NCT03719651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 8, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

July 5, 2018

Last Update Submit

March 5, 2021

Conditions

Post-traumatic Stress DisorderLeadership

Keywords

ImplementationImplementation strategyLeadershipOrganizational climateFidelityPTSD treatment

Outcome Measures

Primary Outcomes (1)

  • Implementation Leadership Scale (ILS)

    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).

    4 weeks

Secondary Outcomes (12)

  • Number of trauma assessments and patients that receive trauma treatment.

    12 months

  • The Multifactor Leadership Questionnaire (MLQ)

    12 months

  • The Implementation Climate Scale (ICS)

    12 months

  • The Implementation Climate (IC)

    12 months

  • Workload (QPS)

    12 months

  • +7 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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: LOCIBehavioral: EMDRBehavioral: CT-PTSDBehavioral: TF-CBT

Control

ACTIVE COMPARATOR

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: EMDRBehavioral: CT-PTSDBehavioral: TF-CBT

Interventions

LOCIBEHAVIORAL

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

Intervention
EMDRBEHAVIORAL

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

ControlIntervention
CT-PTSDBEHAVIORAL

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

ControlIntervention
TF-CBTBEHAVIORAL

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

ControlIntervention

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karina Egeland

Oslo, 0484, Norway

Location

Related Publications (4)

  • Egeland KM, Borge RH, Peters N, Baekkelund H, Braathu N, Sklar M, Aarons GA, Skar AS. Individual-level associations between implementation leadership, climate, and anticipated outcomes: a time-lagged mediation analysis. Implement Sci Commun. 2023 Jul 11;4(1):75. doi: 10.1186/s43058-023-00459-7.

    PMID: 37434244DERIVED

  • Skar AS, Braathu N, Peters N, Baekkelund H, Endsjo M, Babaii A, Borge RH, Wentzel-Larsen T, Ehrhart MG, Sklar M, Brown CH, Aarons GA, Egeland KM. A stepped-wedge randomized trial investigating the effect of the Leadership and Organizational Change for Implementation (LOCI) intervention on implementation and transformational leadership, and implementation climate. BMC Health Serv Res. 2022 Mar 4;22(1):298. doi: 10.1186/s12913-022-07539-9.

    PMID: 35246135DERIVED

  • Borge RH, Skar AS, Endsjo M, Egeland KM. Good soldiers in implementation: validation of the Implementation Citizenship Behavior Scale and its relation to implementation leadership and intentions to use evidence-based practices. Implement Sci Commun. 2021 Dec 11;2(1):136. doi: 10.1186/s43058-021-00240-8.

    PMID: 34895347DERIVED

  • Egeland KM, Skar AS, Endsjo M, Laukvik EH, Baekkelund H, Babaii A, Granly LB, Husebo GK, Borge RH, Ehrhart MG, Sklar M, Brown CH, Aarons GA. Testing the leadership and organizational change for implementation (LOCI) intervention in Norwegian mental health clinics: a stepped-wedge cluster randomized design study protocol. Implement Sci. 2019 Mar 13;14(1):28. doi: 10.1186/s13012-019-0873-7.

    PMID: 30866973DERIVED

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Karina M Egeland, PhD

    Norwegian Centre for Violence and Traumatic Stress Studies (NKVTS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Stepped wedge design with three cohorts
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

July 5, 2018

First Posted

October 25, 2018

Study Start

January 15, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 8, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)