Effectiveness of acceptance and commitment therapy for students with psychological distress

ISRCTN ISRCTN11928453
DOI https://doi.org/10.1186/ISRCTN11928453
Secondary identifying numbers N/A
Submission date
19/09/2012
Registration date
11/12/2012
Last edited
11/12/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Martine Fledderus
Scientific

University of Twente
Drienerlolaan 5
Enschede
7522 NB
Netherlands

Phone +31 534896098
Email m.fledderus@utwente.nl

Study information

Study designA randomized controlled multi-centre trial with a waiting list as a control group
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffectiveness of acceptance and commitment therapy for students with psychological distress: evaluation in a randomized controlled trial
Study objectivesIt 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(s)Dutch Medical-Ethical Review Board for Mental Health Care Institutes (METIGG), 10 May 2011, ref: 11.122
Health condition(s) or problem(s) studiedDepression, anxiety
InterventionThe 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 typeOther
Primary outcome measureDepression (Center of Epidemiological Studies–Depression 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 measures1. 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 study start date01/09/2011
Completion date01/11/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants80
Key inclusion criteriaThe participants are students from the university with psychological distress (> 10 on the CES-D and > 3 on the HADS-A).
Key exclusion criteria1. 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)
Date of first enrolment01/09/2011
Date of final enrolment01/11/2012

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University of Twente
Enschede
7522 NB
Netherlands

Sponsor information

Fund NutsOhra (Netherlands)
Hospital/treatment centre

Amstelplein 6
Amsterdam
1096 BC
Netherlands

Email info@fondsnutsohra.nl
Website http://www.fondsnutsohra.nl/
ROR logo "ROR" https://ror.org/04ev7sy32

Funders

Funder type

Hospital/treatment centre

Fund NutsOhra (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan