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Implementation of Evidence-based Psychotherapy for PTSD

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Technology-enhanced Teleconsultation
Standard Teleconsultation
Sponsored by
Toronto Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Cognitive Processing Therapy, Consultation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

  1. attend the CPT workshop;
  2. are employees of an OSI or OTSSC clinic, are registered VAC clinicians, or are in private practice treating individuals with military-related PTSD;
  3. currently provide psychotherapy to military soldiers or veterans with PTSD;
  4. consent to be randomized to one of the three study conditions; and,
  5. are willing to solicit patient participation.

Eligible patient participants are:

  1. 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
  2. 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.

Exclusion Criteria:

Ineligible patients will include those not eligible for CPT based on the state of research evidence, including those with:

  1. current uncontrolled psychotic or bipolar disorder;
  2. unremitted substance dependence diagnosis (substance abuse allowed);
  3. current imminent suicidality or homicidality that requires imminent attention; and
  4. significant cognitive impairment.

Sites / Locations

  • Edmonton Operational Stress Injury Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Technology-enhanced Teleconsultation

Standard Teleconsultation

No consultation

Arm Description

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 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/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.

Outcomes

Primary Outcome Measures

Cognitive Processing Therapy Fidelity Ratings
Cognitive Processing Therapy (CPT) sessions will be rated by trained CPT Fidelity raters for fidelity to the CPT protocol.

Secondary Outcome Measures

PTSD Checklist (PCL-S)
The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD.
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.
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.

Full Information

First Posted
May 15, 2013
Last Updated
November 3, 2014
Sponsor
Toronto Metropolitan University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01861769
Brief Title
Implementation of Evidence-based Psychotherapy for PTSD
Official Title
Implementation of Evidence-based Psychotherapy for PTSD: An Empirical Investigation of Post-workshop Consultation in Treatment Fidelity and Patient Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Metropolitan University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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%. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Cognitive Processing Therapy, Consultation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Technology-enhanced Teleconsultation
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Teleconsultation
Arm Type
Experimental
Arm Description
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.
Arm Title
No consultation
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Technology-enhanced Teleconsultation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Teleconsultation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive Processing Therapy Fidelity Ratings
Description
Cognitive Processing Therapy (CPT) sessions will be rated by trained CPT Fidelity raters for fidelity to the CPT protocol.
Time Frame
Clinician-participants' CPT session audio tapes from the 6 month study period will be assessed at the 6 month time point.
Secondary Outcome Measure Information:
Title
PTSD Checklist (PCL-S)
Description
The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD.
Time Frame
At baseline, approximately once per week for approximately 12 weeks, and once at 3 month follow up
Title
SF-12 Health Survey
Description
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.
Time Frame
At baseline, approximately once every 2 weeks for approximately 12 weeks, and once at 3 month follow up
Title
Outcomes Questionnaire 45 (OQ-45)
Description
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.
Time Frame
At baseline, approximately once per week for 12 weeks, and once at 3 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candice Monson, Ph D
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edmonton Operational Stress Injury Clinic
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5E 5R8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23902798
Citation
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.
Results Reference
derived

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Implementation of Evidence-based Psychotherapy for PTSD

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