The Effects of a Self-compassion Therapist-led Online Group Treatment for Adolescents With Distress, Anxiety and Depression
Phase: NA
Conditions: Distress, Emotional, Anxiety, Depression
Sponsor: Umeå University

 
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Study Protocol  
 
Unique Protocol ID: EtikDnr2021-04357CUST1 
Brief Title: Self-compassion Therapist-led Online Group Treatment for Adolescents With 
Distress, Anxiety, and Depression ( CUST ) 
Official Title: The Effects of a Self-compassion Therapist-led Online Group Treatment for 
Adolescents With Distress, Anxiety and Depression 
NCT number: 05448014 
Document date: 1 July 2022 
 
Study description 
Brief Summary:  
Background: Distress, anxiety and depression are highly prevalent in school health care or 
primary care. Many of these conditions remain undiscovered and/or untreated. Compassion-
focused therapy (CFT) is effective in the treatment of adults’ distress and depression, and the 
investigators will now evaluate the preliminary effect of a brief therapist-led online group 
CFT, feasibility, and acceptability in low-threshold distressed, anxious, and depressed 
adolescents. The investigators use online group CFT to increase availability. 
Purpose: The purpose of this study is to determine whether therapist-led online group CFT is 
feasible and acceptable for the treatment of depression in adolescents between 15 and 20 
years of age, in Sweden. The preliminary effect will be calculated to examine if a larger 
experimental randomized controlled trial is justified. 
Study design: A two-arm (treatment group vs. control group) pilot randomized controlled trial 
will be carried out with 32 adolescents. The effect, feasibility, and acceptability of the 
therapist-led online CFT in groups will be evaluated. 
Condition or disease: Distress, anxiety and depression  
Intervention/treatment: Other: therapist-led online group compassion focused therapy; 
Other: Usual care treatment 
Phase: Not applicable 
Arms and Interventions 
Experimental: therapist-led online CFT in groups 
Seven sessions of therapist-led online compassion-focused therapy in groups of 4-8 
adolescents with mild to moderate symptoms of distress, anxiety, or depression. Trained 
therapists administer the CFT program in face-to-face meetings. 
Passive Comparator: Waitlist 

 
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Intervention/treatment 
Other: Therapist-led online compassion-focused therapy in groups. 
The intervention arm will receive seven sessions of therapist-led online CFT in groups. 
Internet-delivered CFT sessions 1,5h, will be delivered on a weekly basis and assisted by 
trained psychologists or psychotherapists in face-to-face meetings. The program is called 
“Compassion focused training for adolescents with stress”. Topics covered in the program 
will include 1) what is compassion, 2) understanding myself, 3) life-compass, 4) self-
compassion and my body, 5) feelings and compassion, 6) creating balanced thoughts, and 7) 
imagination. 
Other: The waitlist control group will receive training after being on the waiting list but is 
not included in the main analyses. The result from this will be compared with the result of the 
RCT pilot study afterwards. 
Primary outcome measure:  
1. 
The total score of Perceived Stress Scale, 
14 items, 0 = never to 4 = very often 
Higher scores mean a worse outcome 
 
2 
The subscale Depression in Trauma Symptom Checklist for Children (TSCC), 9 
item, 0 = never to 3 = almost always 
Higher scores mean a worse outcome 
 
3. 
The subscale Anxiety in Trauma Symptom Checklist for Children (TSCC) 
9 item, 0 = never to 3 = almost always 
Higher scores mean a worse outcome 
 
Feasibility: Drop-out rates and adherence 
Acceptability: Self-report evaluations questions in a form and semi-structured focus 
interviews will be performed. 
 
Secondary outcome measures: 
1. 
The Compassionate Engagement and Action Scale for Adolescents (CEASY). 
27 items, 1 = never to 10 = always 
Higher scores mean a better outcome 
 
2 
The subscale PTSD in Trauma Symptom Checklist for Children (TSCC), 9 item, 0 = 
never to 3 = almost always 
Higher scores mean a worse outcome 
 

 
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3. 
The subscale Dissociation in Trauma Symptom Checklist for Children (TSCC) 
9 item, 0 = never to 3 = almost always 
Higher scores mean a worse outcome 
4. 
The subscale Anger in Trauma Symptom Checklist for Children (TSCC) 
9 item, 0 = never to 3 = almost always 
Higher scores mean a worse outcome 
5. 
The Montgomery and Åsberg Depression Rating Scale for Youths (MADRS-Y) 
12 item, 0 = never/normative in sentences to 6 = always/described pathology in 
sentences 
Higher scores mean a worse outcome 
6. 
The WHO-5 wellbeing index (WHO-5) 
5 item, 0 = never to 5 = all the time 
Higher scores mean a better outcome 
7. 
The Difficulties in Emotion Regulation Scale (DERS) 
16 item, 1 = almost never to 5 = almost always 
Higher scores mean a worse outcome 
8. 
The Situational Motivation Scale (SIMS) 
16 item, 1 = corresponds not at all to 7 = corresponds exactly 
Higher scores mean a better outcome 
9. 
The Intrinsic and Extrinsic Motivation Scale (IEMS) 
16 item, 1 = corresponds not at all to 5 = corresponds exactly 
Higher scores mean a better outcome 
 
 
Eligibility Criteria 
Ages Eligible for Study: 15 Years to 20 Years (Child, Adult) 
Sexes Eligible for Study: All 
Accepts Healthy Volunteers: No 
Criteria 
Inclusion Criteria:  
• Symptoms of distress (≥ 22 in PSS) and/or 
• Symptoms of anxiety (≥ 9 in subscale Anxiety in TSCC) and/or 
• Symptoms of depression (≥ 10 in subscale Depression in TSCC)  
• Adolescent giving informed consent  
• Caregiver giving informed consent if needed 
• Speaking Swedish 
• Able to read and fill forms in Swedish without troubles 
• At least one close and stable relationship with an adult 
• Able to be in a group on the internet 

 
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Exclusion Criteria:  
• Severe psychological problems that can be hindering for participation in a group 
treatment 
• No close stable relationship with an adult 
• Suicidal risk (4 or higher in item 12 in MADRS-Y, together with a clinical decision of 
active suicidal plans during the diagnostic screening interview) 
• Anorexia Nervosa 
• Autism 
• Bipolar Disorder 
• Current substance and alcohol dependence 
• Current psychosis 
• Current active psychotherapy  
• Current deposit or withdrawal of antidepressant 
• Prescribed medications for anxiety or depressive disorders do not exclude participants 
from the study, if the dosage had remained constant for at least one month. 
 
Detailed Description: 
Compassion focused therapy for depressed adolescents (CUST) 
Introduction 
Adolescence is a vulnerable period of growth and challenges, characterized by rapid 
physiological and emotional changes. All these changes happen at the same time as 
relationships expand. A developing self together with a pressure to “fit in” can lead to self-
critic and distress. Without appropriate coping skills to manage these challenges, adolescents 
are more vulnerable to psychological problems. Distress, anxiety, and depression have also 
increased in the western world during the last years, and especially girls or young women are 
affected (WHO, 2019). In addition, depressive disorders are the single largest contributor to 
global disability (WHO, 2017). Adolescents-appropriate training in compassion may help 
adolescents successfully overcome the challenges in the future and help adolescents to take 
care of themselves. 
Schools are not just about acquiring knowledge, they are playing a central role in cultivating 
necessary social, emotional, and ethical skills required to lead successful lives (Jazaieri, 
2018). Recently, there has been a great interest in bringing mindfulness and compassion to 
educators and students.  
The construct of compassion is defined by Paul Gilbert as a “sensitivity to suffering in self 
and others with a commitment to try to alleviate and prevent it” (Gilbert, 2014) and include 
compassion for oneself, compassion for others, and receiving compassion from others. 
Compassion strategies are core competencies in life, already taught by large religions as 
Christianity and Buddhism, but now in a modern version along with new neurobiological 

 
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research and cognitive behavior therapy interventions. These skills or strategies can be taught, 
but have not yet been widely used in the contexts of adolescents (Jazaieri, 2018).  
Research supporting compassion focused therapy for depression 
Compassion focused therapy (CFT) was developed two decades ago and is a well-established 
talking therapy for depression and stress (Gilbert, 2007). Compassion has a protective effect 
against depression and suicidality (Zeller et al., 2015), in youth. Training in compassion is 
linked to well-being and perceived life satisfaction (Kirby et al., 2017). Meta-analytic findings 
of CFT on adults has recently showed moderate effects on stress, depression and anxiety (Kirby 
et al., 2017). Studies with adolescents are few. For example one small study (Bluth et al., 2016) 
with 34 14-17 year old students found that a mindful self-compassion school program in six 
weeks was feasible and acceptable. The intervention group had significantly greater self-
compassion and less depression than the waitlist control.  
 
The CFT intervention 
Compassion Focused Training (CFT). The investigators have developed a new manual for 
CFT training with seven modules (Dennhag, 2021) including 1) what is compassion, 2) 
understanding myself, 3) life-compass, 4) self-compassion and my body, 5) feelings and 
compassion, 6) create balanced thoughts, and 7) imagination. CFT is an internet-delivered 
(zoom or teams) real time group training (for 15-20 years old adolescents), 1,5h, in seven 
weeks. The youth will receive a manual for practice. The investigators were inspired by 
Professor Paul Gilbert, Mary Welford, and Elaine Beaumont’s approach (Welford & 
Beaumont, 2020), but the investigators have shortened and adapted Welford and Beaumont 
manual to Swedish context. In addition, the investigators are influenced by cognitive behavior 
principles. Functional analyses and thoughts records are for example, used. The intervention 
focuses on the present and not on processing memories. The intervention is made for primary 
care and school health. A psychotherapist/psychologist or social worker will lead the training. 
 
Theory behind the studies 
Compassion focused therapy is a components-based approach that integrates evolutionary 
theory, neurobiology, attachment theory, affect theory, family theory, cognitive behavioral 
principles, and humanistic theory (Gilbert, 2014). 
The originality of the project 
Even though CFT has shown good results for adults, there are only a few small CFT studies 
on adolescents. None of them provide internet-delivered therapy. Our short internet-delivered 
group intervention for youths will be unique and could possibly be a good preventive and 
healing intervention for schools. Primary care and school health care need more efficient 
methods for both preventing and treating distress, anxiety, and depression. 
Many barriers limit treatment uptake, such as limited number of trained therapists, costs, 
compliance issues such as time off work, and transportation, associated with the need to attend 
weekly appointments (Simon et al., 2021). Delivering CFT in groups on the internet may be an 
effective and acceptable alternative to therapist-delivered treatment in primary care and at 
school health care. especially for rural areas.  

 
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Internet delivered such as telehealth, minimize barriers in access to care and address health-
care disparities. Furthermore, internet delivered therapy allows for culturally and linguistically 
competent providers to offer mental health services to adolescents who might not have access 
to such clinicians in their communities. Nevertheless, several challenges have been identified 
in the literature including technological issues (e.g., poor internet connection), privacy and 
confidentiality (e.g. finding a quiet and private location), and safety concerns (Simon et al., 
2021; Stewart et al., 2017). More and better studies with more modern technology are needed 
to develop this further. 
A quality assurance data plan has been written. The investigators will collect quantitative data 
through RED Cap, which is a web survey recommended by Umeå University (Umeå 
University, 2022a). Data from RED Cap is saved at Umeå University. Only anonymous data 
with code will be saved at RED Cap.  
Multifactor authentication is required for logging in to “protective documents” at Umeå 
University, and also for RED Cap, Outlook, TEAMS and other O365 system. The 
investigators are storing sensitive data on Umeå University system for that: protective 
documents (Umeå University, 2022b).  
The investigators are following Swedish archive laws and are using a Umeå University 
system for that (Umeå University & Clinical Science, 2022). 
The investigators will do data checks to compare raw data over time if data quality is 
sustained. Check sum will be used for this. 
A data dictionary that contains detailed descriptions of each variable used by the registry, 
including the source of the variable, and coding information if used and normal ranges if 
relevant, will be performed. 
Standard Operating Procedures have been written to address registry operations and analysis 
activities, such as patient recruitment, data collection, data management, data analysis, 
reporting for adverse events, and change management. 
 
 
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Yourself: A Mixed Methods Pilot Study of a Mindful Self-Compassion Program for 
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0476-6  
Dennhag, I. (2021). Att lära om Self-compassion [eng. To learn about Self-compassion]. Clinical 
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Gilbert, P. (2007). Psychotherapy and counselling for depression (3rd ed.). SAGE.  
Gilbert, P. (2014). The origins and nature of compassion focused therapy. British Journal of 
Clinical Psychology, 53(1), 6-41. https://doi.org/10.1111/bjc.12043  
Jazaieri, H. (2018). Compassionate education from preschool to graduate school: Bringing a 
culture of compassion into the classroom. Journal of Research in Innovative Teaching & 
Learning, 11(1), 22-66. https://doi.org/10.1108/JRIT-08-2017-0017  

 
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Kirby, J. N., Tellegen, C. L., & Steindl, S. R. (2017). A Meta-Analysis of Compassion-Based 
Interventions: Current State of Knowledge and Future Directions. Behavior Therapy, 
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och-digitala-tjanster/samla-in-data/datainsamling-forskning/ 
Umeå University. (2022b). Storing of files with high level of security (In Swedish: Lagra filer med 
högt skyddsvärde i Skyddade dokument). Retrieved 2022-06-20 from 
https://www.aurora.umu.se/stod-och-service/it-och-digitala-tjanster/dokument-
fillagring/skyddade-dokument/ 
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