CompletedNot Applicable

Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients

Iceland120 participantsStarted 2017-09-12

Plain-language 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. 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

Who can participate

Age range

18 Years – 67 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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;
. Current psychotherapy of any kind;
. Participation in any other psychiatric intervention study;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Symptoms of depression measured with the PHQ-9 questionnaire

Timeframe: up to 18 months

Symptoms of anxiety measured with the GAD-7 questionnaire

Timeframe: up to 18 months

Trial details

NCT IDNCT03272516

SponsorUniversity of Iceland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-10

View on ClinicalTrials.gov More Depression, Anxiety trials