|- candidate number||7800|
|- NTR Number||NTR2233|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-feb-2010|
|- Secondary IDs||30976 CCMO|
|- Public Title||"Phobias under control".|
|- Scientific Title||Internet-based treatment of phobias in specialized mental health care: A randomized trial.|
|- ACRONYM||FocD (Fobieen onder controle Doelmatigheid)|
|- hypothesis||We want to test the hypothesis that internet based guided self-help is not more expensive and not less effective than usual care for patients with phobias. |
|- Healt Condition(s) or Problem(s) studied||Anxiety disorders, Phobias|
|- Inclusion criteria||Patients who are diagnosed with a social-, agora-, or specific phobia in a mental health care institute are eligible. To confirm the diagnosis a diagnostic interview will be done by an independent research assistant.|
Inclusion criteria are:
1. Being 18 years or older;
2. Having access to the internet;
3. Being motivated to work with a guided self-help intervention.
The use of medication is accepted, as long as this was started before the referral to the mental health care institute, the use is stable and the patient has no intention to change it.
|- Exclusion criteria||1. Another severe psychological disorder (psychotic disorder, bipolar disorder);|
2. An increased risk for suicide;
3. Co-morbidity is no reason for exclusion, as long as the phobia is the primary disorder.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2010|
|- planned closingdate||1-okt-2014|
|- Target number of participants||320|
|- Interventions||The internet course (FobieŽn onder controle) is based on exposure therapy. This intervention is based on
a published self-help book (written by drs. Manja de Neef and prof. Cuijpers), which was used in a series of television programme on self-help for phobias (by broadcasting company Teleac/Not). This treatment is based on exposure therapy in which the patients gradually exposes himself or herself to the feared situation. |
The intervention consists of five weekly parts, and includes reading materials and homework assignments for every week. The internet-based intervention is already available and is tested in a pilot project. During the therapy the patient has about five contact moments with the coach (total time per client 50 to 75 minutes). The coaching is aimed at supporting the patients to work through the intervention and assignments, not to develop a therapeutic relationship. The coaching is given by Mthese students from our faculty, who will receive a training from the developers of the intervention. Integrity of the intervention is checked by an independent psychotherapist.
The control group will receive care as usual.
|- Primary outcome||1. Fear Questionnaire (FQ);|
2. Beck Anxiety Inventory (BAI);
3. Center for epidemiologic studies- Depression (Ces-D).
|- Secondary outcome||1. Client Satisfaction Questionnaire (CSQ);|
2. Short Form- Helath and labour Questionnaire (SF-HLQ);
3. Quality of life in Economic evaluations (EQ-5d);
4. Trimbos/imta Tic-P questionnaire for costs associated with psychiatric illness (Tic-P);
5. Cut-Anoyed-Guilty-Eye opener (CAGE -alcohol questionnaire).
|- Timepoints||1. 0 week;|
2. 5 weeks;
3. 3 months;
4. 6 months;
5. 9 months.
|- Trial web site||www.fobieenondercontrole.nl|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MSc. R.N. Kok|
|- CONTACT for SCIENTIFIC QUERIES||MSc. R.N. Kok|
|- Sponsor/Initiator ||Vrije Universiteit, Faculteit der Pedagogiek en Psychologie|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||Kok, R. N., van Straten, A., Beekman, A. T. F., Bosmans, J. E., de Neef, M., & Cuijpers, P. (2012). Effectiveness and cost-effectiveness of web-based treatment for phobic outpatients on a waiting list for psychotherapy: protocol of a randomised controlled trial. BMC Psychiatry, 12(1), 131. doi:10.1186/1471-244X-12-131
Kok, R. N., van Straten, A., Beekman, A. T. F., & Cuijpers, P. (2014). Short-Term Effectiveness of Web-Based Guided Self-Help for Phobic Outpatients: Randomized Controlled Trial. Journal of Medical Internet Research, 16(9), e226. doi:10.2196/jmir.3429
|- Brief summary||Although several meta-analyses have shown that internet-based guided self-help is effective in the treatment of anxiety disorders, the cost-effectiveness in mental health care settings has not been studied well. We will conduct a randomized non-inferiority study in which we examine the relative cost-effectiveness of internet-based guided self-help as compared to usual care.|
We will test the hypothesis that guided self-help is not less effective than care-as-usual. Based on international studies we expect this intervention to be effective. Care as usual is mostly pharmacotherapy or psychological treatment. A total of 320 clients suffering of a phobia from 4 institutes of mental health care institutions will be randomized to care-as-usual or guided self-help.
The intervention is an internet-based guided self-help course (FobieŽn onder controle) which is based on
exposure. The control group receives a selfhelpbook. The primary outcome measure is level of phobic symptoms , anxiety and depression. Secondary outcomes will be panic-symptoms, satisfaction with the intervention and the use of alcohol and or drugs.
|- Main changes (audit trail)|
|- RECORD||28-feb-2010 - 18-okt-2014|