Mental DisordersNCT01476371
Study of Mindfulness-based Group Treatment in Patients With Depression and Anxiety
A study testing Mindfulness-based group treatment in people with Mental Disorders, run by Lund University.
Trial summary
The purpose of this study is to determine the effectiveness, with respect to symptoms and systemic inflammatory level, of mindfulness-based group treatment compared with normal treatment in patients diagnosed with minor to moderate mental disorders. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Mindfulness-based group treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Apr 2014
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mental disorders: Mild depressive episode (ICD-10 code F32.0)
- Moderate depressive episode (F32.1)
- Depressive episode, unspecified (F32.9)
- Recurrent depressive disorder, current episode mild (F33.0)
- Recurrent depressive disorder, current episode moderate (F33.1)
- Panic disorder (F41.0)
Show all 18Show fewer
- Generalized Anxiety Disorder (F41.1)
- Mixed Anxiety and Depression Adjustment (F41.2)
- Other mixed anxiety disorders (F41.3)
- Other specified anxiety disorders (F41.8)
- Anxiety disorders unspecified (F41.9)
- Adjustment Disorder (F43.2)
- Other reactions to severe stress (F43.8)
- Reaction to severe stress, unspecified (F43.9)
- Age: 20-64 years
- Ability to speak Swedish
- Daily access to the Internet
- Score of ≥10 points on the PHQ-9 OR ≥7 points on the HAD scale OR between 13 and 34 points on the MADRS-S (mild to moderate depression)
Who cannot join
- Serious depression/anxiety that needs psychiatric care
- Personality disorders
- Suicide risk (score of >4 on item 9 of the MADRS-S)
- Ongoing treatment at a psychiatric clinic at the time of recruitment
- Ongoing psychotherapy (e.g., CBT) at the time of recruitment
- Current alcohol, prescription medicine or narcotic abuse
About this study
Official title: Mindfulness-based Group Treatment of Patients With Depression and Anxiety: Effects on Symptoms and Inflammatory Markers in a Randomized Controlled Multicenter Study in Primary Care
The purpose of this study is to determine the effectiveness, with respect to symptoms and systemic inflammatory level, of mindfulness-based group treatment compared with normal treatment in patients diagnosed with minor to moderate mental disorders. The hypothesis is that mindfulness group-treatment 1) will be at least as effective as normal treatment in reducing psychiatric symptoms; 2) will increase quality of life compared with normal treatment; 3) will be costeffective compared with normal treatment; and 4) will reduce inflammation-related markers. The study will be conducted at primary care centers in Skåne, Sweden. We will assess the effect of mindfulness-based group treatment on psychiatric symptoms, quality of life, and health (as rated by the patients themselves) as well as inflammatory markers.
Read the detailed description
Modern cognitive behavioral therapy (CBT) has since the 1990s involved mindfulness, a meditation-based technique that teaches patients to manage their thoughts and feelings. A problem with individual-based psychotherapies is that they are costly, and therapists educated in mindfulness are scarce. Here, we are seeking basis for healthcare providers in primary care to recommend group-based mindfulness training to patients with minor to moderate mental disorders.
Aims of the study:
The primary aim of this study is to assess the effectiveness of mindfulness-based group treatment of patients with minor to moderate mental disorders in primary care through comparison with patients who receive treatment as usual (controls). The cost-effectiveness of mindfulness-based group treatment as an alternative to individual CBT will also be studied. In addition, since increased systemic inflammation has been linked to mental disorders, the effects of the intervention on systemic inflammation-as measured by serum levels of well-established inflammatory and inflammation-related markers (proteins, miRNAs, SNPs, telomere length)-will also be evaluated. Finally, we intend to analyze gene-environment interactions to see if we can find characteristics in the neighbourhood environment that may predict the development of mental disorders in genetically susceptible individuals.
Parameters evaluated in the study:
Parameters assessed at baseline, before the intervention starts: Blood sampling (level of inflammation and inflammation-related markers); Daily functioning (the Global Assessment of Functioning (GAF) scale); Quality of life (the EQ-5D instrument); Symptom Checklist (SCL-90) instrument; self-rated health (a Swedish Survey of Living Conditions (ULF) question with 5 alternative answers); and mindfulness ability (the Mindfulness Attention Awareness Scale (MAAS)). Post-intervention: Blood sampling, Level of depression (as assessed using the Montgomery-Asberg Depression Rating Scale (MADRS-S); the Patient Health Questionnaire (PHQ-9); Anxiety level and stress reactions (the Hospital Anxiety and Depression (HAD) scale); as well as the above described GAF, EQ-5D, SCL-90, ULF and MAAS. Follow-up: the patients will be assessed by the PHQ-9, HAD, MADRS-S, EQ-5D, GAF, SCL-90, ULF and MAAS questionnaires 6, 12 and 24 months after the end of intervention. As a co-variate to the above described parameters, we will analyze Geographic Information System (GIS)-coordinates for neighbourhood social and physical characteristics.
Study design:
Patients seeking treatment for minor to moderate mental disorders at one of 17 primary care centers in Skåne County, Sweden, and satisfying the inclusion criteria listed below, will be invited to enroll in the study. A total of 30 health care providers (1-2 per primary care center) will be trained as mindfulness instructors. The recruited patients (estimated total 300) will be randomly assigned to one of two groups: the first will receive mindfulness-based group treatment and the second treatment as usual. Patients in both groups will be invited for an initial consultation, during which they will be asked to provide blood samples for analysis of inflammation-related markers, and to complete the questionnaires listed above. Details of the medications the patients are currently taking will be recorded. These consultations will take place before the intervention begins.
The intervention will consist of 8-weeks of mindfulness-based group treatment (one 2-hour session per week; 10 patients per group). Each group session will be led by two mindfulness instructors, who will lead the patients through the Here \& Now mindfulness program. Between sessions, patients will perform additional mindfulness practice at home via the Internet. A mindfulness instructor will complete a case report form (CRF) for each patient. This CRF will include records of attendance at the group sessions and details of any medications taken (patients in both the control and intervention groups will be prescribed drugs for their mental disorders as their GPs deem appropriate). The patients will themselves keep a record of the mindfulness practice they perform at home.
Patients in the control group will receive treatment as usual, which may consist of CBT, counseling, or other forms of therapy that are provided in primary care. Full details of the treatment each patient in the control group receives will be recorded in the CRF.
Follow-up will be performed 1 week after the end of the intervention in the intervention group, and after 8 weeks of treatment as usual in the control group. All patients will be asked to fill in the questionnaires listed above and to provide blood samples for analysis of inflammation-related marker levels. Patients will be asked to complete further questionnaires at 6, 12, and 24 months after completion of the intervention.
- Conditions
- Mental Disorders
- Being tested
- Mindfulness-based group treatment
- Keywords
- Group treatment, Mindfulness, Minor mental disorders, Inflammation
- Medical subject headings
- Mental Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based group treatmentBehavioural
Also called Mindfulness
An 8-week course of mindfulness-based group treatment (one 2-hour session per week; 10 patients per group). Each group session will be led by two mindfulness instructors, who will lead the patients through the Here \& Now mindfulness program. Between sessions, patients will perform additional mindfulness practice at home via the Internet.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based group treatment | Experimental | 8 group mindfulness sessions (1 per week), complemented by home mindfulness exercises Receives: Behavioral: Mindfulness-based group treatment |
| Treatment as usual | No intervention | Treatment as usual (including individual CBT and medication) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms
MADRS-S total score after treatment
Measured: Week 8
Secondary outcomes (4)
Depression symptoms
PHQ-9 score after treatment and after 6, 12, and 24 months after completion of treatment
Measured: 1 week after treatment, and 6, 12, and 24 months after completion of the treatment
Anxiety and depression symptoms
HAD score after treatment and after 6, 12, and 24 months
Measured: 1 week after treatment and 6, 12, and 24 months after completion of the treatment
Self-rated health
SCL-90 score after treatment and 6, 12, and 24 months after treatment
Measured: 8 weeks, 6, 12 and 25 months
Systemic inflammation
Serum levels of the following inflammatory factors will be measured by enzyme-linked immunosorbent assay (ELISA): epidermal growth factors, adiponectin, high-sensitivity C-reactive protein (hs-CRP), interferon (IFN)-γ, interleukin (IL)-1β, IL-6, IL-10 and tumor necrosis factor (TNF)-α. Serum levels of microRNA and telomere length will be measured by RT-PCR.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Sundquist, Lund University
- Investigators
- Jan Sundquist, M.D., Ph.D., Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476371
- Sponsor's protocol ID
- CPF-0001
- Status last verified
- Mar 2025
- First submitted
- 11 Nov 2011
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Saha S, Jarl J, Gerdtham UG, Sundquist K, Sundquist J. Economic evaluation of mindfulness group therapy for patients with depression, anxiety, stress and adjustment disorders compared with treatment as usual. Br J Psychiatry. 2020 Apr;216(4):197-203. doi: 10.1192/bjp.2018.247.
PubMed 30468136Sundquist J, Palmer K, Memon AA, Wang X, Johansson LM, Sundquist K. Long-term improvements after mindfulness-based group therapy of depression, anxiety and stress and adjustment disorders: A randomized controlled trial. Early Interv Psychiatry. 2019 Aug;13(4):943-952. doi: 10.1111/eip.12715. Epub 2018 Jul 3.
PubMed 29968371Wang X, Sundquist K, Hedelius A, Palmer K, Memon AA, Sundquist J. Leukocyte telomere length and depression, anxiety and stress and adjustment disorders in primary health care patients. BMC Psychiatry. 2017 Apr 24;17(1):148. doi: 10.1186/s12888-017-1308-0.
PubMed 28438147Sundquist J, Palmer K, Johansson LM, Sundquist K. The effect of mindfulness group therapy on a broad range of psychiatric symptoms: A randomised controlled trial in primary health care. Eur Psychiatry. 2017 Jun;43:19-27. doi: 10.1016/j.eurpsy.2017.01.328. Epub 2017 Feb 8.
PubMed 28365464Sundquist J, Lilja A, Palmer K, Memon AA, Wang X, Johansson LM, Sundquist K. Mindfulness group therapy in primary care patients with depression, anxiety and stress and adjustment disorders: randomised controlled trial. Br J Psychiatry. 2015 Feb;206(2):128-35. doi: 10.1192/bjp.bp.114.150243. Epub 2014 Nov 27.
PubMed 25431430
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Group Treatment of Patients With Depression and Anxiety: Effects on Symptoms and Inflammatory Markers in a Randomized Controlled Multicenter Study in Primary Care
- ClinicalTrials.gov ID
- NCT01476371
- Acronym / sponsor ID
- CPF-0001
- Conditions
- Mental Disorders
- Keywords
- Group treatment, Mindfulness, Minor mental disorders, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Nov 2011 (estimated)
- 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.
The purpose of this study is to determine the effectiveness, with respect to symptoms and systemic inflammatory level, of mindfulness-based group treatment compared with normal treatment in patients diagnosed with minor to moderate mental disorders. The hypothesis is that mindfulness group-treatment 1) will be at least as effective as normal treatment in reducing psychiatric symptoms; 2) will increase quality of life compared with normal treatment; 3) will be costeffective compared with normal treatment; and 4) will reduce inflammation-related markers. The study will be conducted at primary care centers in Skåne, Sweden. We will assess the effect of mindfulness-based group treatment on psychiatric symptoms, quality of life, and health (as rated by the patients themselves) as well as inflammatory markers.
Detailed description
Modern cognitive behavioral therapy (CBT) has since the 1990s involved mindfulness, a meditation-based technique that teaches patients to manage their thoughts and feelings. A problem with individual-based psychotherapies is that they are costly, and therapists educated in mindfulness are scarce. Here, we are seeking basis for healthcare providers in primary care to recommend group-based mindfulness training to patients with minor to moderate mental disorders.
Aims of the study:
The primary aim of this study is to assess the effectiveness of mindfulness-based group treatment of patients with minor to moderate mental disorders in primary care through comparison with patients who receive treatment as usual (controls). The cost-effectiveness of mindfulness-based group treatment as an alternative to individual CBT will also be studied. In addition, since increased systemic inflammation has been linked to mental disorders, the effects of the intervention on systemic inflammation-as measured by serum levels of well-established inflammatory and inflammation-related markers (proteins, miRNAs, SNPs, telomere length)-will also be evaluated. Finally, we intend to analyze gene-environment interactions to see if we can find characteristics in the neighbourhood environment that may predict the development of mental disorders in genetically susceptible individuals.
Parameters evaluated in the study:
Parameters assessed at baseline, before the intervention starts: Blood sampling (level of inflammation and inflammation-related markers); Daily functioning (the Global Assessment of Functioning (GAF) scale); Quality of life (the EQ-5D instrument); Symptom Checklist (SCL-90) instrument; self-rated health (a Swedish Survey of Living Conditions (ULF) question with 5 alternative answers); and mindfulness ability (the Mindfulness Attention Awareness Scale (MAAS)). Post-intervention: Blood sampling, Level of depression (as assessed using the Montgomery-Asberg Depression Rating Scale (MADRS-S); the Patient Health Questionnaire (PHQ-9); Anxiety level and stress reactions (the Hospital Anxiety and Depression (HAD) scale); as well as the above described GAF, EQ-5D, SCL-90, ULF and MAAS. Follow-up: the patients will be assessed by the PHQ-9, HAD, MADRS-S, EQ-5D, GAF, SCL-90, ULF and MAAS questionnaires 6, 12 and 24 months after the end of intervention. As a co-variate to the above described parameters, we will analyze Geographic Information System (GIS)-coordinates for neighbourhood social and physical characteristics.
Study design:
Patients seeking treatment for minor to moderate mental disorders at one of 17 primary care centers in Skåne County, Sweden, and satisfying the inclusion criteria listed below, will be invited to enroll in the study. A total of 30 health care providers (1-2 per primary care center) will be trained as mindfulness instructors. The recruited patients (estimated total 300) will be randomly assigned to one of two groups: the first will receive mindfulness-based group treatment and the second treatment as usual. Patients in both groups will be invited for an initial consultation, during which they will be asked to provide blood samples for analysis of inflammation-related markers, and to complete the questionnaires listed above. Details of the medications the patients are currently taking will be recorded. These consultations will take place before the intervention begins.
The intervention will consist of 8-weeks of mindfulness-based group treatment (one 2-hour session per week; 10 patients per group). Each group session will be led by two mindfulness instructors, who will lead the patients through the Here \& Now mindfulness program. Between sessions, patients will perform additional mindfulness practice at home via the Internet. A mindfulness instructor will complete a case report form (CRF) for each patient. This CRF will include records of attendance at the group sessions and details of any medications taken (patients in both the control and intervention groups will be prescribed drugs for their mental disorders as their GPs deem appropriate). The patients will themselves keep a record of the mindfulness practice they perform at home.
Patients in the control group will receive treatment as usual, which may consist of CBT, counseling, or other forms of therapy that are provided in primary care. Full details of the treatment each patient in the control group receives will be recorded in the CRF.
Follow-up will be performed 1 week after the end of the intervention in the intervention group, and after 8 weeks of treatment as usual in the control group. All patients will be asked to fill in the questionnaires listed above and to provide blood samples for analysis of inflammation-related marker levels. Patients will be asked to complete further questionnaires at 6, 12, and 24 months after completion of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based group treatment | Experimental | Behavioral: Mindfulness-based group treatment8 group mindfulness sessions (1 per week), complemented by home mindfulness exercises |
| Treatment as usual | No intervention | –Treatment as usual (including individual CBT and medication) |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Mental disorders: Mild depressive episode (ICD-10 code F32.0)
- Moderate depressive episode (F32.1)
- Depressive episode, unspecified (F32.9)
- Recurrent depressive disorder, current episode mild (F33.0)
- Recurrent depressive disorder, current episode moderate (F33.1)
Key exclusion criteria (6 listed)
- Serious depression/anxiety that needs psychiatric care
- Personality disorders
- Suicide risk (score of >4 on item 9 of the MADRS-S)
- Ongoing treatment at a psychiatric clinic at the time of recruitment
- Ongoing psychotherapy (e.g., CBT) at the time of recruitment
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 |
|---|---|---|
| Mindfulness-based group treatmentAlso: MindfulnessAn 8-week course of mindfulness-based group treatment (one 2-hour session per week; 10 patients per group). Each group session will be led by two mindfulness instructors, who will lead the patients through the Here \& Now mindfulness program. Between sessions, patients will perform additional mindfulness practice at home via the Internet. | Behavioural | Mindfulness-based group treatment |
Primary outcome
Depression symptoms
Time frame: Week 8
MADRS-S total score after treatment
4 secondary outcomes
Depression symptoms
Time frame: 1 week after treatment, and 6, 12, and 24 months after completion of the treatment
Anxiety and depression symptoms
Time frame: 1 week after treatment and 6, 12, and 24 months after completion of the treatment
Self-rated health
Time frame: 8 weeks, 6, 12 and 25 months
Systemic inflammation
Time frame: 8 weeks
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 7 Mar 2025.
- Derived from this study: PubMed 30468136Saha S, Jarl J, Gerdtham UG, Sundquist K, Sundquist J. Economic evaluation of mindfulness group therapy for patients with depression, anxiety, stress and adjustment disorders compared with treatment as usual. Br J Psychiatry. 2020 Apr;216(4):197-203. doi: 10.1192/bjp.2018.247.
- Derived from this study: PubMed 29968371Sundquist J, Palmer K, Memon AA, Wang X, Johansson LM, Sundquist K. Long-term improvements after mindfulness-based group therapy of depression, anxiety and stress and adjustment disorders: A randomized controlled trial. Early Interv Psychiatry. 2019 Aug;13(4):943-952. doi: 10.1111/eip.12715. Epub 2018 Jul 3.
- Derived from this study: PubMed 28438147Wang X, Sundquist K, Hedelius A, Palmer K, Memon AA, Sundquist J. Leukocyte telomere length and depression, anxiety and stress and adjustment disorders in primary health care patients. BMC Psychiatry. 2017 Apr 24;17(1):148. doi: 10.1186/s12888-017-1308-0.
- Derived from this study: PubMed 28365464Sundquist J, Palmer K, Johansson LM, Sundquist K. The effect of mindfulness group therapy on a broad range of psychiatric symptoms: A randomised controlled trial in primary health care. Eur Psychiatry. 2017 Jun;43:19-27. doi: 10.1016/j.eurpsy.2017.01.328. Epub 2017 Feb 8.
- Derived from this study: PubMed 25431430Sundquist J, Lilja A, Palmer K, Memon AA, Wang X, Johansson LM, Sundquist K. Mindfulness group therapy in primary care patients with depression, anxiety and stress and adjustment disorders: randomised controlled trial. Br J Psychiatry. 2015 Feb;206(2):128-35. doi: 10.1192/bjp.bp.114.150243. Epub 2014 Nov 27.
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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.
Jan Sundquist, M.D., Ph.D. principal investigator
Lund University
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based group treatment in people with Mental Disorders, run by Lund University.
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 18 inclusion and 6 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 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Depression symptoms (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01476371, which also lists 5 linked publications.
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 7 Mar 2025.