Our aim is to develop JITAIs focused on behavioral activation (BA) for depression in close collaboration with patients and therapists, and to examine their usability, feasibility, and preliminary effectiveness.
ID
Source
Brief title
Condition
- Depressed mood disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
- No intervention
N.a.
Outcome measures
Primary outcome
<p>Primary outcome is the feasibolity of the JITAIs as an add-on in the<br />
psychological treatment of depression. </p>
Secondary outcome
<p>Secondaire outcome are: Patient Health Questionnaire (PHQ-9), Mental Health<br />
Continuum-Short Form (MHC-SF), Questionnaire about the Process of Recovery<br />
(QPR), Client-satisfaction questionnaire (CSQ-8), System Usability Scale (SUS),<br />
TWente Engagement with Ehealth Technologies Scale (TWEETS) and the EuroQol-5<br />
Dimension (EQ-5D). </p>
Background summary
Depression constitutes a significant public health issue, with rising
prevalence and a negative impact on quality of life, mortality, and morbidity.
Although psychological treatments*such as behavioral activation*are effective,
they are only effective for half of the participants. The effectiveness can be
improved by increasing adherence to activities between treatment sessions.
Promising for improving adherence are 'Just-In-Time Adaptive Interventions'
(JITAIs) that provide support 'at the right moment.' To date, JITAIs have not
been studied in the context of behavioral activation for depression.
Study objective
Our aim is to develop JITAIs focused on behavioral activation (BA) for
depression in close collaboration with patients and therapists, and to examine
their usability, feasibility, and preliminary effectiveness.
Study design
Qualitative research with focus groups (design phase), followed by a
quantitative quasi-experimental design in which JITAIs as an add-on to
treatment as usual are compared with the outcomes of treatment as usual
(evaluation phase).
Study burden and risks
Participants receive usual care throughout the study. The burden for
participants in the design phase consists of participation in focus groups, and
in the evaluation phase, it involves completing several questionnaires at 3
time points. If participants receive JITAIs as an add-on, the additional burden
consists of: daily measurements (4 times a day, with 12 - 17 questions) and
daily receipt of messages with a suggestion for a pleasant activity. There are
no potential risks for the subjects during participation in the study.
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
Healthy participants: Therapists working at Thubble and a patient representative
Patients: 1) age 18 years or older, 2) a diagnosis of a depressive disorder, and 3) in possession of an Android or iOS smartphone.
Exclusion criteria
1) Insufficient proficiency in the Dutch language
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
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 | NL87481.091.24 |
| Research portal | NL-005185 |