Plain English Summary
Background and study aims
People who suffer from psychosis very often also have other disorders at the same time, such as anxiety, depression or post-traumatic stress disorder (PTSD). Patients with psychosis and PTSD often ask for treatment of PTSD, but clinicians are reluctant to do so as they fear a worsening of symptoms, although there is no proof of this in the scientific literature. There are a number of small studies that show successful reduction of symptoms and no unwanted effects such suicidal ideation and gestures, worsening of symptoms, hospital admissions, crises contacts with the mental health services and so on. This study is treating PTSD in people with a lifetime psychotic disorder to find out if symptoms will reduce and no accidents will happen. It will compare two forms of therapy that have proven to be effective in the treatment of PTSD.
Who can participate?
Adults who have a lifetime psychotic disorder and PTSD and are registered in one of the 13 participating institutions.
What does the study involve?
Patients will be randomly allocated to one of three conditions: prolonged exposure (PE), eye movement desensitisation and reprocessing (EMDR), or waiting list. Prolonged exposure is a proven effective treatment for PTSD. The patient will have a maximum of eight 90-minute sessions. In the session people are asked to think, imagine and relive the most terrifying traumatic event. Recordings of the sessions have to be listened at home on a daily schedule. The experience is that anxiety will wane over time. When anxiety disappears another traumatic event is selected and the procedure is repeated. EMDR is also a proven effective treatment for PTSD. The patient is asked to relive the traumatic event and select the most horrible picture and describe what makes this event still so horrible. This is formulated in a negative cognition and a goal positive cognition is formulated as well. Then the patient is asked to imagine the most horrible picture and then look at the fingertips of the therapist, who waives the fingers back and forth. The patients eyes moves from left to right in a quite high pace. When anxiety disappears another traumatic event is selected and the procedure is repeated. The waiting list group has to wait for 6 months and then has the therapy of choice. All groups are assessed at the beginning, after two months at the end of treatment, and after 6 months. The PE and EMDR groups have a last assessment at 12 months. Patients who hallucinate are also assessed for two times during six days at the beginning and end of treatment with the PSYMATE. This is a device that looks like a mobile phone and rings ten times a day. The participant then has to answer some questions on the place he/she is, the company, the thoughts, the feelings, and his/her behaviour.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
The study is a multi-site study in 13 mental health services in the Netherlands. These are GGz Noord-Holland-Noord in Almaar and surroundings, Arkin in Amsterdam, GGz Duin en Bollenstreek (Leiden and surroundigs), Lentis (province of Groningen), Yulius (Dordrecht and surroundings), Altrecht (Utrecht and surrounidngs), Parnassia Psychiatric Institute (The Hague and Zoetermeer), Bavo-Europoort (Rotterdam), Pro Persona (Nijmegen and surroundings), GGz Eindhoven (Eindhoven and surroundings), GGz Oost Brabant (Boxmeer and Oss and surroundings), GGz Drenthe (province of Drenthe), GGNet (Apeldoorn, Doetinchem, Zutphen and surroundings).
When is study starting and how long is it expected to run for?
The study started in September 2011 and is expected to run for about three years. For the PE and EMDR patients the study will take 12 months: a 2-month treatment intervention with 6-month and 12-month follow-up assessments. The waiting list group will have a waiting period of 6 months and then a 2-month treatment phase.
Who is funding the study?
The study is funded by the Stichting tot Steun VCVGZ.
Who is the main contact?
Prof. dr. Mark van der Gaag
m.vander.gaag@vu.nl
Trial website
Contact information
Type
Scientific
Primary contact
Prof Mark van der Gaag
ORCID ID
Contact details
Prinsegracht 63
The Hague
2512 EX
Netherlands
+31 (0)645 780 463
m.vander.gaag@vu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NL36649.091.11
Study information
Scientific title
The effect of treatment of posttraumatic stress disorder in people with a lifetime psychotic disorder: a multi-site randomized controlled trial
Acronym
T-TIP
Study hypothesis
Are Eye Movement Desensitization and Reprocessing (EMDR) and Prolonged Exposure (PE) effective in treating posttraumatic stress disorder compared to waiting list in people with lifetime psychotic disorders?
Ethics approval
METiGG Ethics Comittee [Medisch-ethische Toetsingscommissie Instellingen Geestelijke Gezondheidszorg], 17/10/2011, ref: NL36649.097.11
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Psychosis and post-traumatic stress disorder/ psychiatry and psychology
Intervention
In all three arms treatment as usual will be provided for the psychotic disorder for which the person sought help. In the experimental arms there will be a maximum of 8 sessions (over two months) of either prolonged exposure or EMDR with a trained CBT therapist aimed at reducing PTSD symptoms. Treatment duration is two months, patients will be followed-up at 6 months and 12 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Clinician Administered PTSD Scale (CAPS) diagnosis and severity
2. PTSD Symptom Scale Self-Report (PSS-SR) severity
Secondary outcome measures
1. Influence on psychosis (PANSS 8-item Remission Tool, GPTS and DRS in case of delusions, AHRS and AVH-BAS in case of auditory hallucinations)
2. Depression (BDI-II)
3. Social functioning (PSP)
4. Adverse events (TTIP Adverse Events Questionnaire)
5. Quality of life and cost-effectiveness (EQ5D, TIC-P)
Overall trial start date
01/11/2011
Overall trial end date
01/11/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Lifetime psychotic disorder as assessed by MINI
2. PTSD as assessed by CAPS
3. Outpatient
4. Age 18 to 65 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
240
Participant exclusion criteria
1. IQ under 70
2. No competence of the Dutch language
3. Not willing or able to travel to treatment location
Recruitment start date
01/11/2011
Recruitment end date
01/11/2013
Locations
Countries of recruitment
Netherlands
Trial participating centre
Prinsegracht 63
The Hague
2512 EX
Netherlands
Sponsor information
Organisation
Stichting tot Steun VCVGZ (Netherlands)
Sponsor details
c/o Dr Fam Meuwese
PO Box 9219
Arnhem
6800 HZ
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Foundation for Support VCVGZ [Stichting tot Steun VCVGZ] (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: www.ncbi.nlm.nih.gov/pubmed/23702050
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25607833
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27449253
Publication citations
-
Protocol
de Bont PA, van den Berg DP, van der Vleugel BM, de Roos C, Mulder CL, Becker ES, de Jongh A, van der Gaag M, van Minnen A, A multi-site single blind clinical study to compare the effects of prolonged exposure, eye movement desensitization and reprocessing and waiting list on patients with a current diagnosis of psychosis and co morbid post traumatic stress disorder: study protocol for the randomized controlled trial Treating Trauma in Psychosis., Trials, 2013, 14, 151, doi: 10.1186/1745-6215-14-151.
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Results
van den Berg DP, de Bont PA, van der Vleugel BM, de Roos C, de Jongh A, Van Minnen A, van der Gaag M, Prolonged Exposure vs Eye Movement Desensitization and Reprocessing vs Waiting List for Posttraumatic Stress Disorder in Patients With a Psychotic Disorder: A Randomized Clinical Trial, JAMA Psychiatry, 2015, doi: 10.1001/jamapsychiatry.2014.2637.
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Results
van den Berg DP, van der Vleugel BM, de Bont PA, Staring AB, Kraan T, Ising H, de Roos C, de Jongh A, van Minnen A, van der Gaag M, Predicting trauma-focused treatment outcome in psychosis, Schizophr Res, 2016, -S0920-9964(16)30332-2, doi: 10.1016/j.schres.2016.07.016.