Patient Engagement in PTSD Treatment (PEP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHerlev and Gentofte Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Adults (18 years or older)
PTSD pursuant to the ICD-10 research criteria
Signed informed consent
patients referred to "Main Level" treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Introductory PTSD module
BehavioralThe Introductory PTSD module consist of four session focusing on motivation
Shared Decision Making
BehavioralA patient-centred shared decision making session where one of four standardised treatments can be chosen
Treatment as Usual
BehavioralTreatment as usual
Standardised treatments
BehavioralOne of four treatments Treatment as ususal Sessions with psychologists Sessions with nurses Sessions with medical doctors
Treatment groups
427 Participants
are divided into 3 treatment groupsGroup A: Treatment as usual (TAU)Active comparator 1 intervention
Group B: Introductory PTSD module + TAUExperimental treatment 2 interventions
Group C: Introductory PTSD module + one session of Shared Decision Making + individualised treatmentExperimental treatment 3 interventions
Trial outcomes
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
Time frame
Change from baseline to end-of-treatment after approximately 10 monthsSecondary outcomes
1
Readiness of Psychotherapy Index (RPI)
RPI is used to assess an individual's readiness to engage in and benefit from psychotherapy. It evaluates motivation, perceived need for treatment, and confidence in the therapeutic process, helping clinicians gauge how prepared and willing a person is to start and actively participate in therapy. Scoring range: 1-5, in item 1, 2, 12, 13 and 17 a higher scores reflect lower degree of readiness, in item 3, 4, 5, 6, 7, 8, 9, 10, 11, 14, 15, 16, 18, 19 og 20 a higher score reflects a higher degree of readiness
Time frame
Change from baseline to after intervention after approximately 1,5 months2
Hopkins Symptom Check List-25 (HSCL)
HSCL-25 is an internationally applied and thoroughly validated self-administered rating scale assessing the severity of anxiety and depression symptoms. This is a short version of the Symptom Checklist-90 (SCL-90). It consists of 25 questions, 10 regarding anxiety and 15 regarding depression. Scoring range: 1-4, lower scores reflect better outcome
Time frame
Change from baseline to end-of-treatment after approximately 10 months3
Psychological Outcome Profiles questionnaire (PSYCHLOPS)
It is a self-report measure designed to assess patient-generated outcomes measuring three domains: Problems, Function and Wellbeing. There is a pre-treatment and a post-treatment version. Scoring range: 0-5, lower score reflect better outcome
Time frame
Change from baseline to end-of-treatment after approximately 10 months4
World Health Organisation - 5 Well-being Index (WHO-5)
It is a self-administered questionnaire evaluating quality of life, consisting of five questions with each six possible answers. The questionnaire has been used to assess the quality of life in several psychiatric diagnostic groups. In addition, the scale has been used to assess overall treatment effects in the field of psychiatry. Scoring range: 0-100, higher scores reflect better outcome.
Time frame
Change from baseline to end-of-treatment after approximately 10 monthsSponsors and contacts
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Source ClinicalTrials.gov