NCT05448014

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 we 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. We 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 40 adolescents. The effect, feasibility, and acceptability of the therapist-led online CFT in groups will be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
12 months until next milestone

Results Posted

Study results publicly available

May 30, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

June 20, 2022

Results QC Date

April 7, 2025

Last Update Submit

May 12, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Perceived Stress Scale

    The 10-item Perceived Stress Scale (PSS-10) measures perceived stress related to unpredictability, uncontrollability, and overload in daily life. Each item is rated on a 5-point scale from 0 (never) to 4 (very often), yielding a total score ranging from 0 to 40. Higher scores indicate higher levels of perceived stress. In this study, the total score was used for analysis.

    8 weeks

  • The Subscale Anxiety in Trauma Symptom Checklist for Children

    The Trauma Symptom Checklist for Children (TSCC), Anxiety Subscale, measures trauma-related anxiety symptoms in children and adolescents. The subscale includes 9 items rated on a 4-point scale from 0 (never) to 3 (almost all the time). Total scores range from 0 to 27, with higher scores indicating more severe anxiety symptoms.

    8- weeks

  • The Subscale Depression in Trauma Symptom Checklist for Children

    The Trauma Symptom Checklist for Children (TSCC), Depression Subscale, measures trauma-related depressive symptoms in children and adolescents. The subscale includes 9 items rated on a 4-point scale from 0 (never) to 3 (almost all the time). Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.

    8 weeks

Study Arms (2)

CFT group intervention

EXPERIMENTAL

Compassion Focused Therapy in Group on the internet

Behavioral: Compassion focused group therapy online

Control group

NO INTERVENTION

Waiting list

Interventions

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.

CFT group intervention

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • Bipolar Disorder
  • Autism
  • Anorexia Nervosa
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inga Dennhag

Umeå, 91136, Sweden

Location

Related Publications (17)

  • 1. WHO (2019). Spotlight on adolescent health and well-being: Findings from the 2017/2018 health behaviour in school-aged children (HBSC) survey in Europe and Canada. In J. Inchley (Ed.), (Vol. 2).

    BACKGROUND
  • 2. World Health Organization (2017). Depression and other common mental disorders: Global health estimates. http://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf;jsessionid=5C6C365CE6CA46022D8AE57751200AE9?sequence=1.

    BACKGROUND
  • 3. 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, doi:10.1108/JRIT-08-2017-0017.

    BACKGROUND
  • Gilbert P. The origins and nature of compassion focused therapy. Br J Clin Psychol. 2014 Mar;53(1):6-41. doi: 10.1111/bjc.12043.

    PMID: 24588760BACKGROUND
  • 5. Gilbert, P. (2007). Psychotherapy and counselling for depression (3rd ed.). Los Angeles: SAGE.

    BACKGROUND
  • Zeller M, Yuval K, Nitzan-Assayag Y, Bernstein A. Self-compassion in recovery following potentially traumatic stress: longitudinal study of at-risk youth. J Abnorm Child Psychol. 2015 May;43(4):645-53. doi: 10.1007/s10802-014-9937-y.

    PMID: 25234347BACKGROUND
  • Kirby JN, Tellegen CL, Steindl SR. A Meta-Analysis of Compassion-Based Interventions: Current State of Knowledge and Future Directions. Behav Ther. 2017 Nov;48(6):778-792. doi: 10.1016/j.beth.2017.06.003. Epub 2017 Jun 21.

    PMID: 29029675BACKGROUND
  • Bluth K, Gaylord SA, Campo RA, Mullarkey MC, Hobbs L. Making Friends With Yourself: A Mixed Methods Pilot Study of a Mindful Self-Compassion Program for Adolescents. Mindfulness (N Y). 2016 Mar 1;7(2):479-492. doi: 10.1007/s12671-015-0476-6. Epub 2015 Dec 19.

    PMID: 27110301BACKGROUND
  • 9. Dennhag, I. (2021). Att lära om Self-compassion [eng. To learn about Self-compassion]. (pp. 66). Umeå Universitet, Sweden: Clinical Science.

    BACKGROUND
  • 10. Welford, M., & Beaumont, E. (2020). The kindness workbook: Creative and compassionate ways to boost your wellbeing. London: Robinson Publishing.

    BACKGROUND
  • Simon N, Robertson L, Lewis C, Roberts NP, Bethell A, Dawson S, Bisson JI. Internet-based cognitive and behavioural therapies for post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2021 May 20;5(5):CD011710. doi: 10.1002/14651858.CD011710.pub3.

    PMID: 34015141BACKGROUND
  • Stewart RW, Orengo-Aguayo RE, Cohen JA, Mannarino AP, de Arellano MA. A Pilot Study of Trauma-Focused Cognitive-Behavioral Therapy Delivered via Telehealth Technology. Child Maltreat. 2017 Nov;22(4):324-333. doi: 10.1177/1077559517725403. Epub 2017 Sep 4.

    PMID: 28868894BACKGROUND
  • 13. Umeå University (2022). REDCap - data collection in research studies (In Swedish: REDCap - Datainsamling vid forskningsstudier). https://www.aurora.umu.se/stod-och-service/it-och-digitala-tjanster/samla-in-data/datainsamling-forskning/.

    BACKGROUND
  • 14. Umeå University (2022). Storing of files with high level of security (In Swedish: Lagra filer med högt skyddsvärde i Skyddade dokument). https://www.aurora.umu.se/stod-och-service/it-och-digitala-tjanster/dokument-fillagring/skyddade-dokument/. Accessed 2022-06-20.

    BACKGROUND
  • 15. Umeå University, & Clinical Science (2022). Research Archive Clinical Science (In Swedish Forskningsarkivet Klinisk Vetenskap). http://foark.klinvet.umu.se:5000/#/signin.

    BACKGROUND
  • 16. Blampied, N. M., Conference, N., & Wellington (2016). Reliable change & the reliable change index in the context of evidence-based practice: A tutorial review. https://ir.canterbury.ac.nz/handle/10092/13399

    BACKGROUND
  • Vestin M, Wallin L, Naesstrom M, Blomqvist I, Svedin CG, Beaumont E, Jokinen J, Dennhag I. Internet-based group compassion-focused therapy for Swedish young people with stress, anxiety and depression: a pilot waitlist randomized controlled trial. Front Psychol. 2025 Apr 1;16:1547046. doi: 10.3389/fpsyg.2025.1547046. eCollection 2025.

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Limitations and Caveats

This study has several limitations. It was a pilot RCT feasibility study with a small sample size and preliminary efficacy results.

Results Point of Contact

Title
Inga Dennhag, Associate Professor
Organization
Umeå University

Study Officials

  • Inga Dennhag, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study design: A two-arm (treatment group vs. control group) pilot randomized controlled trial will be carried out with 40 adolescents.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, lecturer

Study Record Dates

First Submitted

June 20, 2022

First Posted

July 7, 2022

Study Start

June 1, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

May 30, 2025

Results First Posted

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations