The primary aim of this study is to compare adherence rates between (1) people who receive a short course aimed at improving mood with automated support by a virtual coach, (2) people who receive the same course with personalized supportive messages…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is adherence, measured as intervention completion,
and number of mood registrations.
Secondary outcome
Secondary outcome measures are motivation (motivation for following the course
and motivation to continue using the course), the relationship with the virtual
coach (acceptance of the virtual coach and working alliance), and feasibility
(system usability, user satisfaction, mood ratings, mental health status, and
performed activities).
Background summary
Online interventions for common mental health disorders such as depression are
considered effective. Guided interventions, however, are typically more
effective than unguided ones, and show better adherence rates. Automated
support by a virtual coach or personalized supportive messages could help
bridge the gap between guided and unguided interventions.
Study objective
The primary aim of this study is to compare adherence rates between (1) people
who receive a short course aimed at improving mood with automated support by a
virtual coach, (2) people who receive the same course with personalized
supportive messages and (3) people who receive the same course without
automated support. Secondary aims are to evaluate the participants* motivation
to follow and keep following the intervention, their acceptance of and
relationship with the virtual coach (intervention group with the virtual coach
only), and the system*s feasibility in terms of usability, user satisfaction,
and symptom improvement.
Study design
The study follows a three-armed pilot randomized controlled trial design. There
are two measurement points: T0 (baseline), and T1 (end of study, 4 weeks after
T0).
Intervention
Moodbuster Lite is a four-week online self-help course based on cognitive
behavioral therapy that consists of three lessons and a smartphone application
used to keep track of one's mood. The intervention group will also receive
automated support by a virtual coach or by means of personalized supportive
messages. The core elements of the course are motivational interviewing (lesson
one), psychoeducation (lesson two), and behavioural activation (lesson three).
Study burden and risks
Participant burden involves completing online questionnaires at baseline and
after four weeks. The risks involved in taking part in the study are considered
minimal. Participants in all three conditions may benefit from taking part in
the intervention by acquiring skills to improve their mood. Completion of the
questionnaires may be slightly distressing for some participants.
V.d. Boechorststraat 7-9
Amsterdam 1081 BT
NL
V.d. Boechorststraat 7-9
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
1. Aged 18 years or older
2. Self-reported desire to improve one*s mood
Exclusion criteria
1. Not willing to sign the informed consent form
2. No adequate written proficiency in the Dutch language
3. No valid e-mail address or a computer with internet access
4. Does not possess a smartphone
5. A score of 15 or higher on the PHQ-9 (indicating moderate to severe levels
of depression that warrant more serious treatment)
6. A score of 1 or higher on item 9 of the PHQ-9, indicating that this
participant thought of suicide at least several times during the past two
weeks.
Design
Recruitment
Medical products/devices used
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 | NL69433.029.19 |