Trial Outcomes & Findings for IOK Treatment Study (NCT NCT01605799)
NCT ID: NCT01605799
Last Updated: 2016-02-23
Results Overview
The PCL is a 17 item self-report measure of the 17 symptoms of PTSD per the DSM IV. Possible scores range from 17 (better outcome) to 85 (worse outcome).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
PTSD symptoms will be assessed at Baseline or the first study visit and the end of treatment (Week 7)
Results posted on
2016-02-23
Participant Flow
Participant milestones
| Measure |
IOK Treatment
Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
|
Wait List Control Group
Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
IOK Treatment
Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
|
Wait List Control Group
Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
IOK Treatment Study
Baseline characteristics by cohort
| Measure |
IOK Treatment
n=15 Participants
Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
|
Wait List Control Group
n=15 Participants
Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
59.9 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: PTSD symptoms will be assessed at Baseline or the first study visit and the end of treatment (Week 7)Population: The mean change in PCL score from baseline to end of treatment will be measured using an intent to treat analysis.
The PCL is a 17 item self-report measure of the 17 symptoms of PTSD per the DSM IV. Possible scores range from 17 (better outcome) to 85 (worse outcome).
Outcome measures
| Measure |
IOK Treatment
n=15 Participants
Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
|
Wait List Control Group
n=15 Participants
Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
|
|---|---|---|
|
Change in PTSD Symptoms as Measured by the PCL
|
-7.33 Units on a scale
Interval -14.71 to -0.05
|
-2.13 Units on a scale
Interval -5.97 to -1.71
|
SECONDARY outcome
Timeframe: The BSI will be administered at Baseline or the first study visit and the end of treatment (Week 7)Population: The mean change in BSI between baseline and end of treatment will be measured using an intent to treat analysis.
The BSI is a 53 item self-report scale used to measure nine primary symptom dimensions (somatization, obsessive-compulsive behavior, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism). Respondents rank each feeling item (e.g., "your feelings being easily hurt") on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Rankings characterize the intensity of distress during the past seven days. The total score is the sum of all responses \[minimum = 0 (better outcome), maximum = 212 (worse outcome)\].
Outcome measures
| Measure |
IOK Treatment
n=15 Participants
Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
|
Wait List Control Group
n=15 Participants
Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
|
|---|---|---|
|
Change in Psychological Symptoms as Measured by the Brief Symptom Inventory (BSI-53)
|
-17.73 Units on a scale
Interval -32.87 to -2.6
|
4.53 Units on a scale
Interval -6.65 to 15.71
|
Adverse Events
IOK Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait List Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place