Depression, AnxietyNCT03272516
Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients
A study testing Mindfulness based cognitive therapy (MBCT) and Treatment as usual (TAU) in people with Depression, Anxiety, run by University of Iceland at 2 sites in Iceland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Mindfulness based cognitive therapy (MBCT) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesIceland
- Study dates
- 12 Sep 2017to 21 Oct 2020
- 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 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PHQ-9 and GAD-7 score 5-14 points
- Age18 - 67
- No current/recent psychotherapy of any kind other than his/hers physicians therapy( can be taking antidepressants but not in CBT)
- No regular meditation or yoga practice
- Not mentally retarded
- Speaks and understands Icelandic
Show all 9Show fewer
- No current substance dependence
- Not diagnosed with schizophrenic symptoms or bipolar disease that that currently requires treatment
- Not participating in another mental health study
Who cannot join
- Age: <18 and >67 years old.
- Severe psychiatric symptoms requiring psychiatric care
- Risk of suicide
- Inability to participate in group sessions because of severe substance misuse;
- Inability to speak and understand Icelandic
- Pregnancy;
Show all 13Show fewer
- Current psychotherapy of any kind;
- Participation in any other psychiatric intervention study;
- Thyroid disease (if newly diagnosed by the doctor).
- Score under 5 on both GAD7 and PHQ-9 and score over 14 on either GAD7 or PHQ-9.
- One or more of the following ICD-10 psychiatric diagnoses:
- 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
- -
Trial locations and contacts
2 sites in 1 country.
Iceland2 sites
Heilsugæslan Grafarvogi
Reykjavik, Grafarvogur, 112
Heilsugæslan Miðbæ
Reykjavik, 101
About this study
Official title: Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients With Mild to Moderate Symptoms of Depression or Anxiety.
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
Read the detailed description
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.
- Conditions
- Depression, Anxiety
- Being tested
- Mindfulness based cognitive therapy (MBCT), Treatment as usual (TAU)
- Keywords
- Mild to moderate Depression, Mild to moderate Anxiety, Mindfulness based cognitive therapy, Primary care, PHQ-9, GAD-7, Antidepressants, Anxiolytica, Subjective wellbeing
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based cognitive therapy (MBCT)Behavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Treatment as usual (TAU) |
| 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.. Receives: Behavioral: Mindfulness based cognitive therapy (MBCT); Other: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: up to 18 months
Secondary outcomes (3)
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)
Measured: up to 18 months
Change in use of antidepressants
Self reported use of antidepressants in a questionnaire sent out by the study organization
Measured: up to 18 months
Change in use of anxiolytics
Self reported use of antidepressants in a questionnaire sent out by the study organization
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start12 Sep 2017
- Primary completion10 Nov 2019
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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: 1. Increasing subjective wellbeing 2. Reducing antidepressant/anxiolytica use for primary care patients, with mild to moderate symptoms of depression and/or anxiety.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Svala Sigurdardottir, University of Iceland
- Investigators
- Dóra G Gudmundsdóttir, PhD, Study chair, Directorate of Health, Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272516
- Sponsor's protocol ID
- UI-2017-MBCT.
- Status last verified
- Nov 2020
- First submitted
- 31 Aug 2017
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 17457848Stirman 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.
PubMed 22426739Bondolfi G, Jermann F, der Linden MV, Gex-Fabry M, Bizzini L, Rouget BW, Myers-Arrazola L, Gonzalez C, Segal Z, Aubry JM, Bertschy G. Depression relapse prophylaxis with Mindfulness-Based Cognitive Therapy: replication and extension in the Swiss health care system. J Affect Disord. 2010 May;122(3):224-31. doi: 10.1016/j.jad.2009.07.007. Epub 2009 Aug 8.
PubMed 19666195Thimm JC, Antonsen L. Effectiveness of cognitive behavioral group therapy for depression in routine practice. BMC Psychiatry. 2014 Oct 21;14:292. doi: 10.1186/s12888-014-0292-x.
PubMed 25330912Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Demarzo MM, Montero-Marin J, Cuijpers P, Zabaleta-del-Olmo E, Mahtani KR, Vellinga A, Vicens C, Lopez-del-Hoyo Y, Garcia-Campayo J. The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review. Ann Fam Med. 2015 Nov;13(6):573-82. doi: 10.1370/afm.1863.
PubMed 26553897Dimidjian S, Segal ZV. Prospects for a clinical science of mindfulness-based intervention. Am Psychol. 2015 Oct;70(7):593-620. doi: 10.1037/a0039589.
PubMed 26436311Fernandez E, Salem D, Swift JK, Ramtahal N. Meta-analysis of dropout from cognitive behavioral therapy: Magnitude, timing, and moderators. J Consult Clin Psychol. 2015 Dec;83(6):1108-22. doi: 10.1037/ccp0000044. Epub 2015 Aug 24.
PubMed 26302248Fjorback LO, Arendt M, Ornbol E, Walach H, Rehfeld E, Schroder A, Fink P. Mindfulness therapy for somatization disorder and functional somatic syndromes: randomized trial with one-year follow-up. J Psychosom Res. 2013 Jan;74(1):31-40. doi: 10.1016/j.jpsychores.2012.09.006. Epub 2012 Oct 1.
PubMed 23272986Godfrin KA, van Heeringen C. The effects of mindfulness-based cognitive therapy on recurrence of depressive episodes, mental health and quality of life: A randomized controlled study. Behav Res Ther. 2010 Aug;48(8):738-46. doi: 10.1016/j.brat.2010.04.006. Epub 2010 Apr 18.
PubMed 20462570de Graaf R, Bijl RV, Spijker J, Beekman AT, Vollebergh WA. Temporal sequencing of lifetime mood disorders in relation to comorbid anxiety and substance use disorders--findings from the Netherlands Mental Health Survey and Incidence Study. Soc Psychiatry Psychiatr Epidemiol. 2003 Jan;38(1):1-11. doi: 10.1007/s00127-003-0597-4.
PubMed 12563553Gu J, Strauss C, Crane C, Barnhofer T, Karl A, Cavanagh K, Kuyken W. Examining the factor structure of the 39-item and 15-item versions of the Five Facet Mindfulness Questionnaire before and after mindfulness-based cognitive therapy for people with recurrent depression. Psychol Assess. 2016 Jul;28(7):791-802. doi: 10.1037/pas0000263. Epub 2016 Apr 14.
PubMed 27078186Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.
PubMed 20350028Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31.
PubMed 23459093Hofmeijer-Sevink MK, Batelaan NM, van Megen HJ, Penninx BW, Cath DC, van den Hout MA, van Balkom AJ. Clinical relevance of comorbidity in anxiety disorders: a report from the Netherlands Study of Depression and Anxiety (NESDA). J Affect Disord. 2012 Mar;137(1-3):106-12. doi: 10.1016/j.jad.2011.12.008. Epub 2012 Jan 10.
PubMed 22240085
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients With Mild to Moderate Symptoms of Depression or Anxiety.
- ClinicalTrials.gov ID
- NCT03272516
- Acronym / sponsor ID
- UI-2017-MBCT.
- Conditions
- Depression, Anxiety
- Keywords
- Mild to moderate Depression, Mild to moderate Anxiety, Mindfulness based cognitive therapy, Primary care, PHQ-9, GAD-7, Antidepressants, Anxiolytica
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 5 Sep 2017 (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 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
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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: 1. Increasing subjective wellbeing 2. Reducing antidepressant/anxiolytica use for primary care patients, with mild to moderate symptoms of depression and/or anxiety.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Treatment as usual (TAU)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 | 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.. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- PHQ-9 and GAD-7 score 5-14 points
- Age18 - 67
- No current/recent psychotherapy of any kind other than his/hers physicians therapy( can be taking antidepressants but not in CBT)
- No regular meditation or yoga practice
- Not mentally retarded
Key exclusion criteria (13 listed)
- Age: <18 and >67 years old.
- Severe psychiatric symptoms requiring psychiatric care
- Risk of suicide
- Inability to participate in group sessions because of severe substance misuse;
- Inability to speak and understand Icelandic
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 cognitive therapy (MBCT)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. | Behavioural | Intervention group |
| Treatment as usual (TAU)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. | Other | Control group, Intervention group |
Primary outcome
Symptoms of depression measured with the PHQ-9 questionnaire
Time frame: up to 18 months
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)
Symptoms of anxiety measured with the GAD-7 questionnaire
Time frame: up to 18 months
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)
3 secondary outcomes
Subjective well-being measured with the SWEMWBS questionnaire
Time frame: up to 18 months
Change in use of antidepressants
Time frame: up to 18 months
Change in use of anxiolytics
Time frame: up to 18 months
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 4 Nov 2020.
- Background: PubMed 17457848Bados 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.
- Background: PubMed 22426739Stirman 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.
- Background: PubMed 19666195Bondolfi G, Jermann F, der Linden MV, Gex-Fabry M, Bizzini L, Rouget BW, Myers-Arrazola L, Gonzalez C, Segal Z, Aubry JM, Bertschy G. Depression relapse prophylaxis with Mindfulness-Based Cognitive Therapy: replication and extension in the Swiss health care system. J Affect Disord. 2010 May;122(3):224-31. doi: 10.1016/j.jad.2009.07.007. Epub 2009 Aug 8.
- Background: PubMed 25330912Thimm JC, Antonsen L. Effectiveness of cognitive behavioral group therapy for depression in routine practice. BMC Psychiatry. 2014 Oct 21;14:292. doi: 10.1186/s12888-014-0292-x.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 26553897Demarzo MM, Montero-Marin J, Cuijpers P, Zabaleta-del-Olmo E, Mahtani KR, Vellinga A, Vicens C, Lopez-del-Hoyo Y, Garcia-Campayo J. The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review. Ann Fam Med. 2015 Nov;13(6):573-82. doi: 10.1370/afm.1863.
- Background: PubMed 26436311Dimidjian S, Segal ZV. Prospects for a clinical science of mindfulness-based intervention. Am Psychol. 2015 Oct;70(7):593-620. doi: 10.1037/a0039589.
- Background: PubMed 26302248Fernandez E, Salem D, Swift JK, Ramtahal N. Meta-analysis of dropout from cognitive behavioral therapy: Magnitude, timing, and moderators. J Consult Clin Psychol. 2015 Dec;83(6):1108-22. doi: 10.1037/ccp0000044. Epub 2015 Aug 24.
- Background: PubMed 23272986Fjorback LO, Arendt M, Ornbol E, Walach H, Rehfeld E, Schroder A, Fink P. Mindfulness therapy for somatization disorder and functional somatic syndromes: randomized trial with one-year follow-up. J Psychosom Res. 2013 Jan;74(1):31-40. doi: 10.1016/j.jpsychores.2012.09.006. Epub 2012 Oct 1.
- Background: PubMed 20462570Godfrin KA, van Heeringen C. The effects of mindfulness-based cognitive therapy on recurrence of depressive episodes, mental health and quality of life: A randomized controlled study. Behav Res Ther. 2010 Aug;48(8):738-46. doi: 10.1016/j.brat.2010.04.006. Epub 2010 Apr 18.
- Background: PubMed 12563553de Graaf R, Bijl RV, Spijker J, Beekman AT, Vollebergh WA. Temporal sequencing of lifetime mood disorders in relation to comorbid anxiety and substance use disorders--findings from the Netherlands Mental Health Survey and Incidence Study. Soc Psychiatry Psychiatr Epidemiol. 2003 Jan;38(1):1-11. doi: 10.1007/s00127-003-0597-4.
- Background: PubMed 27078186Gu J, Strauss C, Crane C, Barnhofer T, Karl A, Cavanagh K, Kuyken W. Examining the factor structure of the 39-item and 15-item versions of the Five Facet Mindfulness Questionnaire before and after mindfulness-based cognitive therapy for people with recurrent depression. Psychol Assess. 2016 Jul;28(7):791-802. doi: 10.1037/pas0000263. Epub 2016 Apr 14.
- Individual participant dataSharing planned: 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.
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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.
Dóra G Gudmundsdóttir, PhD study chair
Directorate of Health, Iceland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based cognitive therapy (MBCT) and Treatment as usual (TAU) in people with Depression, Anxiety, run by University of Iceland at 2 sites in Iceland.
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 9 inclusion and 13 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 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iceland. 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?
Symptoms of depression measured with the PHQ-9 questionnaire (time frame: up to 18 months). The study lists 2 primary outcomes in all. 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 NCT03272516, which also lists 45 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 4 Nov 2020.