26 weeks.
|
0.00%
0/32 • 14 weeks; treatment responders followed to 26 weeks.
|
Other adverse events
Adverse event data not reported
Additional Information
John C. Markowitz, M.D.
New York State Psychiatric Institute
Phone: 646 774-8098
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place