Plain English Summary
Background and study aims:
Many students suffer from psychological distress and most of them do not seek help. The objective of the study was to investigate the effects of the group course, called Getting more out of your life" for college students with psychological distress. The secondary objective of the study is to evaluate the effectiveness of this course on positive mental health, mindfulness, and psychological flexibility.
Who can participate?
Students with mild to moderate anxiety and/or depression symptoms, male or female aged over 17 years.
What does the study involve?
The participants were randomly allocated to one of the following groups:
1. Experimental condition: the group course "Getting more out of your life". The course is provided by universities and a mental health institution.
2. Control condition: The participants are on a waiting list for three months. After the waiting period they receive the same group course as the experimental condition.
What are the possible benefits and risks of participating?
Participants may benefit by an improvement in their mental health. We do not expect many risks associated with participation and no side effects. Participants are allowed to seek for help elsewhere and they can stop all times with the study and/or group course.
Where is the study run from?
University of Twente (Lead Centre)
Saxion University Deventer
Saxion University Enschede
University Zeeland
Indigo Nijmegen
When is study starting and how long is it expected to run for?
The study is started in September 2011 and ended in November 2012. Participants were recruited for one month.
Who is funding the study?
Fund NutsOhra, The Netherlands
Who is the main contact?
Dr. Martine Fledderus
m.fledderus@utwente.nl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Martine Fledderus
ORCID ID
Contact details
University of Twente
Drienerlolaan 5
Enschede
7522 NB
Netherlands
+31 534896098
m.fledderus@utwente.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effectiveness of acceptance and commitment therapy for students with psychological distress: evaluation in a randomized controlled trial
Acronym
Study hypothesis
It is hypothesised that the group-course based on acceptance and commitment therapy for students shows superior effects in reducing depressive symptoms, anxiety symptoms and in increasing psychological flexibility, mindfulness and positive mental health compared to a waiting list.
Ethics approval
Dutch Medical-Ethical Review Board for Mental Health Care Institutes (METIGG), 10 May 2011, ref: 11.122
Study design
A randomized controlled multi-centre trial with a waiting list as a control group
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Depression, anxiety
Intervention
The intervention is called Getting more out of your life and is based on ACT and augmented with mindfulness exercises. The intervention consists of four three-hour group-sessions. The first three sessions are weekly and there are two weeks between the third and last session, in total the intervention lasts for five weeks. The intervention is provided by clinical therapists with ample experience in ACT and mindfulness.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Depression (Center of Epidemiological StudiesDepression Scale) is assessed at basline, five weeks after baseline, 3 months after baseline and, 9 months after baseline (only experimental group), and 12 months after baseline (only control group).
Secondary outcome measures
1. Anxiety (Hospital Anxiety and Depression Scale-Anxiety subscale), psychological flexibility (AAQ-II)
2. Mindfulness (FFMQ-SF)
3. Positive mental health (Mental Health Continuum- Short Form ) are assessed at basline, five weeks after baseline, 3 months after baseline and, 9 months after baseline (only experimental group), and 12 months after baseline (only control group).
Overall trial start date
01/09/2011
Overall trial end date
01/11/2012
Reason abandoned
Eligibility
Participant inclusion criteria
The participants are students from the university with psychological distress (> 10 on the CES-D and > 3 on the HADS-A).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. The presence of a mood disorder according to the Mini International Neuropsychiatric Interview (MINI)-PLUS. People with severe mood disorder are refered to the general practitioner
2. The presence of mild to high suicide risk according to the MINI-Plus
3. No psychological distress (< 10 on the CES-D or < 3 on the HADS-A)
4. Started three months ago with medication for psychological distress
5. Receiving an treatment for psychological distress
6. Trouble with the Dutch language (reading or learning difficulties)
Recruitment start date
01/09/2011
Recruitment end date
01/11/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
University of Twente
Enschede
7522 NB
Netherlands
Sponsor information
Organisation
Fund NutsOhra (Netherlands)
Sponsor details
Amstelplein 6
Amsterdam
1096 BC
Netherlands
info@fondsnutsohra.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Fund NutsOhra (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary