DIVERS-II: Internet Intervention
Self-help Cognitive Behavioural Therapy for depressive symptoms in dialysis patients: a randomized controlled trial.

Depressive symptoms are highly prevalent in chronic dialysis patients, with a
prevalence of 43% in the Netherlands. Individuals with depressive symptoms have
an impaired quality of life, increased treatment non-adherence, increased
hospitalization and a considerably higher mortality risk. Despite the major
health problem of depression, it is often under-recognized and under-treated in
the dialysis population. To effectively treat depressive symptoms and improve
quality of life, more evidence is needed. A promising new development to
overcome several problems with intensive psychotherapy is the use of self-help
internet based Cognitive Behavioural Therapy (CBT). A widely used eHealth CBT
module has been tailored to the needs of dialysis patients. A robust randomised
trial with sufficient power could result in an easy accessible patient-friendly
treatment.

Primary objective:
To deliver an easy accessible, patient friendly and low-cost self-help
intervention for the treatment of depressive symptoms in dialysis patients.

Main hypothesis:
An eHealth CBT intervention reduces depressive symptoms in dialysis patients.

Objective:
1. To investigate the effectiveness of a self-help CBT in lowering depressive
symptoms and the associated adverse outcomes.
2. To examine the biochemical mechanisms involved in treating depression.

Relevance for renal patients and the scientific field:
This study is relevant for the renal scientific field for multiple reasons.
1. First, this study may deliver a nationwide accessible self-help intervention
which reduces depressive symptoms in chronic dialysis patients.
2. Second, this study can provide insight in the biochemical background and
interplay between the mind and the body. Associations from previous research
has only been investigated without treatment. This study provides an
opportunity to examine the effect of treatment on the associations found
between biochemical parameters and depressive symptoms. These results can be
relevant beyond the renal scientific field.
3. Third, this study examines the long term effects of an intervention measured
in psychosocial and clinical parameters such as hospitalization. Most studies
examining treatment of depressive symptoms in the chronically ill have a much
shorter follow-up period.
4. Lastly, This study combines data from the large DIVERS-cohort and a new
intervention study. This may lead to new insights in the development of
depression, subtyping different types of depression and in psychosocial and
pathophysiological reaction to treatment.
This study extends our knowledge of depressive symptoms in dialysis patients
and can serve as a base for future projects and research.

Study design:
This study is a parallel two-arm randomized trial comparing care as usual
versus an eHealth cognitive based therapy. Patients will be selected from 10
dialysis centres in Amsterdam and the Hague.

Intervention:
E-Health Problem Solving Therapy, duration of 5 weeks

Care-as-usual:
Care as usual as provided by nephrologist, social workers and if applicable
psychotherapists. This group will receive an online info-module about
depression in end-stage-renal-disease.

Duration:
The study will start in January 2017. Inclusion will end in 2018. Maximum
follow-up of an individual patient will be 18 months.
T0: Baseline (before randomization)
T1: Within 1-2 weeks after the intervention
T2: 6 months
T3: 12 months
T4: 18 months

The intervention consists of five modules with explanatory text, figures and
exercises. Patients are asked to examine 1 module per week and work on their
assignments for at least 2 hours per week. Patients will be asked to finish the
module within 6 weeks. However, there will be a possibility of extending this
period. This extension beyond 6 weeks will be documented. Patients can access
their intervention from several digital devices such as mobile phones, tablets
and personal computers. It works in every main browser available to date.

Supported care:
Within the module patients can ask questions to trained psychologist. They will
receive feedback from the same psychologists concerning their assignments.
Furthermore, they will receive a weekly e-mail to announce a new module.

Nurses & social workers:
Per center nurses and social workers will be trained in aiding the patients
using the intervention. They can explain the goals of the intervention, give
patients reminders to fill in their assignments and provide practical support.

Risks:
Patients will not be exposed to additional risks due to the treatment. Patients
and treating physicians are free to treat depressive symptoms to their best
intentions. No restrictions are given to the patients participating in this
trial. Suicidal thoughts will be screened in all participating patients.
Participants who indicate that they either intend to harm themselves or want to
attempt suicide will be excluded from this trial and referred to their
nephrologist. Patients who do not want to participate in this trial will
receive care-as-usual from their nephrologist.

Burden:
Personal: Completing the module and filling in questionnaires about depressive
symptoms could be confronting for some of the patients.
Time: Filling in questionnaires (5 x 30 min), completing the module (5 sessions
of 2 hours).
Blood samples: Will be taken prior to the dialysis session, no additional
puncture is needed for these samples.

Benefits:
An easy to use, patient friendly low intensive treatment to develop coping
skils to face their problems. Possibly improve depressive symptoms and quality
of life.

Relevance for renal patients and scientific field
This study is relevant for the renal scientific field for multiple reasons.
1. First, this study may deliver a nationwide accessible self-help intervention
which reduces depressive symptoms in chronic dialysis patients.
2. Second, this study can provide insight in the biochemical background and
interplay between the mind and the body. Associations from previous research
has only been investigated without treatment. This study provides an
opportunity to examine the effect of treatment on the associations found
between biochemical parameters and depressive symptoms. These results can be
relevant beyond the renal scientific field.
3. Third, this study examines the long term effects of an intervention measured
in psychosocial and clinical parameters such as hospitalization. Most studies
examining treatment of depressive symptoms in the chronically ill have a much
shorter follow-up period.
4. Lastly, This study combines data from the large DIVERS-cohort and a new
intervention study. This may lead to new insights in the development of
depression, subtyping different types of depression and in psychosocial and
pathophysiological reaction to treatment.
This study extends our knowledge of depressive symptoms in dialysis patients
and can serve as a base for future projects and research.