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van CCT (UK)

van CCT (UK)

Psyfit, an internet-based intervention in order to promote well-being.

- candidate number6767
- NTR NumberNTR2126
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-nov-2009
- Secondary IDsNL28769.097.09 CCMO
- Public TitlePsyfit, an internet-based intervention in order to promote well-being.
- Scientific TitlePsyfit, an internet-based intervention in order to promote well-being. The design of a randomised controlled trial.
- hypothesisThe internet-based self-help intervention is effective in the enhancement of well-being, the reduction of depressive symptoms and in terms of economic costs in comparison to a waiting list control group.
- Healt Condition(s) or Problem(s) studiedDepressive symptoms
- Inclusion criteriaSubjects:
1. Are 25 years or older;
2. Have very mild to moderate depressive symptoms as measured by the Center for Epidemiological Studies Depression Scale (CES-D) in a score 10 or higher ŕnd moderate or low well-being as measured by the cut-off points in the Mental Health Continuum (Keyes, Keyes and Westerhoff);
3. Have access to a computer and a good internet connection;
4. Have sufficient knowledge of the Dutch language.
- Exclusion criteria1. Serious depressive complaints (score CES-D >=25);
2. Suicideal ideation (active suicidal thoughts or plans, score Web Screening Questionnaire 2 or 3).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2009
- planned closingdate1-nov-2010
- Target number of participants414
- InterventionsThe intervention concerns a multiple internet-based self-help intervention (‘Psyfit’) aimed at the promotion of well-being en the reduction of depressive symptoms. Based on their needs and current level of well-being they can choose one out of six modules. Each module consists of a four-week program with theoretical information, short films and assignments. Participants can monitor their progress in a personal plan and a mood meter. For sharing experiences and peer-to-peer support an online community is available. Participants are randomized to the intervention of a waitinglist control group. Participants in the watinglist control group are able to attend the intervention 6 months after T0.
- Primary outcomeWell-being (WHO-5 and Mental Health Continuum-Short Form) and depressive symptoms (CES-D).
- Secondary outcomeGeneral health and vitality (subscales in MOS-SF36), economic costs (care consumption; TIC-P / work productivity, absenteeism, inefficient job performance; PRODISQ).
- Timepoints1. t0: baseline;
2. t1: post test, 2 months after t0;
3. t2: follow-up, 6 months after t0.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Trimbos-institute - Netherlands Institute of Mental Health and Addiction
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Health, Welfare and Sports
- PublicationsN/A
- Brief summaryThe aim of the study is to evaluate the (cost-)effectiveness of Psyfit, an online mental fitness self help program, on well-being and depressive symptoms. The study design is a two-armed pragmatic randomised controlled trial:
1. 2-month access to Psyfit (experimental condition);
2. Waiting list for 6 months (control condition).
Measurements will be made prior to inclusion and randomisation (t0), 2 months after starting the intervention (t1), 6 months after starting the intervention (t2).
- Main changes (audit trail)
- RECORD30-nov-2009 - 22-jan-2010

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