NCT04735328

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 adult specialized mental health services. Specifically, the project will examine the 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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

February 3, 2021

Status Verified

January 1, 2021

Enrollment Period

2.4 years

First QC Date

January 28, 2021

Last Update Submit

January 28, 2021

Conditions

Post-traumatic Stress DisorderLeadershipImplementation

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 evidencebased practice (EBP) implementation.Scored from 0 (not at all) to 4 (to a very great extent).

    4 weeks

Secondary Outcomes (9)

  • Number of trauma assessments and patients that receive trauma treatment

    12 months

  • The Multifactor Leadership Questionnaire (MLQ)

    12 months

  • The Implementation Climate (IC)

    12 months

  • Workload (QPS)

    12 months

  • The Implementation Citizenship Behavior Scale (ICBS)

    12 months

  • +4 more secondary outcomes

Study Arms (1)

Intervention

OTHER

When clinics join the intervention, 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 and CT-PTSD).

Behavioral: LOCIBehavioral: CT-PTSDBehavioral: EMDR

Interventions

LOCIBEHAVIORAL

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

Intervention
CT-PTSDBEHAVIORAL

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

Intervention
EMDRBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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)

Norwegian Center for Violence and Traumatic Stress Studies (NKVTS)

Oslo, 0408, Norway

RECRUITING

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

Central Study Contacts

Karina Egeland, PHD

CONTACT

+4790602326karina.egeland@nkvts.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Participating clinics will be grouped in four groups - two groups will start the intervention in 2021, two groups will start in 2022. All participants receive the same intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 3, 2021

Study Start

April 1, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

February 3, 2021

Record last verified: 2021-01

Locations

NO(1)