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Completed

NCT Number: NCT03272516

Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients

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

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Key information

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heilsugæslan Grafarvogi, Reykjavik, Grafarvogur, Iceland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • No current substance dependence
  • Not diagnosed with schizophrenic symptoms or bipolar disease that that currently requires treatment
  • Not participating in another mental health study

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;
  • 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

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Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Subjective well-being measured with the SWEMWBS questionnaire

    Time frame: up to 18 months

    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)

  2. Change in use of antidepressants

    Time frame: up to 18 months

    Self reported use of antidepressants in a questionnaire sent out by the study organization

  3. Change in use of anxiolytics

    Time frame: up to 18 months

    Self reported use of antidepressants in a questionnaire sent out by the study organization

Sponsors and collaborators

Lead sponsor

University of Iceland

Other

Collaborators

  • University of Aarhus

Registry information

Official study title

Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients With Mild to Moderate Symptoms of Depression or Anxiety.

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 5, 2017
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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