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van CCT (UK)

van CCT (UK)

Addition of the SUPPORT Coach in PTSD treatment

- candidate number28376
- NTR NumberNTR6912
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-dec-2017
- Secondary IDsNL63180.018.17 Toetsingsonline
- Public TitleAddition of the SUPPORT Coach in PTSD treatment
- Scientific TitleFeasibility, acceptance and potential improvement of trauma-focused therapy in PTSD patients with a smartphone application - a pilot study
- hypothesisWe hypothesize that the usage of the SUPPORT Coach app by patients with PTSD in addition to their traumafocused therapy will lead to a reduction of post-traumatic stress symptoms compared to patients in treatment that do not use the app.
- Healt Condition(s) or Problem(s) studiedTrauma related complaints (e.g. anxiety, depression), Post-Traumatic Stress Disorder (PTSD), Posttraumatic stress symptoms
- Inclusion criteria Adults, minimum 18 years of age Referred to a mental health care institute for traumafocused psychotherapy for PTSD following one or more traumatic experiences Meet the DSM-5 diagnostic criteria for PTSD as confirmed by the CAPS-5 In possession of a mobile phone working on ANDROID/IOS operating systems Have sufficient understanding of the Dutch language (speaking, writing, listening)
- Exclusion criteria Having current high risk for suicide according to M.I.N.I-C Having serious psychiatric co-morbidity, i.e. psychotic illness, bipolar affective disorder, substance-related disorders, severe personality disorder or mental retardation Not having access to a smartphone with an internet connection
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-okt-2017
- planned closingdate1-mei-2019
- Target number of participants60
- InterventionsThe intervention group receives access to the SUPPORT Coach, a mobile application aiming to help people better understand and self-manage their PTSD symptoms. The SUPPORT Coach includes psychoeducation, a self-test with a monitoring feature, and, most importantly, various exercises and tools to cope with PTSD symptoms. Examples are deep breathing, progressive muscle relaxation, and positive imagination exercises (
- Primary outcomePotential improvement of trauma-focused therapy: Does usage of the SUPPORT Coach app in-between treatment sessions potentially enhance the efficacy of traditional trauma-focused therapy in terms of PTSD symptom reduction? Measured by the difference in PCL-5 score reduction (continuous) between the intervention- and control condition at the start of therapysession 6 and 13 of the traumafocused psychotherapy.
- Secondary outcomeFeasibility and acceptance of the SUPPORT Coach app as an adjunct to traditional trauma-focused psychotherapy. Are patients willing to use the SUPPORT Coach as an additional tool in between therapy sessions? How often would they use the app and are they able to use the app on their own
- TimepointsThe primary outcome is assessed at multiple time points:
1. Before treatment (baseline)
2. A measurement at the start of the first 12 treatment sessions
3. Posttreatment at the 13th session

Secondary outcomes are assessed pre- and post-treatment and by means of log files during the intervention period
- Trial web
- statusplanned
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Stichting tot Steun (VCVGZ)
- Publications
- Brief summaryPosttraumatic stress disorder (PTSD; life time prevalence in the Netherlands 7.4%) can occur after a traumatic event. Effective psychological treatments are available, but approximately one-third of the treated patients do not benefit sufficiently and residual symptoms are a considerable problem. The need to optimize treatment warrants moving beyond traditional methods. Mobile mental health is a promising development in this regard. In the proposed study, the aim is to investigate the feasibility, acceptability and potential efficacy of the SUPPORT Coach, a smartphone application that helps to understand and cope better with PTSD symptoms, as a tool complementary to traditional trauma-focused therapy
- Main changes (audit trail)
- RECORD22-dec-2017 - 5-jan-2018

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