The objective is to investigate the effectiveness of an Internet-based self-help intervention for people with mild symptoms of anxiety and/or depression. This intervention will be offered with and without guidance and will be compared to usual care…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
angstsymptomen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary ouctome is disorder specific symptom severity at post-intervention.
This will be assessed by the QIDS for depression and the HAM-A for anxiety.
Secondary outcome
Secondary endpoints include:
* CMHD onset within 6 and 12 months follow-up (outcome)
* CMHD free days (outcome)
* Costs (outcome)
* Health related quality of life (outcome)
* Self-esteem (moderator)
* Motivation (mediator)
* Program evaluation (mediator)
* Wellbeing (outcome)
* Alcohol use (outcome)
* Socioeconomic/demographic characteristics (moderators)
* Risk factors (optional, moderators)
* Negative effects of treatment (outcome)
* Sleep quality (outcome)
* Worry (outcome)
* Emotion regulation (outcome)
* Incongruence (outcome)
* Personality (moderator)
* Supporting accountability (mediator)
* Resilience (moderator)
* Treatment satisfaction (mediator)
* Behavioural activation (outcome)
Background summary
Depression and anxiety are common mental health disorders. Interventions that
target mild complaints could treat and prevent the development of these
conditions. The internet offers the possibility of following such an
intervention independently with minimal guidance. ICare Prevent is a
transdiagnostic Internet intervention that aims at the treatment and prevention
of anxiety and depression. Research indicates that anxiety and depression share
common underlying factors, a transdiagnostic approach is therefore particularly
appropriate in this context. Since there is still insufficient evidence on the
additional value of support by means of a coach, and on the cost-effectiveness
of Internet interventions, these factors will be investigated more closely in
this study.
Study objective
The objective is to investigate the effectiveness of an Internet-based
self-help intervention for people with mild symptoms of anxiety and/or
depression. This intervention will be offered with and without guidance and
will be compared to usual care (treatment as usual: TAU). Moreover, the
cost-effectiveness of the intervention will be determined. In addition,
moderators and mediators of adherence and effectiveness will be investigated.
Study design
This study is a randomized controlled trial with three arms: 1) unguided
intervention group, 2) (minimally) guided intervention group, 3) control group
(TAU). Treatment allocation is blinded. It is not possible to blind either
participants or eCoaches. Outcome assessors who will conduct the interviews
will be blinded. Participants have a 1:1:1 chance to be randomized into either
one of the three conditions.
Intervention
ICare Prevent is an Internet-based intervention using evidence-based cognitive
behavioral therapy (CBT) principles. The intervention consists of 7 main
sessions and 1 booster session (activated 4 weeks after session 7). In sessions
5 and 6 participants choose whether they would like to learn more
problem-solving techniques (for more prominent depressive complaints) or engage
in exposure (for more prominent anxiety complaints). In sessions 2-7
participants can decide to add either one of 9 choice modules (sleep,
perfectionism, self-esteem, alcohol consumption, gratitude/appreciation,
acceptance, rumination, relaxation, worry confrontation). Participants in the
guided intervention group receive support by an eCoach. This coach provides
feedback on the exercises. Participants in the unguided intervention group
receive short motivational messages.
Study burden and risks
No known risks. Participants may expierence answering the questionnaires and
interviews as a burden.
Van der Boechorstraat 1
Amsterdam 1081BT
NL
Van der Boechorstraat 1
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
1) age * 16 years
2) experience mild self-reported symptoms of depression (CES-D between 16 and 28) and/or anxiety (GAD-7 between 5 and 14)
Exclusion criteria
1) being on a waitlist for, currently receiving, or having received psychotherapy within the past 12 months for any mental health condition
2) having a lifetime bipolar or psychotic disorder (assessed by M.I.N.I.)
3) being at moderate-high suicide risk (M.I.N.I.)
4) self-reported inability to read or write Dutch or English
5) No access to the Internet
6) no informed consent
7) participation in similar studies at time of inclusion
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL60705.029.17 |
| OMON | NL-OMON27825 |