Stress Disorders, Post-TraumaticNCT01702168
Implementation of CPT for PTSD in Diverse Communities
An observational study of Stress Disorders, Post-Traumatic, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Aim: To identify, assess, and address organizational context and provider-level barriers and facilitators of implementation of Evidence-based treatments (EBTs) using a mixed-methods approach in a diverse community mental health center (CMHC), Massachusetts General Hospital Chelsea Health Clinic (MGH Chelsea). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Provider training: Cognitive Processing Therapy (CPT)
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2016
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will be working with community mental health workers and stakeholders at a community clinic, MGH Chelsea.
Who may be able to join
- Be over 18 years of age
- Speak English
- Be employed at least part time at MGH
- Willing to have focus group/interview audiotaped and transcribed for data analysis
Who cannot join
- inability to meet the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Chelsea Health Center
Chelsea, Massachusetts, 02114
About this study
Official title: Implementation of Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD) in Diverse Communities
Aim: To identify, assess, and address organizational context and provider-level barriers and facilitators of implementation of Evidence-based treatments (EBTs) using a mixed-methods approach in a diverse community mental health center (CMHC), Massachusetts General Hospital Chelsea Health Clinic (MGH Chelsea).
Hypothesis: Anticipated barriers may include, but are not limited to, organizational climate, heavy case-loads, community mental health workers (CMHW) beliefs about EBTs, and provider motivation to learn EBT.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Provider training: Cognitive Processing Therapy (CPT)
- Keywords
- PTSD, EBT, EST, Community, Latino
- 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.
Provider training: Cognitive Processing Therapy (CPT)Other
| Study group | Role | What they receive |
|---|---|---|
| CBT Training | Not described Receives: Other: Provider training: Cognitive Processing Therapy (CPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EBPAS-50
Evidence Based Practice Attitudes Scale (EBPAS-50) is a brief, validated measure of clinician attitudes towards evidence based treatments (EBTs) containing four subscales: 1) Appeal measures whether the provider would adopt a new practice if it is intuitively appealing, or is being used by colleagues who are happy with it; 2)Requirement measures whether provider would adopt a practice if it is required by an agency, supervisor, or state; 3)Openness measures whether the provider is generally open to trying new interventions and would be willing to try or use new types of therapy, and 4)Divergence measures whether the provider perceives research-based interventions as not clinically useful or less important than clinical experience.
Measured: up to 5 years
ORC
Organizational Readiness for Change (ORC) measures organizational climate. The ORC is defined as the organizational and staff factors related to adoption of new technologies. ORC is conceptualized as a set of factors that are necessary for sustained change. These factors include motivation, resources, staff attributes, and organizational climate. Readiness for change has been associated with successful dissemination.
Measured: up to 5 years
OSC
The Organizational Social Context (OSC) measures the following domains: structure, culture, psychological and organizational climate, and work attitudes. The OSC measurement system is a validated measure guided by a model of social context that composes both organizational(structure and culture) and individual (work attitudes and behavior) level constructs, including individual and shared perceptions (psychological and organizational climate) that are believed to mediate the impact of the organization on the individual. The OSC measurement system includes 105 items that form 16 first order factors and seven second order factors confirmed in national samples of social and mental health service organizations. These factors are grouped by the domains of structure, culture, psychological and organizational climate, and work attitudes.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Luana Marques, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702168
- Sponsor's protocol ID
- 1K23MH096029-01A1
- Status last verified
- Mar 2019
- First submitted
- 3 Oct 2012
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD) in Diverse Communities
- ClinicalTrials.gov ID
- NCT01702168
- Acronym / sponsor ID
- 1K23MH096029-01A1
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- PTSD, EBT, EST, Community, Latino
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 Oct 2012 (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.
Aim: To identify, assess, and address organizational context and provider-level barriers and facilitators of implementation of Evidence-based treatments (EBTs) using a mixed-methods approach in a diverse community mental health center (CMHC), Massachusetts General Hospital Chelsea Health Clinic (MGH Chelsea).
Hypothesis: Anticipated barriers may include, but are not limited to, organizational climate, heavy case-loads, community mental health workers (CMHW) beliefs about EBTs, and provider motivation to learn EBT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT Training | – | Other: Provider training: Cognitive Processing Therapy (CPT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will be working with community mental health workers and stakeholders at a community clinic, MGH Chelsea.
Key inclusion criteria (4 listed)
- Be over 18 years of age
- Speak English
- Be employed at least part time at MGH
- Willing to have focus group/interview audiotaped and transcribed for data analysis
Key exclusion criteria (1 listed)
- inability to meet the above inclusion criteria
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 |
|---|---|---|
| Provider training: Cognitive Processing Therapy (CPT) | Other | CBT Training |
Primary outcome
EBPAS-50
Time frame: up to 5 years
Evidence Based Practice Attitudes Scale (EBPAS-50) is a brief, validated measure of clinician attitudes towards evidence based treatments (EBTs) containing four subscales: 1) Appeal measures whether the provider would adopt a new practice if it is intuitively appealing, or is being used by colleagues who are happy with it; 2)Requirement measures whether provider would adopt a practice if it is required by an agency, supervisor, or state; 3)Openness measures whether the provider is generally open to trying new interventions and would be willing to try or use new types of therapy, and 4)Divergence measures whether the provider perceives research-based interventions as not clinically useful or less important than clinical experience.
ORC
Time frame: up to 5 years
Organizational Readiness for Change (ORC) measures organizational climate. The ORC is defined as the organizational and staff factors related to adoption of new technologies. ORC is conceptualized as a set of factors that are necessary for sustained change. These factors include motivation, resources, staff attributes, and organizational climate. Readiness for change has been associated with successful dissemination.
OSC
Time frame: up to 5 years
The Organizational Social Context (OSC) measures the following domains: structure, culture, psychological and organizational climate, and work attitudes. The OSC measurement system is a validated measure guided by a model of social context that composes both organizational(structure and culture) and individual (work attitudes and behavior) level constructs, including individual and shared perceptions (psychological and organizational climate) that are believed to mediate the impact of the organization on the individual. The OSC measurement system includes 105 items that form 16 first order factors and seven second order factors confirmed in national samples of social and mental health service organizations. These factors are grouped by the domains of structure, culture, psychological and organizational climate, and work attitudes.
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 8 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorders, Post-Traumatic, run by Massachusetts General Hospital 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 8 Mar 2019. 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. 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?
EBPAS-50 (time frame: up to 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2019.