|- candidate number||9164|
|- NTR Number||NTR2778|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-feb-2011|
|- Secondary IDs||NL34229.097.10 METC METIGG|
|- Public Title||Storying one's life: A randomized controlled trial for the effects of a guided self-help intervention based on integrative reminiscence for adults in the second half of life with mild to moderate depressive symptoms.|
|- Scientific Title||Storying one's life: A randomized controlled trial for the effects of a guided self-help intervention based on integrative reminiscence for adults in the second half of life with mild to moderate depressive symptoms.|
|- hypothesis||Depression is a significant health problem. By far the most important risk factor of major depressive disorder is the presence of depressive symptoms. Prevention is important to reduce the amount of new cases of depression. International research indicates that integrative reminiscence leads to a reduction in depressive symptoms and other psychological symptoms. Integrative reminiscence is a low threshold intervention specifically developed for the adults in the second half of life, and directed at an active re-evaluation of one's life. The intervention was effective as a group intervention in decreasing psychological symptoms and increasing well-being. Therefore, the University of Twente developed a self-help intervention with counseling by e-mail. In this project the effectiveness of "Storying one's life" is investigated. The effects of the course on depression, psychological symptoms and well-being are investigated by means of a randomized controlled trial. Hypothesis: The intervention group is superior to a control group " no prevention", and superior to a control group with a minimal intervention in clinical outcome measures (reducing depressive symptoms, improving well-being).|
|- Healt Condition(s) or Problem(s) studied||Depression, Anxiety, Psychological problems, Low positive mental health|
|- Inclusion criteria||1. Age of 40 years and over;|
2. Presence of mild to moderate depressive symptoms.
|- Exclusion criteria||1. The presence of a DSM-IV major depressive disorder;|
2. A moderate to high suicide risk;
3. High level of anxiety symptoms;
4. The absence of depressive symptoms;
5. Being actively treated elsewhere with medication and/or psychotherapy.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2011|
|- planned closingdate||1-apr-2012|
|- Target number of participants||174|
|- Interventions||Integrative reminiscence: Course ("Op verhaal komen") of 10 weeks (self-help with counseling by e-mail) for people aged 40 years and older with mild to moderate depressive symptoms. "Storying one's life" is a course on autobiographical writing. Participants receive the book "Storying one's life". By themes as family, work and friendships the participants are invited to recollect memories from their lives. Specified questions on these memories lead to re-evaluation of their life stories.
Control group with minimal intervention: Expressive writing: Course ("Expressief schrijven") of 10 weeks (self-help with counseling by e-mail) for people aged 40 years and older with mild to moderate depressive symptoms. The minimal intervention focuses on expressive writing on past or current life events.
Control group waiting list: They do not receive a preventive course, but they do have infinite access to care as usual. This means that they are allowed to use all care they wish, which is emphasized in the information letter they receive. After the study, the control group waiting list is invited to participate in the course "Storying one's life".
|- Primary outcome||Reduction of depressive symptoms.|
|- Secondary outcome||1. Reduction of other psychological symptoms;|
2. Promotion of well-being.
|- Timepoints||1. Before the intervention (t0; baseline);|
2. Directly after the intervention (t1; 3 months after baseline);
3. 3 months after the intervention (t2; 6 months after baseline);
4. 9 months after the intervention (t3; 12 months after baseline).
1. Depressive symptoms (CES-D);
2. Major depressive disorder (MINI, by telephone);
3. Psychopathology (BSI);
4. Positive mental health (MHC-SF);
5. Growth motivation (Growth Motivation Index);
6. Narrative foreclosure (Narrative Foreclosure Scale);
7. Rumination (Ruminative Response Scale);
8. Ego integrity (Ego Integrity Scale).
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Sanne Lamers|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. E.T. Bohlmeijer|
|- Sponsor/Initiator ||University of Twente|
(Source(s) of Monetary or Material Support)
|University of Twente, Institute of Behavioural Science|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||24-feb-2011 - 6-mrt-2011|