An interventional study of Mindfulness based cognitive therapy (MBCT) and Treatment as usual (TAU) in Depression, Anxiety, sponsored by University of Iceland. Completed at 2 sites in Iceland. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2020-11-04.
Sponsored by University of Iceland · Not applicable, Interventional, and Health services research
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This study is done to evaluate the effects of Mindfulness Based Cognitive Therapy (MBCT) for primary care patients that have mild to moderate symptoms of depression and anxiety. Half of the study participants will receive treatment as usual (TAU), and the other half will receive TAU plus MBCT. The investigators will be comparing changes in symptoms of depression and anxiety between the groups, and hypothesize that the TAU plus MBCT group will have significantly lower symptoms of depression and anxiety compared to TAU group post-intervention
Patients that show mild to moderate symptoms of depression and anxiety are common in the primary care setting. These patients are often treated with antidepressant or anxiolytic medication instead of cognitive therapy, which is the first choice of treatment according to clinical guidelines in Iceland. Although these patients are often referred to cognitive therapy, there are long waiting lists for group therapy and personal therapy is expensive. MBCT has been shown to have good effects on people with recurrent depression and on patients suffering from anxiety. Therefore, the investigators main objective is to assess whether MBCT is effective in the primary care setting for patients with mild symptoms of anxiety and depression and compare its effect to TAU.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
This study's enrollment of 120 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Browse Depression studies →University of Iceland is the lead sponsor of 35 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
F00-F09 Organic, including symptomatic, mental disorders F10-F19 Mental and behavioural disorders due to psychoactive substance use F20-F29 Schizophrenia, schizotypal and delusional disorders F70-F79 Mental retardation
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This group receives treatment as usual (TAU) from his/hers physician. This treatment is different for each physician, but mainly consists of cognitive therapy, personal interviews or antidepressants or anxiolytics.
Other: Treatment as usual (TAU)
Mindfulness Based Cognitive Therapy (MBCT). This group receives 8 weeks of MBCT in addition to usual treatment (TAU). The MBCT consists of weekly group sessions of 2,5 hours, where participants receive cognitive therapy as well as mindfulness meditation. This group is also assigned homework, according to the MBCT protocol..
Behavioral: Mindfulness based cognitive therapy (MBCT) · Other: Treatment as usual (TAU)
Mindfulness Based Cognitive Therapy (MBCT). This group receives 8 weeks of MBCT in addition to usual treatment (TAU). The MBCT consists of weekly group sessions of 2,5 hours, where participants receive cognitive therapy as well as mindfulness meditation. This group is also assigned homework, according to the MBCT protocol.
Usual treatment prescribed by each physician, specifically interview therapy, cognitive therapy, antidepressants and/or anxiolytics as well as a mixture of all of the above.
Symptoms of depression measured with the PHQ-9 questionnaire
Comparing scores on the PHQ-9 before and after the intervention as well as, 6 and 18 months after the intervention for both the control group (TAU) and the intervention group (TAU plus MBCT)
Time frame: up to 18 months
Symptoms of anxiety measured with the GAD-7 questionnaire
Comparing scores on the GAD-7 before and after the intervention as well as 6 and 18 months after the intervention for both the control group (TAU) and the intervention group (TAU plus MBCT)
Time frame: up to 18 months
Subjective well-being measured with the SWEMWBS questionnaire
Comparing overall score on the SWEMWBS before and after the intervention as well as 6 and 18 months after the intervention for both the control group (TAU) and the intervention group (TAU plus MBCT)
Time frame: up to 18 months
Change in use of antidepressants
Self reported use of antidepressants in a questionnaire sent out by the study organization
Time frame: up to 18 months
Change in use of anxiolytics
Self reported use of antidepressants in a questionnaire sent out by the study organization
Time frame: up to 18 months
Plan to share: Yes — There is a plan to make IPD and related data dictionaries available to other researchers when requested. We will be willing to share the below mentioned IPD.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The IPD and additional data will be shared at the time when the summary data are published or otherwise made available and will be available for 5 years after the end of the study.
Access criteria: The study protocol, SAP, ICF, CSR and analytic code can be available for relevant researches, working on similar studies or researchers who want to reproduce the protocol and set up of the study as well as for doing a meta-analysis on similar studies. This must be done in the timeframe mentioned above. The group working on this project (the PhD students consult group) will review the requests and make shared decision on that and as well as decide how it will be shared.
Ran from Sep 2017 to primary completion in Nov 2019, 25 months.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 25 months is above that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University of Iceland