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Clinical Trials/NCT04806542
NCT04806542
Completed
Not Applicable

A Mindfulness-based Intervention Improves Resilience, Anxiety, Anger and Disruptive Behaviour in Children With Mental Health Problems: A 2-year Follow-up Study

Göteborg University0 sites34 target enrollmentJanuary 29, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Health Issue
Sponsor
Göteborg University
Enrollment
34
Primary Endpoint
Anxiety, depression, anger, disruptive behaviour, self-concept according to Beck Youth Inventories.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The primary aim of this study was to determine whether an 8-week mindfulness-based intervention, called Training for Mindfulness and Resilience (TMR), mitigates moderate mental health symptoms and increases resilience during a 2-year follow-up.

Methods

The participants were 34 schoolchildren in age range of 9-14 years, reporting moderate mental health problems. Participants were randomised into either TMR intervention group (N=22) or control group, receiving best current practice (N=12). The investigators used validated self-rating questionnaires to measure anxiety, depression, anger, disruptive behaviour, self-concept, resilience, stress and mindfulness before treatment with either TMR or control, as well as at 6 months, 1 year and 2 years after treatment period.

Registry
clinicaltrials.gov
Start Date
January 29, 2016
End Date
June 20, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Göteborg University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • F32.0 Mild depressive episode
  • F32.1 Moderate depressive episode
  • F41 Anxiety disorders
  • F43 Reactions to stress
  • F51 Nonorganic sleep disorders
  • F93 Emotional disorders with onset specific to childhood
  • F94.8 Other childhood disorders of social functioning
  • F94.9 Other childhood disorder of social functioning, unspecified

Exclusion Criteria

  • Ongoing treatment for severe psychiatric disorders (F20-29, F31-F33.3)
  • Cognitive disorders
  • Difficulties in understanding Swedish
  • Neuropsychiatric considerations and diagnosis
  • Learning disabilities with difficulties in verbal understanding
  • Ongoing parental conflict in conjunction with separation/divorce.
  • Attending less than 5 of the 8 sessions of the TMR program.

Outcomes

Primary Outcomes

Anxiety, depression, anger, disruptive behaviour, self-concept according to Beck Youth Inventories.

Time Frame: Change from Baseline anxiety, depression, anger, disruptive behaviour and self-concept at 2 years.

The investigators used validated self-rating questionnaires called Beck Youth Inventories. Maximum score 300, minimum score 0. Higher values indicate worse outcome except on subscale measuring self-concept where higher score indicate better outcome .

Resilience.

Time Frame: Change from Baseline Resilience at 2 years.

The investigators used a validated self-rating questionnaire called Resilience Scale 10. Maximum score 40, minimum score 10. Higher values indicate better outcome.

Stress.

Time Frame: Change from Baseline stress at 2 years.

The investigators used a validated self-rating questionnaire called Stress in Children. Maximum score 92, minimum score 23. Higher values indicate better outcome.

Mindfulness.

Time Frame: Change from Baseline mindfulness at 2 years.

The investigators used a validated self-rating questionnaire called Child and Adolescent Mindfulness Measure (CAMM). Maximum score 40, minimum score 0. Higher values indicate better outcome.

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