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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | 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. |
|
| Intervention group | Experimental | 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.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness based cognitive therapy (MBCT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 18 months |
| Change in use of antidepressants |
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Inclusion Criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Dóra G Gudmundsdóttir, PhD | Directorate of Health, Iceland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heilsugæslan Grafarvogi | Reykjavik | Grafarvogur | 112 | Iceland | ||
| Heilsugæslan Miðbæ |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17457848 | Background | Bados A, Balaguer G, Saldana C. The efficacy of cognitive-behavioral therapy and the problem of drop-out. J Clin Psychol. 2007 Jun;63(6):585-92. doi: 10.1002/jclp.20368. | |
| 22426739 | Background | Stirman SW, Gutierrez-Colina A, Toder K, Esposito G, Barg F, Castro F, Beck AT, Crits-Christoph P. Clinicians' perspectives on cognitive therapy in community mental health settings: implications for training and implementation. Adm Policy Ment Health. 2013 Jul;40(4):274-85. doi: 10.1007/s10488-012-0418-8. |
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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.
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.
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.
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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Randomized clinical trial, where patients are randomized to two groups. Group 1 receives treatment as usual, group 2 receives treatment as usual plus Mindfulness Based Cognitive Therapy (MBCT) for symptoms of mild to moderate depression or anxiety.
Our primary aim is to investigate whether MBCT added to TAU is more effective than TAU alone in reducing mild to moderate symptoms of depression and/or anxiety among primary care patients.
Our secondary aim is to investigate whether MBCT added to TAU is more effective than TAU alone in:
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The investigator will contact all participants in both groups via email or telephone to ask them to answer questionnaires.The investigator will not have information about which group which participant is. Participants will be contacted and invited to answer a questionnaire before, after, 6 and 18 months after 8 weeks of TAU and TAU plus MBCT.
|
| Treatment as usual (TAU) | Other | 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. |
|
Self reported use of antidepressants in a questionnaire sent out by the study organization |
| up to 18 months |
| Change in use of anxiolytics | Self reported use of antidepressants in a questionnaire sent out by the study organization | up to 18 months |
| Reykjavik |
| 101 |
| Iceland |
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| D004191 |
| Behavioral Disciplines and Activities |