a. By this research a treatment protocol for NET will be quantitatively and qualitatively evaluated on its effects. b. With the research findings it is possible to identify subgroups within the research population and indicate who benefits most from…
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Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary research variables:
Symptoms and severity of PTSD: Clinician Administered PTSD Scale (CAPS) +
Harvard Trauma Questionnaire (HTQ-16)
Secondary outcome
Symptoms and severity of depression: Beck Depression Inventory (BDI-II);
Quality of life: WHO Quality of Life Assessment (WHOQOL-Bref);
Self-efficacy: Self Efficacy Scale (SES);
Attribution of meaning: Meaning of War Scale ( MoWS);
Anger and aggression: State-trait Anger Scale (STAS);
Syndromes of pathology: Brief Syndrome Inventory (BSI-53);
Qualitative results of short interview (attribution of meaning, treatment
process)
Background summary
In mental health services older adults with trauma-related psychopathology
present a growing population. According to recent research (Van Zelst, 2006)
the prevalence rate of Post Traumatic Stress Disorder (PTSD) among the older
population in the Netherlands varies from 1% (full criteria) to 13%
(subthreshold PTSD). The disorder is often associated with comorbid disorders
and high usage of medical services. Patients with PTSD are often not
recognized, incorrectly diagnosed and inappropriately treated. One can speak of
robust but hidden health problems. Trauma-related psychopathology has severe
impact on the quality of life. Effective trauma-treatment for older adults may
enhance their health and wellbeing and diminish medical consumption. With
effective trauma-treatment for older adults it is possible to develop a
specific outpatient treatment setting for older adults short-term,
protocol-driven interventions. In this way it will in many cases be possible to
shorten treatment time and prevent clinical admission. Diminishing medical
consumption may reduce expenses for mental health services and enhance the
quality of life of this population.
For traumafocused psychotherapy, exposure (real-life or imaginary) is proven an
effective treatment procedure and the treatment of choice (Multidisciplinaire
richtlijnen voor angststoornissen, 2003, van Minnen, 2008). For older patients
however, classical exposure procedures can present a major burdening of their
emotional capacities (Multidisciplinaire richtlijnen voor angststoornissen,
Addendum ouderen, 2008). What is more, Cognitive Behavior Therapy (CBT) and Eye
Movement Desensitisation and Reprocessing (EMDR) are appropriate for treating
one or few traumatic memories. Older adults may suffer from multiple
traumatization and may have the need to put their experiences into order within
a context of meaning. Narrative Exposure Therapy or NET (Schauer, Neuner &
Elbert, 2011) is a technique for exposure, for multiple and/or sequential
traumatization and combines exposure with attribution of meaning. Therefore NET
seems more suitable as a trauma-treatment for older adults than classical CBT
or EMDR. NET is a form of exposure therapy, based on recent theories of
cognitive and emotional processing, in which narrative (autobiografic) elements
are integrated. This treatment intervention is developed for adults and
children in a context of emercency aid in post-conflict areas. Is this
intervention also effective for older patients in the context of Dutch mental
health care? To answer that question NET will be evaluated on its effects in a
randomized controlled trial (RCT) with older patients with trauma-related
psychopathology at Foundation Centrum *45. The experimental intervention (NET)
will be compared with Present Centered Therapy (Schnurr e.a., 2005) as a
control condition for the non-specific therapeutic elements. The measurements
do not only apply to symptoms, but also to quality of life and attribution of
meaning. It is expected that NET will constitute an effective part of future
ambulatory treatment services for older patients with trauma-related
psychopathology.
References:
Multidisciplinaire richtlijnen GGZ (2003). Multidisciplinaire richtlijn
angststoornissen. Stuurgroep Multidisciplinaire Richtlijnontwikkeling GGZ.
Utrecht, Trimbos-instituut. www.trimbos.nl.
Minnen, A. van (2008). Wie durft? PhD-thesis. St. Radboud Universiteit,
Nijmegen.
Schauer, M., Neuner, F. & Elbert, T. (2005). Narrative Exposure Therapy. A
Short-term Intervention for Traumatic Stress Disorders after War, Terror or
Torture. 2nd revised and expanded edition. Göttingen: Hogrefe & Huber
Publishers.
Schnurr, P.P., Friedman, M.J., Engel, C.C. Foa, E.B., Tracie Shea, M., Resick,
P.M., James, K.E., Chow, B.K. (2005). Issues in te design of multisite trials
of psychotherapy: VA Cooperative Study No. 494 as an example. Contemporary
Clinical Trials 26 (2005) 626-636. Elsevier Inc.
Zelst, van W.H. (2006). Posttraumatic Stress Disorder in late life. Groningen,
The Netherlands.
Study objective
a. By this research a treatment protocol for NET will be quantitatively and
qualitatively evaluated on its effects.
b. With the research findings it is possible to identify subgroups within the
research population and indicate who benefits most from the NET treatment
protocol.
c. Based on this research adaptations in the existing protocol may be proposed
to make a better fit of NET for older patients. If necessary the intervention
will be adapted to specific sub-groups.
d. This research will enable us to develop an ambulatory setting for short-term
trauma-treatments for older patients.
e. This research will enable us to develop a treatment manual in Dutch for NET
and to offer training in working with NET.
Study design
The study will take place at Foundation Centrum '45, the national Dutch
treatment centre for psychotrauma following war, persecution and violence and
Sinai Centre, Jewish Mental Health institution. The participants are older
adults (>55 years of age), for whom individual ambulatory traumafocused
treatment has been indicated.
A sample size of N=80 (N=40 participants for the experimental condition and
N=40 participants for the control condition) is estimated large enough for
finding moderate effect sizes and comparing the results with the findings of
other research on NET. For research ends a NET-protocol will be developed,
based on the general treatment manual of NET (Schauer, Neuner & Elbert, 2011).
Besides, a protocol for PCT (Bernardy et al., 2003) will be followed. The
participants are assigned at random to 11 sessions of one of both
interventions (each N=40). Before the main study is started, the research
procedure and both protocols will be tested on feasability in a pilot study.
This study will have a quantitative and a qualitative character. In the
qualitative part content analysis and form analysis (MAXQDA) will be used. The
interviews will consist of eight standardized questions. In the quantitative
part a repeated measures design with two groups will be used. The participants
will be randomly assigned to one of two interventions: the experimental
condition or the control-condition. For assigning the participants a
computer-program will be used of single treatment allocation with randomly
permuted blocks (www.randomization.com). Measures will be taken to safeguard
blinding for the researchers during assessments. The two groups will be
compared on different moments. For each participant there will be four
measurements: the clinical interview at inclusion, measurements before and
after treatment and one follow-up measurement at four months after completing
the intervention.
Intervention
Narratieve Exposure Therapy (NET) is a form of exposure therapy, based on
recent theories of cognitive en emotional processing, in which narrative
(autobiografical) elements are integrated. NET (Schaer, Neuner & Elbbert, 2011)
is een short-term individual intervention (four to fifteen sessions), in which
patients with posttraumatic stress symptoms look back on their life trajectory
together with their therapist. There is attention for positive and adverse
events and experiences. Exposure takes place for the traumatic memories; in
this process the therapist supports the patient in an active and directive way.
Positive memories are honoured as well. This approach seems suitable to
multiple traumatic memories and combines exposure with attribution of meaning.
The resulting narrative is documented and can be used by the participant as a
witness document of important life experiences. In Foundation Centrum *45 NET
is performed on a regular basis with adults as individual traumafocused
psychotherapy with good results.
The NET-treatment condition exists of 11 weekly sessions of 90 minutes
duration. The Present Centered Therapy (Schnurr e.a., 2005) exists of 11 weekly
sessions of 90 minutes duration. Both interventions start with one introductory
sessions to establish a working alliance, to construct a shared explanatory
model and to formulate treatment goals. The consent for videotaping the
sessions will be discussed. The explanatory model of the patient is discussed
and psychoeducation on PTSD en the treatment condition will be offered.
In the NET-treatment the NET-protocol will be followed. In the session
following the introductory session an overview of the life trajectory will be
made. In the following eight sessions exposure on the traumatic experiences
will be offered. The last session is for looking back on the therapy, offering
the document and saying goodbye. The next assessment will be announced. All
sessions will be videotaped, with written consent of the participant. The
NET-sessions are performed by health-care psychologists, psychotherapists or
clinical psychologists,all with the Dutch professional registration (BIG), with
the assistance of the research assistant. A manual for the therapists will be
developed. In the manual the therapist may find information about the
research-process and guidelines about the content of treatment. All
NET-therapists will be trained in the NET-method. This training will be offered
by the NET-team that developed the method or by colleagues who are experienced
NET-therapists. All NET-therapists will have fulfilled at least an elementary
training. Control of protocol adherence will take place with the help of the
videotapes and a reliability-scale for NET.
In the control-condition the PCT-protocol (Bernardy et al., 2003) will be
followed. After the introductory session participants continue with nine
sessions of Present Centered Therapy. The last session is for looking back on
the therapy and saying goodbye. All sessions will be videotaped, with written
consent of the participant. A manual for the therapists will be developed. In
the manual the therapist may find information about the research-process and
guidelines about the content of treatment. All PCT-therapists will be trained
in the PCT-method. This training will be offered by therapists who are familiar
with this method. The Present Centered Therapy adresses current interpersonal
problems but avoids a trauma focus. Control of protocol adherence will take
place with the help of the videotapes and a reliability-scale for PCT
References:
Bernardy, N. Davis, N., Howard, J., Key, F., Lambert, J., Shea, M.T., (2003).
Present-Centered Therapy (PCT) Manual)
Schauer, M., Neuner, F. & Elbert, T. (2011). Narrative Exposure Therapy. A
Short-term Intervention for Traumatic Stress Disorders after War, Terror or
Torture. 2nd revised and expand ededition. Göttingen: Hogrefe & Huber
Publishers.
Schnurr, P.P., Friedman, M.J., Engel, C.C., Foa, E.B., Tracy Shea, M., Resick,
P.M., James, K.E., Chow, B.K. (2005). Issues in the design of multisite
clinical trials of psychotherapy: VA Cooperative Study no. 494 as an example.
Contemporary Clinical Trials 26. 626-636.
Study burden and risks
Risks are prevented by application of the criteria of exclusion. Furthermore,
by taking informed decisions about the criteria of inclusion under
medical-psychiatric supervision
and by performing the research treatments by qualified professionals with
adequate training and supervision
and well-controlled treatment protocolls.
Burden:
At indication the question will be included if a patient fulfills the criteria
of inclusion. Is this the case, he/she is asked to participate at the moment of
the regular advisory session. The information is offered by the researcher or
his assistant. The written information about the research will be offered for
informed consent. This information will need 30 minutes at its most.
Patients who decide not to participate are offered a regualr and suitable
treatment at Foundation Centrum '45. Patients may need deliberation time. Seven
to ten days seems reasonable. Patients who decide, after written consent, to
participate will fill out extra questionnaires. Patients will be assigned at
random to one of two conditions: NET or PCT.
Each possible participant of the research will perform a clinical interview
before the baseline measurement. In this clinical interview the criteria of
exclusion are tested. This clinical interview will take 140 minutes. If
necessary the patients will be supported by a research assistant.
Each treatment consists of eleven weekly sessions of 90 minutes duration.
Before treatment (baseline), after the last session and four months after
completing the intervention there will be a measurement. After the last
measurement patients can discuss a possible follow-up treatment with their
therapist. Who decides, for whatever reason, to finish participation in the
research before completing the research-treatment, can continue his/her
treatment in a different way.
So the burden for participants consists of information (30 minutes at most),
the clinical interview (140 minutes), three measurements (each about 180
minutes) and a research intervention (eleven sessions of 90 minutes). If
necessary assistance for the measurements will be offered, but in such a way
that blinding of the researchers will be safeguarded.
Nienoord 5
Diemen 1112 XE
NL
Nienoord 5
Diemen 1112 XE
NL
Listed location countries
Age
Inclusion criteria
Patients of Foundation Centrum '45 and Sinai Centre, older than 55 years of age,
with a DSM-IV classification of (full or subthreshold) Post Traumatic Stress Disorder
and a treatment indication of individual outpatient trauma focused Psychotherapy, without the need for assistance of interpreters
Exclusion criteria
Substance dependence
Remittance of substance dependence should be at least 3 months;
Psychotic disorder
Current manic or bipolar disorder
Severe depressive disorder (with suicidal or psychotic symptoms)
Cognitive impairments or cognitive disorder;
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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CCMO | NL40757.058.13 |