Efficacy of Mindfulness Based Cognitive Therapy on Anxiety in Children
Last registered on December 26, 2014

Pre-Trial

Trial Information
General Information
Title
Efficacy of Mindfulness Based Cognitive Therapy on Anxiety in Children
RCT ID
AEARCTR-0000594
Initial registration date
December 26, 2014
Last updated
December 26, 2014 12:58 AM EST
Location(s)
Region
Primary Investigator
Affiliation
KMC Manipal
Other Primary Investigator(s)
Additional Trial Information
Status
On going
Start date
2014-09-09
End date
2015-06-16
Secondary IDs
Abstract
Anxiety is a condition of persistent and uncontrollable nervousness, stress, and worry that is triggered by anticipation of future events, memories of past events, or ruminations over day-to-day events, both trivial and major, with disproportionate fears of catastrophic consequences” American Psychological Association (2003). Individuals with anxiety experience emotions more easily, quickly and intensely thus affecting all stages of emotional processing (Mennin et al, 2006). It then becomes a challenge for these children as anxiety constantly affects their academic with learning disability, educational under achievement and social functioning (Swanson & Howell, 1996, Wine, 1971, 1982, McLoone, Hudson, & Rapee, 2006, Spurgaitis, 2006). Studies have found that Mindfulness leads to significant decreases in anxiety and increase in the ability to pay attention to stimuli in a non-threatening manner (Napoli, Krech & Holley, 2005) along with improved well-being, calmness, relaxation, improved sleep, less reactivity, increased self-care, self-awareness Wall (2005) and it also allows for enhanced level exposure and acceptance of emotions for children with anxiety Semple & Lee (2011). The present study is aimed at applying Mindfulness based Cognitive therapy on children with anxiety.
External Link(s)
Registration Citation
Citation
Shetty, Rima. 2014. "Efficacy of Mindfulness Based Cognitive Therapy on Anxiety in Children." AEA RCT Registry. December 26. https://www.socialscienceregistry.org/trials/594/history/3343
Experimental Details
Interventions
Intervention(s)
Intervention Start Date
2015-01-03
Intervention End Date
2015-04-30
Primary Outcomes
Primary Outcomes (end points)
The outcome variables consist of the level of anxiety and improvement in the ability of emotional regulation as measured by the score on Spence Children Anxiety Scale and Emotional Regulation Checklist.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
Experiment with random assignment of the participants to control and experimental group.
Experimental Design Details
Randomization Method
Computer software.
Randomization Unit
Individual randomization wherein all the children who meet the inclusion criteria and are qualified to participate in the study will be randomized into experimental and control group based on the computer generated random table.
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
2 schools
Sample size: planned number of observations
60 students
Sample size (or number of clusters) by treatment arms
30 control group and 30 experimental group
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Institutional Ethics Committee, KMC Manipal
IRB Approval Date
2014-09-09
IRB Approval Number
IEC 472/2014
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers