Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04244864 |
| Other study ID # |
PTF6 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 3, 2020 |
| Est. completion date |
September 2025 |
Study information
| Verified date |
August 2023 |
| Source |
Mental Health Services in the Capital Region, Denmark |
| Contact |
Maja Bruhn |
| Phone |
+4538646180 |
| Email |
maja.bruhn.kristiansen.03[@]regionh.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
INTRODUCTION Trauma-affected refugees are at high risk of developing mental health problems
including post-traumatic stress disorder (PTSD) and depression. In addition to traumatic
stress, refugees are furthermore subject to a range of post-migration stressors e.g.
unemployment, poor finances and language difficulties. These stressors can moderate or
exacerbate mental health outcomes in refugees.
Cross-sectoral collaboration and coordination of municipal social interventions and regional
mental health services are currently limited.
The overall aim of this study is to investigate the effect of a psychosocial treatment with a
focus on social stressors in an integrated cross-sectoral collaboration with the municipality
for trauma-affected refugees
MATERIALS AND METHODS The study is being conducted at Competence Centre for Transcultural
Psychiatry (CTP) in Denmark. Included in the study are refugees with post-traumatic stress
disorder (PTSD), who are unemployed and attending a municipal job centre in one of the five
collaborating municipalities. Approximately 200 patients will be included. The randomised
controlled trial is comparing treatment as usual (TAU) comprising 10 sessions with a medical
doctor (pharmacological treatment and psycho-education) and 16-21 sessions with a
psychologist (manual-based cognitive behavioural therapy) with add-on of the social
intervention. Overall, the intervention seeks to integrate working with social stressors
alongside treatment for trauma-related mental health problems. This is done in two ways; by a
cross-sectoral collaboration with municipality through collaborative meetings and by a
systematic focus on social stressors during the treatment.
The primary outcome is functioning, measured by WHODAS 2.0 12 item version together with a
variety of secondary outcomes measuring mental health symptoms, quality of life and degree of
social stressors.
RESULTS The study is expected to bring forward new perspectives and knowledge on psychosocial
treatment of trauma-affected refugees as well as cross-sectoral collaboration.
Description:
INTRODUCTION Treatment-seeking trauma-affected refugees possess a complexity involving past
trauma and ongoing social stressors, which challenges treatment of mental health problems.
There is therefore a great need for developing holistic cross-sectoral interventions, where
dealing with these complex challenges are integrated in treatment for trauma-related mental
health problems. This research gap has led to the present research study.
The overall aim of this study is to examine a psychosocial intervention with an integrated
cross-sectoral collaboration for refugees with post-traumatic stress disorder (PTSD) in a
randomised controlled trial (RCT) supplemented by a qualitative study.
For the RCT the objectives are:
1. To investigate the treatment effect of a psychosocial, cross-sectoral intervention on
outcomes of functioning, quality of life and mental health symptoms compared to
treatment as usual (TAU) at Competence Center for Transcultural Psychiatry (CTP).
2. To study social stressors as a predictor of severity of mental health symptoms, quality
of life and functioning at baseline.
3. To examine predictors for positive outcomes of treatment including social stressors as a
predictor.
Course of treatment and data collection will follow the SPIRIT statement
PATIENT RECRUITMENT Patients can be referred to the clinic by any MD. A senior psychiatrist
at CTP assess all referrals, and based on the referral, patients are invited for an initial
assessment by an MD at CTP. If it is clear from the referral that the patient does not belong
to the clinic's target group, the patient is not invited for an assessment.
Previously randomised trials in the CTP have included about 150 patients per year, and the
most recent project included 100 patients per year. In all trials 65-75 % of the patients
have completed the project. For the present trial the collaborating municipalities cover
about 80 % of the referred patients' municipal affiliation. Counteracting this, the
investigators expect more patients to be interested in participating in the present trial
compared to previous trials that have included psychopharmacological interventions. Therefore
approximately 200 project patients are deemed realistic within the given time frame.
INITIAL ASSESSMENT The initial assessment is scheduled for all patients that are assessed to
be in the target group of CTP. The content of the assessment is not specific for this trial
but applies to all initial assessments at CTP. The initial assessment is planned as 2-4
sessions of approximately 45 minutes with an MD, resulting in a total of about two-three
hours assessment and consists of; recording of the trauma history, the migration process,
social situation, somatic and psychiatric medical history, as well as a clinical and
diagnostic assessment. Standardised diagnostic tools such as part of Schedules for Clinical
Assessment in Neuropsychiatry (SCAN), the ICD-10 research criteria and the International
Trauma Interview (ITI) for ICD-11 section one (PTSD) will be applied in the interview.
Various instruments of symptom severity and functioning are completed as self- and observer
ratings. Oral and written information about the treatment and the trial is given. If the
patient fulfils eligibility criteria and consents to participate, the patient will be
randomised after the initial assessment.
RANDOMISATION All patients will be randomised after a total of two to three-hour initial
assessment with an MD in accordance with inclusion and exclusion criteria. An equal number of
patients are randomised in to the two groups (TAU and intervention). The actual randomisation
is carried out in REDCap (Research Electronic Data Capture). Stratification by the five
municipalities will be carried out before randomisation.
BLINDING Blinding patients and practitioners are not assessed to be appropriate due to the
different nature of the treatment interventions. However, an intervention-group blinded
Hamilton (depression and anxiety) rating will be carried out at the beginning and at the end
of treatment. Hamilton-raters will be trained at the clinic and will take part in regular
joint ratings to ensure high quality and interrater reliability.
Data assessment and data analysis will be performed blinded.
REPRESENTATIVITY Patients have not been selected based on more specific criteria than
elsewhere in the treatment system and are therefore representative for the population at
other clinics treating trauma-related mental health problems in refugees. The results can
thus be generalised to other corresponding patient groups and are directly applicable in the
planning of treatment for this patient population in general.
TRIAL FIDELITY In order to determine trial fidelity, patient attendance will be registered
and after each consultation with an MD, psychologist or social counsellor, the topics
addressed will be registered, as well as the methods used during the consultation and whether
the patient has completed his/her exercises between sessions as planned. At each consultation
with an MD any changes in medication will also be recorded.
VARIABILITY IN THE COURSE OF TREATMENT All patients will follow the predefined treatment
course as accurate as possible, but due to the pragmatic nature of the study there will
possibly be some variation in attendance and timing of meetings and sessions, as the patients
may become ill or for some other reason not show up for sessions or meetings.
FREQUENCY OF RATINGS Patients will be asked to complete self-ratings several times during
treatment: at the diagnostic interview/assessment, transition between phase 1 and phase 2,
and at the end of the treatment course. Observer ratings and blinded Hamilton ratings will
take place at the beginning and end of treatment.
In addition, ratings will also be carried out at follow-up 6 months after end of treatment.
DATA COLLECTION Data will only be collected at CTP and the municipalities are not involved in
any data collection or processing. After each session the clinicians will fill out the case
report form (CRF) in the research database through REDCap (Research Electronic Data Capture).
All ratings will be carried out by a CTP practitioner (MD, psychologist or social
counsellor). Blinded observer Hamilton ratings will be carried out by medical students not
linked to the team of practitioners, but to an independent Hamilton rating team with thorough
training in using the Hamilton rating scale. In order to ensure quality and inter-rater
reliability, the members in the Hamilton team participate regularly in joint ratings under
the guidance of one of the senior psychiatrists at CTP (six joint ratings per year). The
investigator is overall responsible for the data collection.
DATA SECURITY All data collected for this project will be protected according to the General
Data Protection Regulation (EU) 2016/679 (GDPR), Act on Processing of Personal Data as well
as the Danish Health Act. Information regarding the patients' health concerning trauma
history, the migration process, social situation, somatic and psychiatric medical history,
medicine, allergies, abuse of drugs or alcohol and ratings will be passed on from the patient
record to investigator.
SOURCE DATA All data registered about the patients will be kept as source data in the form of
original rating forms completed by the patients or practitioners, as well as structured
patient records. Data will be saved for 15 years after the trial has ended, which will be
stated in a letter of attorney signed by the patients. Case Report Form is source data, this
will be described in the source data document, which will be filed in the Trial Master File.
QUALITY ASSURANCE Quality control and quality assurance will follow regular procedures as
described in sections 3 and 4 of the Danish Executive Order on Good Clinical Practice (GCP).
The previous RCTs at CTP has been under GCP monitoring, but the GCP unit has assessed that
GCP monitoring is not necessary for the current trial as CTP is assessed to have high-quality
internal monitoring. The internal monitoring during the trial follows a manual and is carried
out by a team not directly involved in the data collection.
The trial is approved by the Danish Data Protection Agency through the Capital Region of
Denmark. Managing and filing data will be in accordance with current guidelines for research.
Manuals are used in sessions with all clinicians to establish shared standard procedures. In
order to ensure interrater reliability, all MDs will attend a SCAN course and regular joint
ratings including clinical assessment and observer-ratings will be carried out.
POWER CALCULATION A Minimal Clinically Important Difference score for the WHODAS 2.0 has not
yet been established. In the literature it has been difficult to find studies with
populations comparable to the present study. Based on clinical experience and the sparse
available literature a conservative Minimal Clinically Important Difference was taken to be 5
scale points on "WHODAS 2.0 12-item version" and within-groups SD was taken to be 10 scale
points. With a power level of 80 % and alpha 0.05 the investigators estimate a sample size of
each group of 64 and a total of 128. The completion rate in the preceding randomised trials
at CTP was two-thirds, and the investigators therefore set expected drop-out rate to 35 % for
this study. Therefore, the investigators increased the number of patients included to 128 x
(1/(100%-35%)) and consequently estimated a total sample size of 197 patients. Inclusion will
be stopped when approximately 197 patients have been included in the trial. It must be noted
that in the case that a Minimal Clinically Important Difference for WHODAS 2.0 is established
during the time frame of the trial, it will be considered in the analyses.
DROP-OUT ANALYSIS Drop-out analysis is based on the patients who show up at the pre-treatment
assessment. The participant will be compared to the patients, who were excluded at the
initial assessment on several dimensions in order to identify possible systematic selection
bias. The participants included in the trial, but who eventually drop out and do not complete
the trial, will be analysed in an intention-to-treat analysis. In addition, completer
analyses will be carried out.
DATA PROCESSING
1. The primary outcome variables are differences during the treatment course calculated as
differences between baseline and end of treatment ratings. The differences between the
two intervention groups can be measured with adjustment for baseline and stratification
variables by ANCOVA/linear regression and with multiple imputations to handle missing
data.
2. The role of social stressors as a predictor for baseline mental health symptom severity,
functioning and quality of life will be examined by linear regression with mental health
indices, respectively, as dependent variable and social factors as independent
variables.
3. Potential predictors of outcome can be analysed by linear regression. A number of
analyses are planned with changes in outcome measures as dependent variables and
independent variables of social stressors including age, gender and other demographic
and baseline data in an attempt to isolate predictors of positive outcome.
