The current study aims to assess the effectiveness of added WBT to TFT (combined sessions of individual WBT and individual TFT during the first 6 months) at the beginning of the treatment for people with PTSD on mental well-being compared to care as…
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
Synonym
Health condition
posttraumatische en stressgerelateerde stoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of the study is the mental well-being as measured with the
Mental Health Continuum-Short Form.
Secondary outcome
Other parameters are the level of PTSD symptoms (PCL-5),
drop out (observation and the diary filled out by therapists)
the level of anxiety symptoms (The Hospital Anxiety Depression Scale),
the level of depression symptoms (The Hospital Anxiety Depression Scale),
psychological well-being (Positieve Geestelijke Gezondheidsschaal).
Background summary
The lifetime prevalence of post-traumatic stress disorder (PTSD) in the
Netherlands has been estimated on 7.4%. Treatment for PTSD is necessary because
left untreated, PTSD can become a chronic condition that engenders long-term
social and functional impairment. From a societal perspective, mental illness
is costly, often resulting in diminished productivity and increased rates of
service utilization. In the Mental Health Care Institutions in The Netherlands,
the overall focus for treating PTSD is to reduce symptoms of PTSD as
recommended in the Clinical Practice Guideline (2017) for Psychotrauma and
Stressrelated Disorders and subscribed by the newest Health Care Standard for
Psychotrauma and Stressrelated Disorders (in press, Klaassen, et.al.). During
those trauma-focused treatments (TFT), less attention is given to increase the
mental well-being of people with PTSD right at the beginning of the treatment.
According to the World Health Organization (WHO, 2001), health cannot be
defined as the absence of disease or infirmity but needs to be defined as a
state of complete physical, mental and social well-being. There is a growing
interest for positive psychology interventions (PPIs) in clinical settings,
wherein the focus is on eliciting positive feelings, cognitions or behaviors. A
recent review shows that PPIs in clinical settings not only have the potential
to improve well-being, but can also reduce distress in populations with
clinical disorders. Another important issue in relation to TFT is the level of
drop out. Although TFTs have been shown to be effective for PTSD, 36% of
individuals with PTSD drop out of these exposure-based treatments. In the
clinical practice patients with PTSD are treated as subscribed by the Clinical
Practice Guideline and Health Care Standard mainly focused on reducing symptoms
right at the beginning of the treatment but not on (1)strengthening the mental
well-being nor on (2) decreasing the drop out rates. Well-being therapy (WBT)
is a novel psychotherapeutic intervention with the aim to improve a healthy and
individualized path to positive mental health. This therapy can have a superior
effect on both, the well-being and the drop out rate when offered at the
beginning. WBT has been employed in several clinical studies where-in
researchers combined WBT with cognitive behavior therapies with result. One
recent study in the Netherlands added WBT to the end of the treatment for
patients with PTSD, when PTSD symptoms have already been decreased. Yet, no
studies have investigated the combination of WBT with TFT right at the
beginning of the treatment, with the aim of strengthening the well-being and
reducing symptoms.
Study objective
The current study aims to assess the effectiveness of added WBT to TFT
(combined sessions of individual WBT and individual TFT during the first 6
months) at the beginning of the treatment for people with PTSD on mental
well-being compared to care as usual (CAU), which is individual TFT. It is
hypothesized that the combination treatment WBT+TFT at the beginning is
superior compared to CAU on the mental well-being, the severity of PTSD
symptoms, the rates for drop out for any reason, psychological well-being and
severity of depressive and anxiety symptoms.
Study design
A randomised, controlled intervention study with two conditions. Measurements
take place at baseline, at mid treatment and after treatment.
Intervention
The present study will be the first study to examine the combination of
individual TFT with WBT for patients with PTSD. The participants will get
combined sessions of WBT and TFT during the first 6 months. The participants
will get the same 12 individual TFT interventions (12 individual sessions, 45
minutes) as in the CAU but combined with 6 individual sessions of WBT (45
minutes every two weeks). The WBT consists of 6 individual sessions of 45
minutes each using a structured protocol which are given in-between TFT
sessions. The participants of the control group will receive care at usual
(CAU): 12 individual TFT sessions (45 minutes).
Study burden and risks
The duration of the study will be around 6 months for each individual from
baseline to completion of the treatment. During this study, participants
complete three assessments of approximately 30 minutes each. Additionally, the
experimental group will have 6 added WBT sessions (45 minutes each) to TFT
compared to CAU. Every 2 weeks they will have a combined WBT +TFT session,
which implies 45 minutes extra to the TFT session. Participants in the
experimental group will spend approximately 5-10 additional minutes a day
exercising at home in these 6 months, during the 6 weeks wherein they receive
the combination treatment WBT +TFT (6 weeks * 10 minutes a day = 420 minutes in
total for additional homework)' Participants are free to participate in the
study. Subjects can leave the study at any time for any reason if they wish to
do so without any consequences. The therapists can decide to withdraw a subject
from the study for urgent medical reasons. All therapists are well trained in
both treatments and will participate in intervision sessions during the study.
Raiffeissenstraat 44
Enschede 7514 AM
NL
Raiffeissenstraat 44
Enschede 7514 AM
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: participants are between 18-65 years old and participants have been diagnosed with PTSD (according to DSM-5). Participants are included when they have a higher score than 33 (cutt-off) on the PTSD Checklist for the DSM- 5(PCL-5).
Exclusion criteria
1) participants diagnosed with PTSD that can be treated in the general Mental Health Care and have a score lower than 20 on the PTSD Symptom Scale (cutt off for PTSD: 15, 86%) , (2) subjects who need immediately and high intensive (clinical) care and are at a suicidal condition assessed by the Chronological Assessment of Suïcide Events (conform the Dutch Multiple Discipline Guideline for Suicidal risk, van Hemert et.al, 2012), (3) subjects who immediately need other medical interventions (for instance medication) or other behavioural/ psychological interventions; (4) subjects who don*t speak Dutch, (5) when the team has serious doubts about the competences of the patient,
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL66400.044.18 |
OMON | NL-OMON29633 |