The effects of Compassionate Mind Training on perceived stress, anxiety and depression in university students

ISRCTN ISRCTN13468533
DOI https://doi.org/10.1186/ISRCTN13468533
Secondary identifying numbers 1
Submission date
12/11/2022
Registration date
23/11/2022
Last edited
23/11/2022
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
University students report elevated levels of stress, anxiety and depression. Hence, it is important to study interventions that target stress and promote well-being in this group. The current study aimed to evaluate the effects of a five-week Compassionate Mind Training compared with a five-week affect-focused training in university students on measures of stress, anxiety, depression and self-compassion.
Compassionate Mind Training and affect-focused training are both psychological programs aiming to promote mental health. Compassionate Mind Training focuses on developing self-compassion, whereas affect-focused training primarily entails psychoeducation on affects (the outward display of emotional state).

Who can participate?
Students at university (studying a minimum of 75% of full-time)

What does the study involve?
Participants are randomly allocated to receive 5 weeks of either Compassionate Mind Training (intervention) or affect-focused training (active control). Compassionate Mind Training is closely based on pre-existing Compassionate Mind Training programs widely used in the UK and US. The intervention consists of psychoeducation on compassion and related concepts, as well as applied practice with different exercises. The active control group consists of an affect-focused training program. The program is based on a pre-existing Swedish affect group intervention. The intervention involves psychoeducation on primary affects and applied practice with different exercises.

What are the possible benefits and risks of participating?
A possible benefit for the participants is that they will learn new strategies to deal with stress. A risk with participating in a psychological intervention that includes self-reflection is that it might stir up emotions that can feel overwhelming to some. The interventions were, however, delivered by psychologists (licensed/in training) that were able to provide support when needed.

Where is the study run from?
Uppsala University (Sweden)

When is the study starting and how long is it expected to run for?
June 2013 to November 2015

Who is funding the study?
Skandia Advisory Board Research and Health (Sweden)

Who is the main contact?
Christina Andersson, christina.andersson@ki.se

Contact information

Miss Christina Andersson
Scientific

Strömsön 153
Arnäsvall
891 96
Sweden

ORCiD logoORCID ID 0000-0001-9076-0406
Phone +46 (0)702750898
Email christina.andersson@ki.se

Study information

Study designSingle-centre randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)School
Study typeTreatment
Participant information sheet See trial outputs table
Scientific titleThe effects of Compassionate Mind Training on perceived stress, anxiety and depression in university students – a randomized controlled trial
Study objectivesIt is hypothesized that the Compassionate Mind Training would have beneficial effects on perceived stress, anxiety, depression and self-compassion post-intervention compared with the active control group.
Ethics approval(s)Approved 06/11/2013, The Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02 Uppsala, Sweden; +46 (0)10 47508 00; registrator@etikprovning.se), ref: 2013/153231/3
Health condition(s) or problem(s) studiedStress in university students
InterventionParticipants are randomized in a 1:1 ratio using the online program random.org to receive 5 weeks of either Compassionate Mind Training (intervention) or affect-focused training (active control).

Compassionate Mind Training is closely based on pre-existing Compassionate Mind Training programs widely used in the UK and US. The intervention consists of psychoeducation on compassion and related concepts, as well as applied practice with different exercises. The active control group consists of an affect-focused training program. The program is based on a pre-existing Swedish affect group intervention. The intervention involves psychoeducation on primary affects and applied practice with different exercises.
Intervention typeBehavioural
Primary outcome measurePerceived stress measured using the Perceived Stress Scale (PSS14) (pre-and post) at baseline and after 5 weeks
Secondary outcome measures1. Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS) (pre-and post) at baseline and after 5 weeks
2. Self-compassion measured by the Self-Compassion Short-Scale (SC-SF) (pre-and post) at baseline and after 5 weeks
Overall study start date01/06/2013
Completion date19/11/2015

Eligibility

Participant type(s)Other
Age groupAdult
SexBoth
Target number of participants120
Total final enrolment59
Key inclusion criteriaStudying at a university (minimum 75% of full-time)
Key exclusion criteria1. Not fluent in Swedish
2. Over 15 score on HADS
Date of first enrolment16/09/2015
Date of final enrolment01/10/2015

Locations

Countries of recruitment

  • Sweden

Study participating centre

Uppsala University
Blåsenhus, Psychology Department
Von Kraemers allé 1
Uppsala
75105
Sweden

Sponsor information

Karolinska Institute
University/education

Institutionen för klinisk neurovetenskap
Stockholm
17176
Sweden

Phone +46 (0)70 4530546
Email walter.osika@ki.se
Website http://ki.se/en/startpage
ROR logo "ROR" https://ror.org/056d84691

Funders

Funder type

Industry

Skandia Advisory Board Research and Health

No information available

Results and Publications

Intention to publish date01/09/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe datasets generated and analysed during the current study are available upon request from Christina Andersson (christina.andersson@ki.se).
The type of data that will be shared: all existing data e.g. on item level
Whether consent from participants was required and obtained: Yes, informed consent was obtained.
Comments on data anonymization. Each participant was given a number so the participants were coded.
Any ethical or legal restrictions: No

Editorial Notes

23/11/2022: Trial's existence confirmed by the Swedish Ethical Review Authority.