De stories we live.
A randomised controlled trial anex cost-effectiveness study.

Among elderly people, depression and anxiety are a significant health problem.
By far the most important risk factor of late-life depression or anxiety
disorder is the presence of depressive symptoms and/or anxiety symptoms.
Prevention has to constitute a main objective, in order to reduce the risk of
new onsets of anxiety and depression. International research indicates that
integrative reminiscence leads to a reduction in depressive symptoms and may
also be effective in reducing anxiety. Integrative reminiscence is a low
threshold intervention specifically developed for the elderly and directed at
an active re-evaluation of one*s life. In this project the (cost-)effectiveness
of the course 'The stories we live by', based on integrative reminscence, is
investigated. In this study the effects of the course on depression, anxiety,
quality of life and mental health are investigated by means of a randomized
controlled trial. In adition economic analyses will be conducted.

Hypothesis:
The intervention is superior compared to the "no prevention" comparison
condition in clinical outcome measures (reduction in anxiety and depressive
symptoms and improvement in quality of life and psychological health) and
cost-effectiveness.

Goals of the proposed study are to empircally test the course 'The stories we
live by" on:
1. The effectiveness in reduction of depressieve and axiety symptoms;
2. The effectiveness in improvement of quality of life and psychological health;
3. The prognostic (moderating) factors that predict succes or failure in
symptom reduction (reminiscence style, personality,
sexe, initial symptom levels of depression and anxiety);
4. De presence or absence of mastery, sense of meaning, negative thinking as
mediating factors;
5. The cost-effectiveness, or incremental costs, by avoided "possible cases";
6. The cost-utility, or incremental costs, by quality adjusted life year
(QALY).

The design of the study is a randomized controlled trial with two parallel
groups. First there is the experimental condition, attending 'The stories we
live by'. Second there is the "no-prevention" comparison condition with open
access to care-as-usual , in which participants can use all care they wish.
This is a pragmatic, non-blind multi-site trial.

The course 'The stories we live by' is offered twice by every participating
mental health prevention department. This is a group specific intervention with
a maximum of four participants, that consists of seven sessions of 2 hours and
one follow-up session after eight weeks. In this intervention participants are
invited to recall memories of their own life by means of different topics:
youth and family, work and care, love and friendship, difficult times, life as
a book with chapters, metaphors, meaning in life. Participants are given
questions about these topics which they have to answer at home. Through
specific questioning an active (re-)evaluation of one's own life story takes
place.

The people that do not follow the course are compared to the comparison group.
The do not recieve a preventive course, but they do have an infinite acess to
care as asual. This means that they are allowed to use all care they wish, wich
is named with emphasis in the information letter they receive. After the study
the comparison group is still invited to participate in the course.

Burden associated with the intervention:
Participants of the course "The stories we live by" receive 1
intake-conversation (30 minutes), 7 course meetings and 1 follow-up meeting
(all 2 hours). In being able to follow the course there is travelling involved.
De participants in the control group receive no intervention. After the
research however, they are still offered to follow the course "the stories we
live by".

Burden associated with the study:
Participants of this study have to fill out questionnaires at four different
measure moments; before the intervention, 4 weeks after the start of the
intervention, directly after the intervention and 6 months after the
intervention. The first questionnaire is somewhat larger than the other
questionnaires and will take approximately 60 minutes. Filling in the other
questionnaires will take approximately 30-45 minutes by measure moment (for the
questionnaires to use see pp. 7 and 8 of the protocol).

Aditional estimation of the risks:
We do not expect any risks for the participants involved. After all:
1. Participants participate out of own movement because they suffer from light
to moderate depressive complaints and/or anxiety complaints. The possibly
positive result of diagnostic study into the possible presence of a depressive
impairment cannot come as a complete surprise. In other words, the test person
is not faced then with an incriminating fact new for him or and.
2. The intervention is consequently presented at any time as a possibility more
of getting grip on one's life. In the course there is a focus on bringing forth
memories and life-stories that empower the participant.