|- candidate number||9274|
|- NTR Number||NTR2824|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-mrt-2011|
|- Secondary IDs||80-82310-97-11047 ZonMW|
|- Public Title||Everything under Control.|
|- Scientific Title||Cost-effectiveness of internet-based guided self-help for depressive disorders in specialized mental health care: A randomized controlled trial.|
|- ACRONYM||AOC-Do (Alles onder Controle Doelmatigheid)|
|- hypothesis||We test the hypothesis that guided self-help is not less effective and not more expensive than care-as-usual.|
|- Healt Condition(s) or Problem(s) studied||Depressive disorders, Depression|
|- Inclusion criteria||Patients who are:|
1. Being 18 years or older;
2. Diagnosed with a depressive disorder;
3. In a mental health care institute;
4. Who have access to a computer and the Internet;
5. Who are motivated to work on an Internet-based treatment.
The use of medication is accepted, as long as this was started before the referral to the mental health care institute, medication 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-sep-2010|
|- planned closingdate||1-sep-2014|
|- Target number of participants||263|
|- Interventions||The intervention we examine is the website 'Allesondercontrole', a brief problem-solving intervention based on cognitive behaviour therapy. This webbased intervention is available (for research purposes) and has been examined in two randomized controlled trials. The intervention takes 5 weeks. During that period the respondents indicate what they think is important in their lives, they make a list of their “problems and worries” and they categorize their problems into three groups: unimportant (not related to what they think is important in their lives), important and solvable (these problems are solved by a systematic problem-solving approach consisting of 6 steps), or important but unsolvable (for example having lost someone by death, having a chronic general medical disease; for these problems they make a plan how to live with it).|
The participants are supported by a coach, who gives feedback to the homework ssignments of the participants in brief, weekly emails. The total amount of time spent on each patient is about one and a half hour (estimate based on our earlier trials). The writing of these emails costs about 15 or 20 minutes per week, and will be done by a coach (nurse or social worker) of the participating institute.
The coaches will be trained by the psychologists who have developed the intervention. An independent psychologist will verify whether the coaches have followed the protocol sufficiently by reading a random selection of the emails.
The control group will receive care as usual.
|- Primary outcome||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);
6. Diagnostic Status (CIDI).
|- Timepoints||1. 0 week;|
2. 6 weeks;
3. 6 months;
4. 12 months.
|- Trial web site||www.allesondercontrole.nu|
|- CONTACT FOR PUBLIC QUERIES||PhD. Annemieke Straten, van|
|- CONTACT for SCIENTIFIC QUERIES||PhD. Annemieke Straten, van|
|- 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|
|- Brief summary||Although several meta-analyses have shown that internet-based guided self-help is effective in the treatment of depressive disorders, the cost-effectiveness in comparison with regular care in specialized 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 and not more expensive than care-as-usual. The intervention (Allesondercontrole.nu) is based on problem-solving therapy. The self-help intervention has been developed by the applicants and has been shown to be effective in two earlier randomized controlled trials. Care as usual is mostly pharmacotherapy, psychological treatment or the combination of the two, as described in the multidisciplinary guidelines.
|- Main changes (audit trail)|
|- RECORD||25-mrt-2011 - 1-apr-2011|