ClinicalTrials.gg
CompletedNCT07876453Updated Oct 21, 2026

Feasibility and Preliminary Outcomes of Compassion-Focused Group Therapy for Depression and Anxiety

An interventional study of Compassion-Focused Group Therapy (CFT) in Depression / Major Depressive Disorder and Anxiety Disorder (Panic Disorder or GAD), sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Jul 2023, registered Oct 2026).
Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This pilot study evaluated the feasibility and preliminary outcomes of compassion-focused group therapy (CFT) for adults with depression and/or anxiety who continued to experience symptoms despite previous treatment.

CFT aims to help individuals develop a more compassionate attitude toward themselves and reduce self-criticism and shame, which may contribute to psychological distress.

The study was conducted at a specialized psychiatric outpatient clinic in Stockholm, Sweden, during 2023-2024. A total of 21 participants received an 11-week group treatment consisting of weekly group sessions and brief individual telephone consultations.

The study examined whether participants were willing and able to complete the treatment and whether the treatment was acceptable and feasible in routine psychiatric care. Changes in self-compassion, depressive symptoms, difficulties in emotion regulation, social safeness, everyday functioning, and quality of life were assessed before treatment, immediately after treatment, and three months later.

The findings were intended to inform the further development and evaluation of compassion-focused group therapy for patients with persistent depression and anxiety symptoms.

Read the detailed description

Depression and anxiety disorders are common psychiatric conditions, and some patients continue to experience significant symptoms despite receiving recommended psychological or pharmacological treatments. Compassion-focused therapy (CFT) is a psychological treatment approach developed to address self-criticism, shame, and difficulties in developing self-compassion. CFT may be particularly relevant for patients with persistent symptoms and pronounced self-critical thinking.

This study was an open-label, single-arm pilot study conducted in a specialized psychiatric outpatient setting in Stockholm, Sweden, during 2023-2024. Its primary aim was to evaluate the feasibility and acceptability of an 11-week manualized compassion-focused group intervention and to explore preliminary clinical outcomes.

Participants were adults with moderate to severe symptoms of depression and/or anxiety who had previously received at least one treatment consistent with Swedish national treatment guidelines and reported difficulties related to self-criticism or shame. Patients requiring immediate inpatient or emergency care, or unable to independently complete study questionnaires, were not eligible.

The intervention consisted of 11 weekly group sessions lasting approximately 2 hours and 15 minutes each, supplemented by weekly individual telephone consultations of approximately 15 minutes. The treatment included psychoeducation, experiential exercises, compassion-focused practices, meditation, and individual case conceptualization. Additional individual appointments were offered before treatment, midway through treatment, and at the three-month follow-up.

Feasibility was evaluated through recruitment and treatment initiation, treatment retention, attendance at group sessions, and participation in scheduled telephone consultations. The primary clinical outcome was self-compassion, assessed using the Self-Compassion Scale-Short Form (SCS-SF).

Secondary clinical outcomes included depressive symptoms (Patient Health Questionnaire-9, PHQ-9), difficulties in emotion regulation (Difficulties in Emotion Regulation Scale-16, DERS-16), social safeness (Social Safeness and Pleasure Scale, SSPS), functional impairment (World Health Organization Disability Assessment Schedule 2.0, WHODAS-12), and quality of life (Brunnsviken Brief Quality of Life Scale, BBQ).

Clinical outcomes were assessed at baseline, immediately after treatment, and at a three-month follow-up. The study included 21 participants allocated to three treatment groups. As a single-arm pilot study without a control group, it was designed to assess feasibility and explore preliminary changes rather than establish treatment efficacy.

The findings were intended to guide future research and the potential implementation of compassion-focused group therapy within specialized psychiatric outpatient care.

02

Conditions studied

  • Depression / Major Depressive Disorder
  • Anxiety Disorder (Panic Disorder or GAD)

Keywords

  • Group psychotherapy
  • Self-compassion
  • Self-Criticism
  • Compassion Focused Therapy
  • Feasibility study
03

In context

Depression

8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 21 is below the median of 84 across 6,869 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,145 studies on the registry; 274 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older.
  • Previously completed at least one pharmacological or psychological treatment consistent with Swedish national treatment guidelines for depression and/or anxiety disorders.
  • Moderate to severe symptoms of depression and/or anxiety.
  • Self-reported difficulties related to self-criticism or shame during the initial assessment.

Exclusion criteria

Exclusion Criteria:

  • Inability to independently complete self-report questionnaires due to cognitive difficulties and/or insufficient Swedish language proficiency.
  • Practical or scheduling difficulties preventing participation in group treatment.
  • Acute physical or psychiatric conditions requiring immediate hospital care, such as severe underweight or an acute suicidal crisis.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Compassion-Focused Group Therapy (CFT)

    Participants received an 11-week manualized compassion-focused group therapy intervention consisting of weekly group sessions and brief individual telephone consultations. The intervention aimed to increase self-compassion and address self-criticism and shame in adults with persistent symptoms of depression and/or anxiety.

    Behavioral: Compassion-Focused Group Therapy (CFT)

Interventions

  • BehavioralCompassion-Focused Group Therapy (CFT)

    An 11-week manualized compassion-focused group therapy intervention. Participants attended weekly group sessions lasting approximately 2 hours and 15 minutes, supplemented by weekly individual telephone consultations of approximately 15 minutes. The treatment included psychoeducation, experiential exercises, meditation, compassion-focused practices, and individual case conceptualization. Individual appointments were also offered before treatment, midway through treatment, and at the three-month follow-up.

06

What researchers measure

Primary outcomes

  1. Treatment Completion Rate

    The proportion of enrolled participants who completed the 11-week compassion-focused group therapy intervention. Treatment completion was assessed as an indicator of treatment feasibility

    Time frame: From treatment initiation to treatment completion (11 weeks).

Secondary outcomes

  1. Change in Self-Compassion (SCS-SF)

    Self-compassion was assessed using the 12-item Self-Compassion Scale-Short Form (SCS-SF). Higher scores indicate greater self-compassion. The minimum possible score is 12, and the maximum possible score is 60.

    Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.

  2. Change in Depressive Symptoms (PHQ-9)

    Depressive symptoms were assessed using the 9-item Patient Health Questionnaire (PHQ-9), including 9 items, with higher scores indicating more severe depressive symptoms. The minimum possible score is 0, and the maximum possible score is 27.

    Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.

  3. Change in Difficulties in Emotion Regulation (DERS-16)

    Difficulties in emotion regulation were assessed using the 16-item Difficulties in Emotion Regulation Scale (DERS-16), including 16 items. Higher scores indicate greater difficulties in emotion regulation. The minimum possible score is 16, and the maximum possible score is 80.

    Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.

  4. Change in Social Safeness (SSPS)

    Social safeness was assessed using the Social Safeness and Pleasure Scale (SSPS), including 11 items. Higher scores indicate greater perceived social safeness. The minimum possible score is 11, and the maximum possible score is 55.

    Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.

  5. Change in Functional Impairment (WHODAS-12)

    Functional impairment was assessed using the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS-12). Higher scores indicate greater functional impairment. The minimum possible score is 0, and the maximum possible score is 48.

    Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.

  6. Change in Quality of Life (BBQ)

    Quality of life was assessed using the Brunnsviken Brief Quality of Life Scale (BBQ), covering six life domains. For each domain, respondents rate both their satisfaction and the importance of that domain on a scale from 0 to 4. The two ratings are multiplied, and the resulting scores are summed across the six domains. Higher scores indicate better perceived quality of life. The minimum possible score is 0, and the maximum possible score is 96.

    Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.

Other outcomes

  1. Group Session Attendance Rate

    Group Session Attendance Rate during the treatment phase

    Time frame: during 11-weeks treatment

  2. Telephone Consultation Completion Rate

    Completion of weekly phone consultations (15 minutes) during treatment

    Time frame: during 11-weeks treatment

  3. Treatment Initiation Rate

    The proportion of eligible patients who agreed to initiate compassion-focused group therapy, calculated as the number of patients who agreed to participate divided by the total number of eligible patients offered treatment, expressed as a percentage.

    Time frame: During recruitment, prior to treatment initiation.

07

Study locations

1 site
  • Sollentuna Psychiatric Outpatient Clinic, Psychiatry Northwest (Psykiatri Nordväst)
    Stockholm, Sweden
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to the sensitive nature of the mental health information collected and the need to protect participant confidentiality. The study was conducted in a specialized psychiatric setting with a relatively small sample, which may increase the risk of participant identification.

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2023 to primary completion in Apr 2024, 9 months.

Of 3,016 non-industry interventional studies with no phase under Depression, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 9 months is below that.

Counting every sponsor, half of 3,112 studies reached it within 22 months; a quarter within 10 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2026
First posted
Oct 15, 2026
StartActual
Jul 1, 2023
Primary completionActual
Apr 8, 2024
CompletionActual
Apr 8, 2024
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 2 updates
  1. Oct 21, 2026
    Minor edits only
    + 1 other change: secondary outcomes
  2. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07876453
Responsible party
Martina Wolf-Arehult (PhD, Karolinska Institutet) — Principal investigator
First posted
Oct 15, 2026
Start date
Jul 1, 2023
Primary completion
Apr 8, 2024
Completion
Apr 8, 2024
Last update
Oct 21, 2026

Study contacts

Martina Wolf-Arehult, PhD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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