Grip op je dip online (Master your mood online): development and effectiveness

An estimated 80,000 Dutch young people aged 18 to 25 suffer from depression
every year (NEMESIS
study, Trimbos Institute, 2005). One out of every five young people are
believed to experience
depressive symptoms which have not yet culminated in full-blown depression
(study by J. Kramer,
Trimbos Institute, of 4443 secondary school pupils, 2001; Monck et al., 1994).
In addition to the
suffering that these conditions cause, early depression can be detrimental to
the educational and
working careers. There are also economic consequences for society. Given the
nature and extent of this
problem, there is much to be gained by nipping depression in the bud.

Subclinical symptoms are promising targets for intervention. Often they are
omens of full-blown
depression (Cuijpers, 1998). Subclinical symptoms are influenceable, and
appropriate intervention can
avert depression (Cuijpers et al., 2004 a/b; Clarke et al., 1995, 2001; Smit et
al., 2003). Insights like
these prompted us several years ago to develop the face-to-face Grip op Je Dip
prevention course for
young people aged 16 to 25 with depressive symptoms. It is based on the Coping
with Depression
Course which has been shown effective (Lewinsohn & Clarke, 1984; Clarke et al.,
1995, 2001).
The face-to-face course did not sufficiently reach the target group. Young
people found it too
inaccessible, and that resulted in low uptake, longer waiting periods for the
start of courses. At the same
time, there has been a rush on youth mental health websites like
www.zwaarweer.nl from the Korrelatie
Foundation (Teunis, 2001). Korrelatie have indicated that many such young
people need types of help
that they are unable to offer. For this reason, the Trimbos Institute joined
with Korrelatie and three Dutch
regional mental health agencies in a new pilot project (November 2003-July
2005). The objective was to
adapt the Grip op Je Dip face-to-face course for online delivery, and then
perform a pilot study to test it
in practice on young people aged 16 to 25 with depressive symptoms. The course
consisted of eight
weekly 90-minute sessions. Small groups of up to six participants were given
the course, supervised by
two mental health care professionals in a secure chatroom with various
functionalities.

The results of the pilot study were very promising (van der Zanden et al.,
2005). Young people were
easily reached, and many expressed interest (249 during two 4-week recruitment;
see table 1), resulting
in rapid take-up and short waits. The anonymity of the course was highly
valued, and depressive
symptoms according to the CES-D were reduced - from an average of 34.5 (sd=8.5)
at baseline to 16.3
(sd=7.5) after the course (see table 2).

The pilot study also brought to light certain issues that now require further
development and research.
The issues are as follows:
a) Course adherence. Adherence was greater in the first half of the course than
in the second half. Two thirds of the participants took part in four or more
sessions, but only one fifth completed all sessions (unfortunately no
comparative adherence data is available on the face-to-face course). Because
the specific course topics were dispersed over the eight sessions, certain
essential information did not get through to all participants. Lack of exposure
and drop-out to online interventions is a well-known issue (de Nooijer et al.,
2005; Emmelkamp, 2005; Riper et al, in press). By adapting the
course, we hope to ensure that participants will receive all the necessary
information and are able to put
it to use. For that purpose, we are developing a shorter variant of the course
which will consist of five
sessions containing the essential information (see Strategy: 'Long versus short
course variant').

b) Severity of the mental health problems. Most young people who applied for
the pilot course had rather
high symptom levels on the CES-D; the mean score was 34.5 (sd=8.5). Many of them
could have probably been diagnosed with a depressive disorder. Young people
with lower levels of
symptoms were in the minority, whereas they were the group we were also
targeting in this prevention
course. The study we are now proposing will investigate whether recruitment
through channels other
than Korrelatie will result in higher enrolments of people with milder
symptoms. To avoid participation by
people with more severe depression problems, we will screen them out by
administering the MINI Plus
online and then refer them to appropriate mental health care providers. The
MINI Plus is a structured
diagnostic interview for assessing DSM-IV mental disorders.

As this E-mental health project (a) could greatly facilitate the reaching of
high-risk groups and (b) could
serve as a model for other prevention group services in the mental health
sector, we feel it is more than
worthwhile to develop it further and test the effectiveness. That is the
purpose of this grant application.

The aim of the project is to further develop and study the effectiveness of the
Internet groupcourse Grip
op Je Dip Online for young people (16-25 years) with depressive symptoms.

Development objective:
The eight-session groupcourse will be adapted into a shorter course of five
weekly 90-minute sessions.
The shorter course is to deliver all the essential information within a more
compact time frame, enabling
as many participants as possible to benefit before the dropout rate increases.
The shorter course
focusses on CBT-principles and encouragement of pleasurable activities.
The recruitment procedure will also be optimised. Our goal is to reach more
young people with lower
levels of depressive symptoms, by recruiting on a broader scale. We will also
test the online MINI Plus
diagnostic instrument.

Research objective:
The aim of the research study that parallels the course will be to study the
effectiveness of the course
and to identify groups that seem to derive the most and least benefit from the
online course in terms of
depressive symptoms (which individual characteristics such as education,
motivation predict the
symptom levels after the course and hence identify the most appropriate target
groups).
Another aim is to ascertain whether young people with milder levels of symptoms
can be sufficiently
recruited and, if so, through which channels.

DESIGN
After adaptation of the course a randomized controlled trial with two parallel
groups is conducted: the
experimental course *Grip op je dip* vs. a control waiting list.

ASSESSMENTS
Assessments will be made at:
- T0 before randomization
- T1 3 months after T0 (for the experimental group this will be short after the
last session)
- T2 6 months after T0.
Participants receive a bonus of 12,50 euro for completing questionnaires at T1
and T2.

NUMBER OF STUDY PARTICIPANTS / POWER
Ten Dutch mental health care agencies have committed themselves to conducting
the online course four
different times for six participants. This means that a maximum of 10x4x6=240
participants can be
recruited for the study. N=120 per condition is more than sufficient to have
enough power (1-bèta=0.80)
in a onesided test of alpha=0.05 (we expect a better outcome of the course
compared to the waiting list
control group) to detect a reduction in depressive symptoms of d=0.33 as
significant in the analysis.
(Stats syntax: sampsi 0.00 0.33, sd1(1) sd2(1) power(0.80) onesided). These
numbers also give sufficient statistical possibilities for the prediction of
the most appropriate target group. Stevens (1996) argues that, in order to
obtain a sufficient basis for generalising the results, 15 respondents are
needed for every predictor variable in a regression equation. Tabachnick and
Fidell (1996) prescribe 104 respondents plus one additional respondent for each
predictor variable. As we will include a maximum of 8 predictors, we thus need
a total of 120 participants according to Stevens and 112 participants according
to Tabachnick and Fidell.

STATISTICAL ANALYSIS
Analyses will be conducted by using Stata (version 9.0) and SPSS (version 14.0)
To identify predictors of clinical outcomes we will perform OLS regressions. To
define the outcomes in a
normative context based on clinical notions such as *improved*, *unchanged* or
*worsened*, we will
express the depressive symptoms, anxiety and mastery as standardised effect
sizes (Cohen*s d). The
classification of effect sizes proposed by Lipsey and Wilson (1993) will then
provide an indication of the
clinical significance of the change. Effect sizes of d=0.32 or higher indicate
clinically relevant change,
d-values in the 0.32 to -0.32 range indicate no change, and values lower than
0.32 show negative
change (clinical worsening). This will enable us to differentiate groups that
benefited from the
intervention from those that did not. We will then perform logistic regression
analysis to identify
predictors of the success or failure of the intervention.
Analyses with regard to effectiveness. These analyses will be based on the
intention-to-treat principle.
Missing values at T1 and T2 data will be imputed using either the
last-observation-carried-forward
principle or a more advanced method (regression imputation or multiple
imputation, both as
implemented in Stata). At T2 the conditions will both have finished the course.
This means that T2 data
will not be used to answer the *effeciveness* question, but that it will be
used to study effect preservation
at the longer term (for the experimental group) and to study what the outcomes
are for the waiting list
condition after finishing the course.

TIME PLAN
Preparation (8 months); Execution (22 months); Data analysis and reporting and
adaptation of the Grip
op Je Dip Online course manual (6 months).

THE ONLINE INTERVENTION
The online course is based on cognitive-behavioural therapy (CBT), social
skills training and
encouragement of pleasurable activities. The shortened version of the course
will have five weekly
90-minute basic sessions. This shortened variant will incorporate the essential
elements of the course
(CBT-principles and the encouragement of pleasurable activities). The
development of this shortened
variant is part of this research proposal. The control intervention is a
waiting list control group. The
waiting period is three months.

THE LONG VERSUS SHORT COURSE VARIANT: A COMPARISON
In the original course 5 of the 8 sessions are aimed at the change of behavior,
thoughts and feelings and
the encouragement of pleasurable activities. Two sessions aim at enhancing
one*s assertiveness and
how to manage conflicts. In the last session the accent lays at how the
participant can deal with future
signals of depressed feelings. The original course has the same construction as
the face to face Grip op
je dip course (Voordouw e.a., 2001; Van der Zanden e.a., 2006).
The proposed adapted course will consist 5 sessions. The content of these 5
sessions will be derived
from the first 5 and the last session of the original course. On base of
experiences of the course leaders
and the feedback of course participants of past courses, the sessions will be
slightly adapted.

BURDEN ASSOCIATED WITH THE ONLINE COURSE. the online course contains 5 sessions
(90 minutes each). Potential participants complete the Center for
Epidemiological Studies Depression Scale (CES-D) to assess the severity of
their depressive symptoms. Applicants with CES-D scores between 10 and 24 will
be admitted to the course; between 24 and 45 will be administered the online
MINI Plus (international neuropsychiatric interview) in the chatroom to rule
out the presence of severe psychiatric symptoms. We expect that the MINI Plus
will be administered in 60 % of the participants. All participants are
contacted by e-mail by their course instructor preceding the course.

BURDEN ASSOCIATED WITH THE STUDY. Participants complete a questionaire at three
points in time: preceding the course; three months after baseline and six
months after baseline. Completing each measurement will take up to 30 minutes
(In total 90 minutes for the entire study).

RISKS: We expect no risks for the respondents because:
The particiapants apply voluntary to the course since they have depressive
symptoms.
The intervention concerns a course and not a treatment or therapy.
a screening is taken place: adolescents with suicidality or psychosis will be
carefully referred.