Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Testing the LOCI Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03719651
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Karina Ester Myhren Egeland, Norwegian Center for Violence and Traumatic Stress Studies

Brief Summary:

The project will develop knowledge on how managers can lead the implementation of practices that have proven to be effective for post-traumatic stress disorders (PTSD) in child and adult specialized mental health services. Specifically, the project will test the effectiveness of an intervention named the Leadership and Organizational Change for Implementation (LOCI). This is an empirically and theoretically based innovation for implementation leadership that aims to support leaders in their organizational work of leading the implementation of EBPs in their clinics.

It is hypothesized that the implementation of LOCI will improve leaders' general leadership qualifications, their implementation leadership qualifications, and the implementation climate in the clinics. Further, the investigators hypothesize that training in trauma screening will increase the amount of trauma screenings, moderated by the LOCI implementation, and also that training in trauma treatment will increase the amount of patients to be offered this kind of treatment, also moderated by the LOCI implementation.


Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Leadership Behavioral: LOCI Behavioral: EMDR Behavioral: CT-PTSD Behavioral: TF-CBT Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stepped wedge design with three cohorts
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention in Norwegian Mental Health Clinics: A Stepped-wedge Design Study Protocol
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: Intervention

When clinics join the intervention arm, leaders will receive leadership training through the Leadership and Organizational Change for Implementation (LOCI) intervention.

Therapists will receive training in evidence-based practices for treatment of Post-Traumatic Stress Symptoms (EMDR, CT-PTSD, TF-CBT)

Behavioral: LOCI
LOCI includes training of leaders in general leadership, implementation leadership, and implementation climate.

Behavioral: EMDR
EMDR (Eye Movement and Desensitization Reprocessing), treatment method developed for treating patients with Post-Traumatic Stress Symptoms (PTSD).

Behavioral: CT-PTSD
CT-PTSD (Cognitive Therapy for PTSD), treatment method developed for treating patients with Post-Traumatic Stress Symptoms (PTSD).

Behavioral: TF-CBT
TF-CBT (Trauma-Focused Cognitive-Behavioral Treatment) treatment method developed for treating patients with Post-Traumatic Stress Symptoms (PTSD).

Active Comparator: Control

Clinics that are not yet included in the intervention arm, the leaders will not receive any leadership training (LOCI).

Therapists will receive training in evidence-based practices for treatment of Post-Traumatic Stress Symptoms (EMDR, CT-PTSD, TF-CBT)

Behavioral: EMDR
EMDR (Eye Movement and Desensitization Reprocessing), treatment method developed for treating patients with Post-Traumatic Stress Symptoms (PTSD).

Behavioral: CT-PTSD
CT-PTSD (Cognitive Therapy for PTSD), treatment method developed for treating patients with Post-Traumatic Stress Symptoms (PTSD).

Behavioral: TF-CBT
TF-CBT (Trauma-Focused Cognitive-Behavioral Treatment) treatment method developed for treating patients with Post-Traumatic Stress Symptoms (PTSD).




Primary Outcome Measures :
  1. Implementation Leadership Scale (ILS) [ Time Frame: 4 weeks ]
    ILS assesses the degree to which leaders are knowledgeable, proactive, perseverant, and supportive during evidence-based practice (EBP) implementation.Scored from 0 (not at all) to 4 (to a very great extent).


Secondary Outcome Measures :
  1. Number of trauma assessments and patients that receive trauma treatment. [ Time Frame: 12 months ]
    Practitioners are asked to report the number of trauma assessments done within the last 4 months. The practitioners that have been trained in either TF-CBT, EMDR or CT-PTSD will also be asked to report the number of patients that receive the specific treatment.

  2. The Multifactor Leadership Questionnaire (MLQ) [ Time Frame: 12 months ]
    A 36-item measure addressing transformational and transactional leadership. Scored from 0 (not at all) to 4 (frequently, if not always)

  3. The Implementation Climate Scale (ICS) [ Time Frame: 12 months ]
    An 18-item measure addressing to what extent an organization support the implementation of EBP. Scored from 0 (not at all) to 4 (to a very great extent).

  4. The Implementation Climate (IC) [ Time Frame: 12 months ]
    A 6-item measure addressing the implementation climate in the organization. Scored from 0 (not at all) to 4 (often, if not always).

  5. Workload (QPS) [ Time Frame: 12 months ]
    Thirteen items from the QPS Nordic questionnaire. Coping with work (6 items), job demands (7 items). Scored from 1 (very seldom or never) to 5 (very often or always).

  6. The Implementation Citizenship Behavior Scale (ICBS) [ Time Frame: 12 months ]
    A six-item measure addressing employee behaviour that goes beyond their duty to support the implementation of EBP. Scored from 0 (Not at all) to 4 (Frequently, if not always).

  7. TF-CBT Fidelity [ Time Frame: 12 months ]
    Evaluating whether the therapist carries out the manual correctly. Developed for this Project.

  8. The Treatment integrity checklist for EMDR (T-TIP EMDR) [ Time Frame: 12 months ]
    consists of 16 items evaluating whether the therapist carries out the manual correctly ("yes" or "not relevant" = 1 point, "no" = 0 point). Maximal score is 16 points.

  9. Cognitive Therapy for Post-Traumatic Stress Disorder: A Checklist of Therapist Competency [ Time Frame: 12 months ]
    consists of 16 items evaluating therapists' general and specific therapeutic skills on a range between 0 (poor) and 6 (excellent)

  10. The Child & Adolescent Trauma Screening Questionnaire (CATS) [ Time Frame: 12 months ]
    20 symptom items and 5 functional impairment items. A total symptom severity scale score ranging from 0 to 60 is calculated. Screening cut off point is 15.

  11. Stressful Life Events Screening Questionnaire - revised (SLESQ) [ Time Frame: 12 months ]
    15 questions on stressful life events (0 = no, 1 = yes)

  12. PTSD Checklist (PCL-5) [ Time Frame: 12 months ]
    20 symptom items. A total symptom severity scale score ranging from 0 to 80. (0 = not at all, 4 = a lot)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Voluntary child and adult specialized mental health clinics that agree to the terms and conditions of the project, that is training, recruitment of patients, and data collection.
  • Patients with PTSD symptoms and that agree to participate in the project.

Exclusion Criteria:

  • Clinics or patients that do not agree to the terms and the conditions of the project

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719651


Contacts
Layout table for location contacts
Contact: Karina M. Egeland, PhD +47 90 60 23 26 karina.egeland@nkvts.no
Contact: Ane-Marthe Solheim Skar, PhD a.m.s.skar@nkvts.no

Locations
Layout table for location information
Norway
Karina Egeland Recruiting
Oslo, Norway, 0484
Contact: Karina M Egeland, PhD    +4790602326    karina.egeland@nkvts.no   
Contact: Ane-Marthe Solheim Skar, PhD       a.m.s.skar@psykologi.uio.no   
Sponsors and Collaborators
Norwegian Center for Violence and Traumatic Stress Studies
Investigators
Layout table for investigator information
Principal Investigator: Karina M Egeland, PhD Norwegian Centre for Violence and Traumatic Stress Studies (NKVTS)

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Karina Ester Myhren Egeland, Primary Investigator, Norwegian Center for Violence and Traumatic Stress Studies
ClinicalTrials.gov Identifier: NCT03719651     History of Changes
Other Study ID Numbers: LOCI Norway
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karina Ester Myhren Egeland, Norwegian Center for Violence and Traumatic Stress Studies:
Implementation
Implementation strategy
Leadership
Organizational climate
Fidelity
PTSD treatment

Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders