The aim of the present study is to conduct a randomised controlled trial (RCT) to assess the effectiveness of a guided web-based transdiagnostic intervention in treating student depression and anxiety.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The endpoints of the RCT are the patient health questionnaire (PHQ-9) for
depression and the Generalised Anxiety Disorder - 7 items scale (GAD-7) for
anxiety. These scales will be administered at the screening (along with the
e-survey), post-treatment and follow-up assessments (6 and 12 months
post-randomisation).
Secondary outcome
The secondary endpoints are the Euroqol 5 Dimensions (EQ-5D) that will be
administered at baseline, 6 and 12 months post-randomisation and the Client
satisfaction with treatment * 8 items (CSQ-8) that will be administered at the
post-treatment.
Background summary
College years are considered to be a peak period for the first onset of common
mental disorders. Poor mental health is associated with physical, interpersonal
and cognitive impairments and low academic attainment. Universities can use
electronic media to screen for students with mental disorders but also to treat
those in need
Study objective
The aim of the present study is to conduct a randomised controlled trial (RCT)
to assess the effectiveness of a guided web-based transdiagnostic intervention
in treating student depression and anxiety.
Study design
The present study employs a RCT design.
Intervention
The intervention will be a guided web-based transdiagnostic intervention
targeted at symptoms of depression and/ or anxiety. The intervention consists
of 7 online sessions with duration ranging from 4 to 7 weeks depending on
individual progress. A booster session will be administered after the
completion of the 7th online session.
Study burden and risks
To our knowledge, there are no risks associated with the usage of the web-based
interventions.
Van der Boechorststraat 1 1
Amsterdam 1081 BT
NL
Van der Boechorststraat 1 1
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
* subject must meet all of the following criteria:
(a) participation in the niet-WMO study (2017.105) including consent to be contacted again for the RCT.
(b) Being 18 years of age or older
(c) Being enrolled as a student in a university or college in the Netherlands
(d) Speak Dutch or English fluently
(e) Students who experience mild to moderate depression (as defining by scoring above the cut-off score of 4 on the Patient health questionnaire [PhQ-9]) and/ or anxiety symptoms (as defining by scoring above the cut-off score of 4 on the Generalised Anxiety Disorder scale * 7 items [GAD * 7])
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in the RCT:
(a) Risk for suicide according to the self-report measure (e-survey)
(b) Co-morbid bipolar disorder according to the MINI diagnostic interview.
(c) Students with severe depression (as defining by scoring above the cut-off score of 14 on the PhQ-9) and/ or anxiety symptoms (as defining by scoring above the cut-off score of 14 on the GAD-7 scale).
(d) Currently receiving/ have received psychological treatment for depression and/or anxiety in the past 12 months
(e) Having slow or no Internet connection (e.g. no broadband Internet or something comparable)
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 | NL60156.029.16 |
| OMON | NL-OMON25368 |