Patient Engagement in PTSD Treatment (PEP)

NCT06755710 | Recruiting

• 1 other identifier: H-24049563
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to improve the outcome of outpatient PTSD treatment at two clinics treating majority ethnic Danes and refugees with PTSD respectively. The study will consist of two similar randomized controlled trials. The main questions the study aims to answer are:

• Does an added motivation enhancement module as a precursor for PTSD treatment reduce dropout and increase treatment outcome?
• Does an added Shared Decision-Making session which facilitate individualized treatment yield a superior outcome compared to PTSD treatment and PTSD treatment supplemented by motivation enhancement? Participants are recruited at two different clinics, Psychotherapeutic Unit (PU) and Competence Centre for Transcultural Psychiatry (CTP). At PU the participants are randomized to one of two arms, and at CTP to one of three arms. One arm is the control group where participants will receive treatment as usual (TAU), one arm is the first intervention group where the participants will receive an Introductory PTSD module consisting of four sessions focusing on enhancing motivation for PTSD treatment, before continuing in TAU. The last arm is the second intervention group, which will only take place at CTP. Here the patient will receive the Introductory PTSD module followed by a session of Shared Decision Making, where the participant together with the MD decides which of four standardized treatment courses they will receive. The treatment for all patients will last between 8-13 months.

Conditions

PTSD; Depression Disorders; Patient Engagement

Outcome Measures

Primary Outcomes (1)

• International Trauma Questionnaire (ITQ)

  A brief, simply worded measure, focusing only on the core features of PTSD and CPTSD, and employs straightforward diagnostic rules, based on the International Classification of Diseases, 11th edition (ICD-11). Scoring range: 0-4, lower scores reflect better outcome

  Change from baseline to end-of-treatment after approximately 10 months

Secondary Outcomes (13)

• Readiness of Psychotherapy Index (RPI)

  Change from baseline to after intervention after approximately 1,5 months

• Hopkins Symptom Check List-25 (HSCL)

  Change from baseline to end-of-treatment after approximately 10 months

• Psychological Outcome Profiles questionnaire (PSYCHLOPS)

  Change from baseline to end-of-treatment after approximately 10 months

• World Health Organisation - 5 Well-being Index (WHO-5)

  Change from baseline to end-of-treatment after approximately 10 months

• Life Events Checklist for DSM-5 (LEC-5)

  Administered once at the initial assessment

Study Arms (3)

Treatment as usual (TAU)

ACTIVE COMPARATOR

8-12 months of treatment Interventions: Behavioral: treamtent as usuan (TAU)

Behavioral: Treatment as Usual

Introductory PTSD module + TAU

EXPERIMENTAL

9-13 months of treatment An intervention with an introductory PTSD module consistent of four sessions focusing on motivation followed by TAU

Behavioral: Introductory PTSD module; Behavioral: Treatment as Usual

Introductory PTSD module + one session of Shared Decision Making + individualised treatment

EXPERIMENTAL

9-13 months of treatment Add-on introductory PTSD module and add-on patient-centred shared decision making session before continuing in the chosen standardised treatment.

Behavioral: Introductory PTSD module; Behavioral: Shared Decision Making; Behavioral: Standardised treatments

Interventions

Introductory PTSD module BEHAVIORAL

The Introductory PTSD module consist of four session focusing on motivation

Introductory PTSD module + TAU; Introductory PTSD module + one session of Shared Decision Making + individualised treatment

Shared Decision Making BEHAVIORAL

A patient-centred shared decision making session where one of four standardised treatments can be chosen

Introductory PTSD module + one session of Shared Decision Making + individualised treatment

Treatment as Usual BEHAVIORAL

Treatment as usual

Introductory PTSD module + TAU; Treatment as usual (TAU)

Standardised treatments BEHAVIORAL

One of four treatments Treatment as ususal Sessions with psychologists Sessions with nurses Sessions with medical doctors

Introductory PTSD module + one session of Shared Decision Making + individualised treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Adults (18 years or older)
• PTSD pursuant to the ICD-10 research criteria
• Signed informed consent
• patients referred to "Main Level" treatment
• Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Participants are excluded only if the psychotic experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and/or depression.
• Dependence syndrome of drugs or alcohol: Active dependence and use (F1x.24-F1x.26).
• Adult (18 years or older)
• Refugees or persons who have been family reunified with a refugee
• PTSD pursuant to the ICD-10 research criteria
• Psychological trauma experienced outside Denmark in the anamnesis. Trauma is imprisonment or detention with torture (according to the United Nations' definition of torture) or acts of cruel, inhuman and degrading treatment or punishment. Trauma can also be organised violence, long-term political persecution and harassment, or war and civil war experiences.
• Signed informed consent
• Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Participants are excluded only if the psychotic experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and/or depression.
• Dependence syndrome of drugs or alcohol: Active dependence and use (F1x.24-F1x.26).

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead

Study Sites (1)

Mental Health Centre Ballerup

Ballerup Municipality, Capital Region, 2750, Denmark

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Patient Participation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jessica Carlsson

  Mental Health Services in th Capital Region, Denmark

  STUDY CHAIR

Central Study Contacts

Anna Bolette L. Nielsen, Medical Doctor

CONTACT

+4538646181; anna.bolette.lund.nielsen.03@regionh.dk

Laura E. Fonnesbaek, Authorised psychologist

CONTACT

+4538645010; laura.eybye.fonnesbaek@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: January 1, 2025
• Study Start: January 2, 2025
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)