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

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
December 26, 2014, 12:58 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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://doi.org/10.1257/rct.594-1.0
Former 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

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials