Patient Engagement in PTSD Treatment (PEP) - Advancing PTSD Treatment Outcomes

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults (18 years or older)

• PTSD pursuant to the ICD-10 research criteria

• Signed informed consent

• patients referred to Main Level treatment

• 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

Locations
Other Locations
Denmark
Mental Health Centre Ballerup
RECRUITING
Ballerup Municipality
Contact Information
Primary
Anna Bolette L. Nielsen, Medical Doctor
anna.bolette.lund.nielsen.03@regionh.dk
+4538646181
Backup
Laura E. Fonnesbaek, Authorised psychologist
laura.eybye.fonnesbaek@regionh.dk
+4538645010
Time Frame
Start Date: 2025-01-02
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 427
Treatments
Active_comparator: Treatment as usual (TAU)
8-12 months of treatment Interventions: Behavioral: treamtent as usuan (TAU)
Experimental: Introductory PTSD module + TAU
9-13 months of treatment An intervention with an introductory PTSD module consistent of four sessions focusing on motivation followed by TAU
Experimental: Introductory PTSD module + one session of Shared Decision Making + individualised treatment
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.
Related Therapeutic Areas
Sponsors
Leads: Mental Health Services in the Capital Region, Denmark

This content was sourced from clinicaltrials.gov