Posttraumatic Stress DisorderNCT01861769
Implementation of Evidence-based Psychotherapy for PTSD
A study testing Technology-enhanced Teleconsultation and Standard Teleconsultation in people with Posttraumatic Stress Disorder, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
Approximately 9% of Canadians will have Posttraumatic Stress Disorder (PTSD) in their lifetime. In the military veteran population, the lifetime prevalence of PTSD has been estimated to be as high as 20%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Technology-enhanced Teleconsultation and Standard Teleconsultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinician participants (n=120) recruited for this study will either be Operation Stress Injury (OSI) network clinicians, Operational Trauma and Stress Support Centre (OTSSC) network clinicians or community-based clinicians who treat military-related PTSD.
- Both male and female clinician participants will be recruited;
- Clinician participants will be greater than 18 years.
- Mental health clinicians from the clinics and private practitioners will be eligible to participate in the study if they:
- attend the CPT workshop;
- are employees of an OSI or OTSSC clinic, are registered VAC clinicians, or are in private practice treating individuals with military-related PTSD;
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- currently provide psychotherapy to military soldiers or veterans with PTSD;
- consent to be randomized to one of the three study conditions; and,
- are willing to solicit patient participation.
- Eligible patient participants are:
- client of the clinician participant, who has a diagnosis of PTSD, as determined by clinician independent assessment, and total PCL score equal or greater to 45; and
- willing to consent to have their sessions audiorecorded and listened to by a fidelity rater and potentially other clinicians teaching and learning CPT. Patients are permitted to continue other psychotherapeutic interventions if not specifically focused on treating PTSD symptoms. Patient participants must be over the age of 18.
Who cannot join
- Ineligible patients will include those not eligible for CPT based on the state of research evidence, including those with:
- current uncontrolled psychotic or bipolar disorder;
- unremitted substance dependence diagnosis (substance abuse allowed);
- current imminent suicidality or homicidality that requires imminent attention; and
- significant cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Edmonton Operational Stress Injury Clinic
Edmonton, Alberta, T5E 5R8
About this study
Official title: Implementation of Evidence-based Psychotherapy for PTSD: An Empirical Investigation of Post-workshop Consultation in Treatment Fidelity and Patient Outcomes
Approximately 9% of Canadians will have Posttraumatic Stress Disorder (PTSD) in their lifetime. In the military veteran population, the lifetime prevalence of PTSD has been estimated to be as high as 20%. Numerous research studies have demonstrated that short-term, cognitive-behavioral psychotherapies, such as Cognitive Processing Therapy (CPT), lead to substantial improvements in PTSD symptoms. However, research suggests that a minority of clinicians provide these therapies in clinical settings. The transfer of this research knowledge into clinical settings remains one of the largest hurdles to improving the health of Canadians with PTSD.
It is well established that attending a 2-day workshop on these therapies alone is insufficient to promote adequate knowledge transfer and sustained skillful use. The current study aims to contrast whether two forms of post-workshop support (6-month duration), with different levels of expert oversight, will result in superior levels of clinician skill and patient outcomes versus no formal post-workshop support. The three forms of post-workshop support are 1) technology-enhanced group tele-consultation 2) standard group tele-consultation 3) no tele consultation. The primary and secondary outcomes will be the assessment of the clinicians' competence in CPT and patient symptoms,respectively. This study will inform how best to transfer evidence based therapy outcomes to the clinical milieu to attain comparable outcomes as those observed in research.
The investigators' hypotheses are as follows: Hypothesis 1:The technology enhanced group tele-consultation condition will evidence the highest levels of fidelity, the standard group tele-consultation condition will evidence intermediate levels of fidelity, and the no-consultation/fidelity monitoring only condition will evidence the lowest fidelity. Hypothesis 2: Fidelity to the CPT protocol, irrespective of consultation condition, will be positively associated with improved client outcomes. Hypothesis 3: Organizational context variables, such as the organizational climate and readiness for change, will influence the uptake of CPT skills, as well as the extent to which these skills are utilized in practice.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Technology-enhanced Teleconsultation, Standard Teleconsultation
- Keywords
- Cognitive Processing Therapy, Consultation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-enhanced TeleconsultationOther
Technology-enhanced Group Tele-consultation. This consultation method requires that participants be prepared to review and receive feedback on audiorecorded CPT sessions in a group format. The CPT expert randomly selects two clinician sessions each week that have been audiorecorded to use for feedback and discussion in group teleconference based on procedures used in previous training initiatives (Stirman, Bhar, et al., 2010). Five- to twenty-minute segments of the two sessions will be shared within the group consultation. The CPT expert will provide feedback on the sessions with an emphasis on review of key learning points. These consultation group sessions will be facilitated with collaborative meeting software that includes audio file uploading.
Standard TeleconsultationOther
Standard Tele-consultation Group. The CPT expert will randomly select clinicians for case presentation each week. Each clinician will be responsible for verbally presenting on their CPT cases throughout the 6-month period of consultation course. No audiorecorded content will be reviewed within the calls. All other procedures used in the above condition will be used here.
| Study group | Role | What they receive |
|---|---|---|
| Technology-enhanced Teleconsultation | Experimental | Technology-enhanced Group Tele-consultation. This consultation method requires that participants be prepared to review and receive feedback on audiorecorded CPT sessions in a group format. The CPT expert randomly selects two clinician sessions each week that have been audiorecorded to use for feedback and discussion in group teleconference based on procedures used in previous training initiatives (Stirman, Bhar, et al., 2010). Five- to twenty-minute segments of the two sessions will be shared within the group consultation. The CPT expert will provide feedback on the sessions with an emphasis on review of key learning points. These consultation group sessions will be facilitated with collaborative meeting software that includes audio file uploading. Receives: Other: Technology-enhanced Teleconsultation |
| Standard Teleconsultation | Experimental | Standard Tele-consultation Group. The CPT expert will randomly select clinicians for case presentation each week. Each clinician will be responsible for verbally presenting on their CPT cases throughout the 6-month period of consultation course. No audiorecorded content will be reviewed within the calls. All other procedures used in the above condition will be used here. Receives: Other: Standard Teleconsultation |
| No consultation | No intervention | No Consultation/Fidelity Monitoring Only. Participants assigned to this condition will receive no post-workshop expert consultation, but will be subject to the same audiorecorded session-uploading and client-outcome reporting as the other conditions. This condition allows us to assess the effect of clinicians knowing that their sessions are subject to fidelity assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Processing Therapy Fidelity Ratings
Cognitive Processing Therapy (CPT) sessions will be rated by trained CPT Fidelity raters for fidelity to the CPT protocol.
Measured: Clinician-participants' CPT session audio tapes from the 6 month study period will be assessed at the 6 month time point.
Secondary outcomes (3)
PTSD Checklist (PCL-S)
The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD.
Measured: At baseline, approximately once per week for approximately 12 weeks, and once at 3 month follow up
SF-12 Health Survey
An even shorter - 1-page, 2-minute - survey form has been shown to yield summary physical and mental health outcome scores that are interchangeable with those from the SF-36® in both general and specific populations. This short-form - the SF-12® - which was published in early 1995 is already one of the most widely used surveys.
Measured: At baseline, approximately once every 2 weeks for approximately 12 weeks, and once at 3 month follow up
Outcomes Questionnaire 45 (OQ-45)
The OQ®-45.2 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time.
Measured: At baseline, approximately once per week for 12 weeks, and once at 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startFeb 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Candice Monson, Toronto Metropolitan University
- Investigators
- Candice Monson, Ph D, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861769
- Sponsor's protocol ID
- CIHR 2011-03-01
- Status last verified
- Nov 2014
- First submitted
- 15 May 2013
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wiltsey Stirman S, Shields N, Deloriea J, Landy MS, Belus JM, Maslej MM, Monson CM. A randomized controlled dismantling trial of post-workshop consultation strategies to increase effectiveness and fidelity to an evidence-based psychotherapy for Posttraumatic Stress Disorder. Implement Sci. 2013 Aug 1;8:82. doi: 10.1186/1748-5908-8-82.
PubMed 23902798
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Evidence-based Psychotherapy for PTSD: An Empirical Investigation of Post-workshop Consultation in Treatment Fidelity and Patient Outcomes
- ClinicalTrials.gov ID
- NCT01861769
- Acronym / sponsor ID
- CIHR 2011-03-01
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Cognitive Processing Therapy, Consultation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Feb 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 9% of Canadians will have Posttraumatic Stress Disorder (PTSD) in their lifetime. In the military veteran population, the lifetime prevalence of PTSD has been estimated to be as high as 20%. Numerous research studies have demonstrated that short-term, cognitive-behavioral psychotherapies, such as Cognitive Processing Therapy (CPT), lead to substantial improvements in PTSD symptoms. However, research suggests that a minority of clinicians provide these therapies in clinical settings. The transfer of this research knowledge into clinical settings remains one of the largest hurdles to improving the health of Canadians with PTSD.
It is well established that attending a 2-day workshop on these therapies alone is insufficient to promote adequate knowledge transfer and sustained skillful use. The current study aims to contrast whether two forms of post-workshop support (6-month duration), with different levels of expert oversight, will result in superior levels of clinician skill and patient outcomes versus no formal post-workshop support. The three forms of post-workshop support are 1) technology-enhanced group tele-consultation 2) standard group tele-consultation 3) no tele consultation. The primary and secondary outcomes will be the assessment of the clinicians' competence in CPT and patient symptoms,respectively. This study will inform how best to transfer evidence based therapy outcomes to the clinical milieu to attain comparable outcomes as those observed in research.
The investigators' hypotheses are as follows: Hypothesis 1:The technology enhanced group tele-consultation condition will evidence the highest levels of fidelity, the standard group tele-consultation condition will evidence intermediate levels of fidelity, and the no-consultation/fidelity monitoring only condition will evidence the lowest fidelity. Hypothesis 2: Fidelity to the CPT protocol, irrespective of consultation condition, will be positively associated with improved client outcomes. Hypothesis 3: Organizational context variables, such as the organizational climate and readiness for change, will influence the uptake of CPT skills, as well as the extent to which these skills are utilized in practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Technology-enhanced Teleconsultation | Experimental | Other: Technology-enhanced TeleconsultationTechnology-enhanced Group Tele-consultation. This consultation method requires that participants be prepared to review and receive feedback on audiorecorded CPT sessions in a group format. The CPT expert randomly selects two clinician sessions each week that have been audiorecorded to use for feedback and discussion in group teleconference based on procedures used in previous training initiatives (Stirman, Bhar, et al., 2010). Five- to twenty-minute segments of the two sessions will be shared within the group consultation. The CPT expert will provide feedback on the sessions with an emphasis on review of key learning points. These consultation group sessions will be facilitated with collaborative meeting software that includes audio file uploading. |
| Standard Teleconsultation | Experimental | Other: Standard TeleconsultationStandard Tele-consultation Group. The CPT expert will randomly select clinicians for case presentation each week. Each clinician will be responsible for verbally presenting on their CPT cases throughout the 6-month period of consultation course. No audiorecorded content will be reviewed within the calls. All other procedures used in the above condition will be used here. |
| No consultation | No intervention | –No Consultation/Fidelity Monitoring Only. Participants assigned to this condition will receive no post-workshop expert consultation, but will be subject to the same audiorecorded session-uploading and client-outcome reporting as the other conditions. This condition allows us to assess the effect of clinicians knowing that their sessions are subject to fidelity assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Clinician participants (n=120) recruited for this study will either be Operation Stress Injury (OSI) network clinicians, Operational Trauma and Stress Support Centre (OTSSC) network clinicians or community-based clinicians who treat military-related PTSD.
- Both male and female clinician participants will be recruited;
- Clinician participants will be greater than 18 years.
- Mental health clinicians from the clinics and private practitioners will be eligible to participate in the study if they:
- attend the CPT workshop;
Key exclusion criteria (5 listed)
- Ineligible patients will include those not eligible for CPT based on the state of research evidence, including those with:
- current uncontrolled psychotic or bipolar disorder;
- unremitted substance dependence diagnosis (substance abuse allowed);
- current imminent suicidality or homicidality that requires imminent attention; and
- significant cognitive impairment.
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 |
|---|---|---|
| Technology-enhanced TeleconsultationTechnology-enhanced Group Tele-consultation. This consultation method requires that participants be prepared to review and receive feedback on audiorecorded CPT sessions in a group format. The CPT expert randomly selects two clinician sessions each week that have been audiorecorded to use for feedback and discussion in group teleconference based on procedures used in previous training initiatives (Stirman, Bhar, et al., 2010). Five- to twenty-minute segments of the two sessions will be shared within the group consultation. The CPT expert will provide feedback on the sessions with an emphasis on review of key learning points. These consultation group sessions will be facilitated with collaborative meeting software that includes audio file uploading. | Other | Technology-enhanced Teleconsultation |
| Standard TeleconsultationStandard Tele-consultation Group. The CPT expert will randomly select clinicians for case presentation each week. Each clinician will be responsible for verbally presenting on their CPT cases throughout the 6-month period of consultation course. No audiorecorded content will be reviewed within the calls. All other procedures used in the above condition will be used here. | Other | Standard Teleconsultation |
Primary outcome
Cognitive Processing Therapy Fidelity Ratings
Time frame: Clinician-participants' CPT session audio tapes from the 6 month study period will be assessed at the 6 month time point.
Cognitive Processing Therapy (CPT) sessions will be rated by trained CPT Fidelity raters for fidelity to the CPT protocol.
3 secondary outcomes
PTSD Checklist (PCL-S)
Time frame: At baseline, approximately once per week for approximately 12 weeks, and once at 3 month follow up
SF-12 Health Survey
Time frame: At baseline, approximately once every 2 weeks for approximately 12 weeks, and once at 3 month follow up
Outcomes Questionnaire 45 (OQ-45)
Time frame: At baseline, approximately once per week for 12 weeks, and once at 3 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
- Derived from this study: PubMed 23902798Wiltsey Stirman S, Shields N, Deloriea J, Landy MS, Belus JM, Maslej MM, Monson CM. A randomized controlled dismantling trial of post-workshop consultation strategies to increase effectiveness and fidelity to an evidence-based psychotherapy for Posttraumatic Stress Disorder. Implement Sci. 2013 Aug 1;8:82. doi: 10.1186/1748-5908-8-82.
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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.
Candice Monson, Ph D principal investigator
Toronto Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-enhanced Teleconsultation and Standard Teleconsultation in people with Posttraumatic Stress Disorder, run by Toronto Metropolitan University at 1 site in Canada.
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 12 inclusion and 5 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 4 Nov 2014. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive Processing Therapy Fidelity Ratings (time frame: Clinician-participants' CPT session audio tapes from the 6 month study period will be assessed at the 6 month time point.). 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 NCT01861769, 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 4 Nov 2014.