In the current protocol we describe 2 work packages in which we aim to perform: A. >=2 focus-groups to gauge acceptability of the smartphone-app (WP1); B. follow-up remitted patients with recurrent MDD for 1.5 year while the background app (…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A. Saturation of ideas obtained in the focus-groups;
B, E. SCID-+ve recurrences of depression during follow-up;
C, D. Changes in PASAT, Visual Probe and Recall/Evaluation task (RET)
performance
Secondary outcome
B, E. Changes in ESM-based symptom-networks;
C, D. Drop-out/noncompliance (<80% of training sessions) of CCT, ABM or
MBT-tasks; Change in rumination-scores; Change in executive neuropsychological
functioning; Changes in brain network-connectivity and associated parameters;
E. Association of change in PASAT/PVT/RET performance, negative biases and
executive functioning with future recurrences of depression during follow-up
Background summary
Despite high prevalence of MDD and 50-80% recurrence rate of Major Depressive
Disorder (MDD), recurrence prevention programs for MDD have limited efficacy.
This might be caused by the fact that 1. Impending recurrence is identified too
late and 2. Preventive strategies do not address underlying,
ethiopathophysiological risk-factors like cognitive reactivity, tendency to
ruminate, insufficient cognitive control over one*s thoughts and rumination or
negative attentional biases. The Smartphone based Monitoring and cognition
Modification Against Recurrence of Depression (SMARD) study (funded by the
Hersenstichting) will develop a second generation recurrence prevention
program, which will address 1. Earlier recognition by Smartphone application
measuring individual*s behavioural changes with a background app and occasional
intensive experience sampling method (ESM) data-collection with diaries 10
times/day for 6 days; and 2. Cognitive control training (CCT), Attentional Bias
Modification (ABM) training or Memory Bias Training (MBT) applied for 3 weeks
when patients with recurrent MDD (i.e. having a vulnerability to experience
recurrences) are in stable remission. We have the expectation that the total
SMARD second generation recurrence prevention program will reduce
recurrence-rates with 30%.
Study objective
In the current protocol we describe 2 work packages in which we aim to perform:
A. >=2 focus-groups to gauge acceptability of the smartphone-app (WP1);
B. follow-up remitted patients with recurrent MDD for 1.5 year while the
background app (BeHapp) is obtaining data, to start to develop algorithms to
identify impending recurrence, which will be cheked with a repetition of
ESM-data (WP1);
C. test the effects of smartphone based CCT, ABM and MBT training by a
smartphone app, in a sham-CCT/ABM/MBT training controlled randomised controlled
trial (WP2);
D. additional measurements (neuropsychology, MRI); and
E. successive follow-up over 1 year (WP2).
Primary objectives are:
A. to set up at least 2 focus groups (16-24 participants) to determine the
acceptability and/or need of modifications/explanation of BeHapp;
B. To gather BeHapp-data and ESM-data for 50-60 remitted patients with
recurrent MDD in association with follow-up data of prospective recurrences;
C. To validate three cognitive training modules (CCT, ABM and MBT) versus sham
training in 120 remitted patients with recurrent-MDD;
D. To assess the effects of CCT/ABM/MBT training to evoke changes in cognitive
dysfunctions (executive and emotional) and brain network function;
E. To gather BeHapp-data and ESM-data for 50-60 remitted patients with
recurrent MDD in association with follow-up data of prospective recurrences in
these patients treated with CCT/ABM/MBT or sham.
Study design
A. Focus groups;
B. Cohort-study;
C, D, E. Randomised controlled trial with secondary prospective follow-up
(cohort)
Intervention
A&B. none;
C, D, E. CCT (21 sessions of the Paced Auditory Serial Addition Task (PASAT);
1/day), sham CCT (21 sessions of the Peripheral Visual Training (PVT), ABM (42
sessions 2/day; positive bias training) or sham ABM (42 sessions 2/day; no
bias training), or MBT (21 days, 8 prompts/day; in 5x participants will be
asked to recall, evaluate and describe a recent positive event) or sham MBT (21
days, 8 prompts/day; in 5x participants will be asked to describe and evaluate
their current location).
Study burden and risks
Overall, the participation in the most intensive parts (C, D) consists of
undergoing neuropsychological and MRI test-sessions, a randomly assigned
CCT/ABM/MBT training during three weeks. During the follow-up (B, E), the
burden of the investigation is a 3-monthly telephone interview and in some
cases repeated ESM.
We consider the risk of moderate harm in this study to be low, while the risk
of low harm is expected to be low-moderate. Therefore, the overall risk
classification of this study is *negligible risk*.
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a patient must meet all of the following criteria:
- recurrent MDD diagnoses (assessed using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) (SCID) [First 1996])
- at least 3 previous MDD-episodes (as assessed with the SCID-interview)
- a 17-item Hamilton Depression Rating Scale (HDRS17) <=10 [Hamilton 1967], not fulfilling the criteria for a current MDD episode (as assessed with the SCID-interview)
- having a stable remission (>=8 weeks)
- age 18-65 years
- in possession of smartphone and experienced in use thereof
For the focus-groups in WP1, assessment of unipolarity, number of recurrences and non-depressed state will be assessed by history only (no SCID/HDRS17) as more thorough assessments are not proportional to the aim of the focus-groups.
Exclusion criteria
For both WPs:
- diagnosis of bipolar, primary psychotic or borderline personality disorder or strong suspicion of this type of disorder
- primary diagnosis of substance use or anxiety disorder with secondary MDD (comorbid secondary anxiety disorder allowed for participation)
- electroconvulsive therapy within two months before inclusion
- average alcohol intake of >3 units/day
- daily use of benzodiazepines (>=5mg diazepam or equivalent)
- Incompatible smartphone to install BeHapp ;Additional exclusion-criteria for WP2:
- ongoing psychotherapy during the CCT/ABM training
- previous CCT/ABM ;For the add-on MRI-part of WP2, standard MRI exclusion criteria will apply:
- Metal objects in the body
- Claustrophobia
- A history of head trauma or neurological disease, severe general physical illness
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60033.091.16 |