Depression / Major Depressive DisorderNCT07876453
Feasibility and Preliminary Outcomes of Compassion-Focused Group Therapy for Depression and Anxiety
A study testing Compassion-Focused Group Therapy (CFT) in people with Depression / Major Depressive Disorder and Anxiety Disorder (Panic Disorder or GAD), run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression / Major Depressive Disorder, Anxiety Disorder (Panic Disorder or GAD)
- What is being tested?
- Compassion-Focused Group Therapy (CFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jul 2023to 8 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sollentuna Psychiatric Outpatient Clinic, Psychiatry Northwest (Psykiatri Nordväst)
Stockholm
About this study
Official title: Investigation of Loneliness and Its Associations With Emotion Regulation, Lifestyle Habits, Mental Health Problems, and Psychotherapeutic Treatment Outcomes, Substudy 5: Compassion-Focused Therapy (CFT) for Depression and Anxiety Disorders
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.
Read more
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.
- Being tested
- Compassion-Focused Group Therapy (CFT)
- Keywords
- Group psychotherapy, Self-compassion, Self-Criticism, Compassion Focused Therapy, Feasibility study
- Medical subject headings
- Depression, Depressive Disorder, Major, Anxiety Disorders, Panic Disorder, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion-Focused Group Therapy (CFT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Compassion-Focused Group Therapy (CFT) | Experimental | 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. Receives: Behavioral: Compassion-Focused Group Therapy (CFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From treatment initiation to treatment completion (11 weeks).
Secondary outcomes (6)
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.
Measured: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.
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.
Measured: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.
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.
Measured: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.
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.
Measured: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.
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.
Measured: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.
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.
Measured: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Jul 2023
- Primary completion8 Apr 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression / Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This was an open-label, single-arm pilot study evaluating the feasibility and preliminary clinical outcomes of an 11-week compassion-focused group therapy intervention. All participants received the same intervention, delivered in three treatment groups. There was no randomization or control group. Clinical outcomes were assessed at baseline, post-treatment, and three-month follow-up.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Wolf-Arehult, Karolinska Institutet
- Investigators
- Martina Wolf-Arehult, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876453
- Sponsor's protocol ID
- 2021-05392-01
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Loneliness and Its Associations With Emotion Regulation, Lifestyle Habits, Mental Health Problems, and Psychotherapeutic Treatment Outcomes, Substudy 5: Compassion-Focused Therapy (CFT) for Depression and Anxiety Disorders
- ClinicalTrials.gov ID
- NCT07876453
- Acronym / sponsor ID
- 2021-05392-01
- Keywords
- Group psychotherapy, Self-compassion, Self-Criticism, Compassion Focused Therapy, Feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This was an open-label, single-arm pilot study evaluating the feasibility and preliminary clinical outcomes of an 11-week compassion-focused group therapy intervention. All participants received the same intervention, delivered in three treatment groups. There was no randomization or control group. Clinical outcomes were assessed at baseline, post-treatment, and three-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Compassion-Focused Group Therapy (CFT) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compassion-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. | Behavioural | Compassion-Focused Group Therapy (CFT) |
Primary outcome
Treatment Completion Rate
Time frame: From treatment initiation to treatment completion (11 weeks).
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
6 secondary outcomes
Change in Self-Compassion (SCS-SF)
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.
Change in Depressive Symptoms (PHQ-9)
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.
Change in Difficulties in Emotion Regulation (DERS-16)
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.
Change in Social Safeness (SSPS)
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.
Change in Functional Impairment (WHODAS-12)
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.
Change in Quality of Life (BBQ)
Time frame: Baseline, post-treatment (11 weeks), and 3-month follow-up after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: 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.
Related trials for Depression / Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martina Wolf-Arehult, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion-Focused Group Therapy (CFT) in people with Depression / Major Depressive Disorder and Anxiety Disorder (Panic Disorder or GAD), run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Completion Rate (time frame: From treatment initiation to treatment completion (11 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.