|- candidate number||13156|
|- NTR Number||NTR3536|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-jul-2012|
|- Secondary IDs||41224.OVKonline |
|- Public Title||Evaluation of the online course The stories we live by.|
|- Scientific Title||The stories we live by: A randomized controlled trial into the effects of a guided online self-help intervention based on integrative reminiscence for adults in the second half of life with mild to moderate depressive complaints.|
|- ACRONYM||Online course The stories we live by|
|- hypothesis||Both intervention groups, ‘the stories we live by + counselor’ and ‘the stories we live by + peer contact’, are superior to the control group in terms of clinical outcomes (reduction of depressive symptoms and improvement of positive mental health).|
|- Healt Condition(s) or Problem(s) studied||Internet-based guided self-help, Depression, Mental health problems, Integrative reminiscence|
|- Inclusion criteria||1. Age 40 years and over;|
2. The presence of mild to moderate depressive complaints (CES-D score ≥ 10).
|- Exclusion criteria||1. The presence of severe depressive complaints according to the M.I.N.I.;|
2. A moderate or high risk of suicidality according to the M.I.N.I.;
3. Recently started with medication therapy for somberheids complaints (3 months ago);
4. Receiving an ongoing psychological (self-help) treatment for depressive complaints;
5. Not enough time to follow the course well;
6. Poor mastery of the Dutch language (read or learning difficulties);
7. No email address or no access to the internet.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2012|
|- planned closingdate||1-mrt-2014|
|- Target number of participants||186|
|- Interventions||The online self-help course is based on the self-help book "The stories we live by," and makes use of integrative reminiscence (life review). The intervention consists of six modules over 12 weeks.
The experimental group The stories we live by + counselor receive 2-weekly feedback and support from the counselor via e-mail.
Participants in the experimental group The stories we live by + peer contact individually follow the course, but react on each other 2-weekly. A peer group consists of 4 participants.
The control group will be on a waiting list.
|- Primary outcome||The primary outcome measure is reduction of depressive symptoms, measured with the CES-D. |
|- Secondary outcome||The secondary outcomes are improvements in health status (measured by the EQ-VAS, subjective health and functional limitations), positive mental health (measured by the MHC-SF), vitality (measured by the vitality subscale of the MOS SF-36), mastery (measured with the Pearlin Mastery Scale) and social support (measured by the SSL-12-I), and a reduction of loneliness (measured with the loneliness Scale).|
|- Timepoints||Outcomes are measured at baseline and 3, 6 and 12 months after baseline.|
|- Trial web site||www.cursusopverhaalkomen.nl|
|- CONTACT FOR PUBLIC QUERIES||Dr. M.G. Postel|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M.G. Postel|
|- Sponsor/Initiator ||University of Twente|
(Source(s) of Monetary or Material Support)
|University of Twente|
|- Brief summary||The University of Twente has developed an online preventive self-help course 'The stories we live by Online', with additional e-mail guidance of a counselor (The stories we live by + counselor) or online with peer contact (The stories we live by +peer contact). The course can be followed by participants at home in their own time. This study investigates the effects of the two variants of the course on depressive symptoms and well-being, compared with a waiting list control group, through a randomized controlled trial.|
|- Main changes (audit trail)|
|- RECORD||20-jul-2012 - 6-dec-2012|