An interventional study of Mindfulness-based group treatment in Mental Disorders, sponsored by Lund University. Completed. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by Lund University · Not applicable, Interventional, and Treatment
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.
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.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's enrollment of 215 is above the median of 94 across 1,574 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Lund University is the lead sponsor of 230 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
8 group mindfulness sessions (1 per week), complemented by home mindfulness exercises
Behavioral: Mindfulness-based group treatment
Treatment as usual (including individual CBT and medication)
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.
Also known as: Mindfulness
Depression symptoms
MADRS-S total score after treatment
Time frame: Week 8
Depression symptoms
PHQ-9 score after treatment and after 6, 12, and 24 months after completion of treatment
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 8 weeks
No study locations are listed for this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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