Posttraumatic Stress DisorderPhase 2NCT01605799
IOK Treatment Study
A Phase 2 study testing IOK Killing Treatment in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The goals of this project are 1) to evaluate the effectiveness of a CBT treatment module addressing the mental health and functional impact of killing in the war zone, 2) to gather data on Veteran stakeholders' perceptions of acceptability and feasibility of the CBT treatment module, which would be used to further… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- IOK Killing Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jan 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Combat Veterans ranging in age from 18-70 years will be recruited to participate in this study. Combat veterans ranging in age from 70 to 90 years will also be considered for enrollment in the study on a case-by-case basis.
- Veterans will need to endorse having taken a life in a war zone context, to meet criteria for PTSD, and to have received some prior treatment for PTSD to be included in the study.
- Participants in current PTSD treatment will not be excluded; however, if receiving medications, they will need to be stabilized on current medications for at least one month.
- If receiving Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT), the two treatments the VA recognizes as evidence-based treatment for PTSD, individuals will need to wait two weeks after they have completed the treatment in order to enroll in the study, and new baseline measures will be obtained at that time.
Who cannot join
- Potential participants will only be excluded if they meet current or lifetime criteria for a psychotic disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121
About this study
Official title: A Novel PTSD Treatment for Veterans Who Killed in War
The goals of this project are
- 1) to evaluate the effectiveness of a CBT treatment module addressing the mental health and functional impact of killing in the war zone,
- 2) to gather data on Veteran stakeholders' perceptions of acceptability and feasibility of the CBT treatment module, which would be used to further refine the intervention, and
- 3) to gather data on clinician stakeholders' perceptions of acceptability and feasibility of the CBT treatment module, which would be used to ensure that the module could be easily integrated into EBT for PTSD.
Read the detailed description
Background: There is mounting evidence that Veterans from multiple eras who kill in war are at increased risk for posttraumatic stress disorder (PTSD), alcohol abuse, suicide, and functional difficulties after returning home. Despite high rates of exposure to killing and associated maladaptive responses, the military and VA do not routinely assess exposure to killing, which could assist with prevention and treatment efforts. Furthermore, the impact of killing is not currently addressed as a component of evidence-based treatment (EBT) for PTSD. In fact, in the current system, a Veteran can receive PTSD evaluation and evidence-based treatment without ever being asked about killing and its impact. Some researchers have cautioned against using one type of PTSD treatment, one commonly used in the VA, suggesting that it may be harmful for these patients. Consequently, it is possible that failing to directly treat the mental health impact of killing could result in inappropriate treatment, cause harm to Veterans, and cost lives.
Objectives: Our first aim is to evaluate the effectiveness of a CBT treatment module addressing the mental health and functional impact of killing in the war zone, which would be added onto existing EBT for PTSD. Our second aim is to gather data on Veteran stakeholders' perceptions of acceptability and feasibility of the CBT treatment module, which would be used to further refine the intervention. Our third aim is to gather data on clinician stakeholders' perceptions of acceptability and feasibility of the CBT treatment module, which would be used to ensure that the module could be easily integrated into EBT for PTSD.
Methods: The investigators propose a 12-month pilot, cross-sectional Hybrid Type 2 study, given that The investigators will be adding a treatment module to existing EBT for PTSD. The investigators will conduct a randomized, controlled effectiveness trial to better understand if the six-week treatment module addressing the impact of killing has added benefit, compared to PTSD treatment as usual (N = 50). The investigators will employ a concurrent design mixed method study to test the perceptions of Veteran stakeholders who receive the treatment module, obtaining ratings of acceptability and feasibility through self-report measures and interviews. The investigators also will interview clinicians who provide EBT for PTSD, and interviews will be guided by Roger's five intrinsic characteristics, as outlined in his Diffusion of Innovations Theory.
Impact: Through involving Veteran and clinician stakeholders, the main impact of this project will be to obtain information that will assist in revising the CBT treatment module and help prepare for implementing the module in already existing settings, where EBT for PTSD is provided.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- IOK Killing Treatment, Wait list control group
- Keywords
- PTSD, Mental Health, War, Veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOK Killing TreatmentBehavioural
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 groupBehavioural
Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
| Study group | Role | What they receive |
|---|---|---|
| IOK Treatment | Active comparator | Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war. Receives: Behavioral: IOK Killing Treatment |
| Wait list control group | Placebo comparator | Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment. Receives: Behavioral: IOK Killing Treatment; Behavioral: Wait list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Symptoms as Measured by the PCL
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).
Measured: PTSD symptoms will be assessed at Baseline or the first study visit and the end of treatment (Week 7)
Secondary outcomes (1)
Change in Psychological Symptoms as Measured by the Brief Symptom Inventory (BSI-53)
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)].
Measured: The BSI will be administered at Baseline or the first study visit and the end of treatment (Week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Shira Maguen, PhD, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605799
- Sponsor's protocol ID
- RRP 12-237
- Status last verified
- Jan 2016
- First submitted
- 18 May 2012
- Last updated
- 23 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Maguen S, Burkman K. Combat-Related Killing: Expanding Evidence-Based Treatments for PTSD. Cognitive and behavioral practice. 2013 Nov 1; 20(4):476-479.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel PTSD Treatment for Veterans Who Killed in War
- ClinicalTrials.gov ID
- NCT01605799
- Acronym / sponsor ID
- RRP 12-237
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, Mental Health, War, Veterans
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Posted 17 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of this project are
- 1) to evaluate the effectiveness of a CBT treatment module addressing the mental health and functional impact of killing in the war zone,
- 2) to gather data on Veteran stakeholders' perceptions of acceptability and feasibility of the CBT treatment module, which would be used to further refine the intervention, and
- 3) to gather data on clinician stakeholders' perceptions of acceptability and feasibility of the CBT treatment module, which would be used to ensure that the module could be easily integrated into EBT for PTSD.
Detailed description
Background: There is mounting evidence that Veterans from multiple eras who kill in war are at increased risk for posttraumatic stress disorder (PTSD), alcohol abuse, suicide, and functional difficulties after returning home. Despite high rates of exposure to killing and associated maladaptive responses, the military and VA do not routinely assess exposure to killing, which could assist with prevention and treatment efforts. Furthermore, the impact of killing is not currently addressed as a component of evidence-based treatment (EBT) for PTSD. In fact, in the current system, a Veteran can receive PTSD evaluation and evidence-based treatment without ever being asked about killing and its impact. Some researchers have cautioned against using one type of PTSD treatment, one commonly used in the VA, suggesting that it may be harmful for these patients. Consequently, it is possible that failing to directly treat the mental health impact of killing could result in inappropriate treatment, cause harm to Veterans, and cost lives.
Objectives: Our first aim is to evaluate the effectiveness of a CBT treatment module addressing the mental health and functional impact of killing in the war zone, which would be added onto existing EBT for PTSD. Our second aim is to gather data on Veteran stakeholders' perceptions of acceptability and feasibility of the CBT treatment module, which would be used to further refine the intervention. Our third aim is to gather data on clinician stakeholders' perceptions of acceptability and feasibility of the CBT treatment module, which would be used to ensure that the module could be easily integrated into EBT for PTSD.
Methods: The investigators propose a 12-month pilot, cross-sectional Hybrid Type 2 study, given that The investigators will be adding a treatment module to existing EBT for PTSD. The investigators will conduct a randomized, controlled effectiveness trial to better understand if the six-week treatment module addressing the impact of killing has added benefit, compared to PTSD treatment as usual (N = 50). The investigators will employ a concurrent design mixed method study to test the perceptions of Veteran stakeholders who receive the treatment module, obtaining ratings of acceptability and feasibility through self-report measures and interviews. The investigators also will interview clinicians who provide EBT for PTSD, and interviews will be guided by Roger's five intrinsic characteristics, as outlined in his Diffusion of Innovations Theory.
Impact: Through involving Veteran and clinician stakeholders, the main impact of this project will be to obtain information that will assist in revising the CBT treatment module and help prepare for implementing the module in already existing settings, where EBT for PTSD is provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOK Treatment | Active comparator | Behavioral: IOK Killing TreatmentSix to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war. |
| Wait list control group | Placebo comparator | Behavioral: IOK Killing Treatment, Behavioral: Wait list control groupParticipants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Combat Veterans ranging in age from 18-70 years will be recruited to participate in this study. Combat veterans ranging in age from 70 to 90 years will also be considered for enrollment in the study on a case-by-case basis.
- Veterans will need to endorse having taken a life in a war zone context, to meet criteria for PTSD, and to have received some prior treatment for PTSD to be included in the study.
- Participants in current PTSD treatment will not be excluded; however, if receiving medications, they will need to be stabilized on current medications for at least one month.
- If receiving Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT), the two treatments the VA recognizes as evidence-based treatment for PTSD, individuals will need to wait two weeks after they have completed the treatment in order to enroll in the study, and new baseline measures will be obtained at that time.
Key exclusion criteria (1 listed)
- Potential participants will only be excluded if they meet current or lifetime criteria for a psychotic disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOK Killing TreatmentThe IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war. | Behavioural | IOK Treatment, Wait list control group |
| Wait list control groupParticipants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment. | Behavioural | Wait list control group |
Primary outcome
Change in PTSD Symptoms as Measured by the PCL
Time frame: PTSD symptoms will be assessed at Baseline or the first study visit and the end of treatment (Week 7)
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).
1 secondary outcome
Change in Psychological Symptoms as Measured by the Brief Symptom Inventory (BSI-53)
Time frame: The BSI will be administered at Baseline or the first study visit and the end of treatment (Week 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationMaguen S, Burkman K. Combat-Related Killing: Expanding Evidence-Based Treatments for PTSD. Cognitive and behavioral practice. 2013 Nov 1; 20(4):476-479.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shira Maguen, PhD principal investigator
San Francisco VA Medical Center, San Francisco, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IOK Killing Treatment in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Symptoms as Measured by the PCL (time frame: PTSD symptoms will be assessed at Baseline or the first study visit and the end of treatment (Week 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01605799, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.