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Field
Trial Status
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Before
in_development
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After
completed
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Field
Abstract
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Before
Anxiety is highly prevalent among adolescents, which can lead to serious problems in adulthood if left untreated. The global prevalence of anxiety disorders among children and adolescents is found to be 6.5%. As per the National Institutes of Health, over one-third of all adolescents between the ages of 13 and 18 will suffer from anxiety. Despite the existence of various treatments, this goes unrecognized and untreated. This highlights the critical need for indigenous, evidence-based intervention to promptly address these risk factors. Thus, the present study aims to evaluate the acceptability and feasibility of delivering the cognitive-behavioral therapy-based intervention in a Pakistani school setting. The present study is a single-blind, two arms, feasibility randomized controlled trial which will be conducted in Urban schools of Rawalpindi. A sample of 24, secondary school children, aged 14 -18 years, will be approached from 4 private schools located in Rawalpindi. Initial screening will be carried out and then participants are going to be randomized into the intervention arm and control arm. Participants in the intervention arm will receive cognitive-behavioral therapy. A total of 8 group therapy sessions, each lasting for at least 50-60 minutes will be given. While participants in the control arm will receive no such treatment. The feasibility investigation demonstrates a lower level of anxiety among participants and the acceptability of the design. Results of this feasibility randomized control trial will further be beneficial in the capacity building of teachers who can further identify the risk factors of anxiety and be able to take precautionary measures on time.
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After
Anxiety is highly prevalent among adolescents, which can lead to serious problems in adulthood if left untreated. The global prevalence of anxiety disorders among children and adolescents is found to be 6.5%. As per the National Institutes of Health, over one-third of all adolescents between the ages of 13 and 18 will suffer from anxiety. Despite the existence of various treatments, this goes unrecognized and untreated. This highlights the critical need for indigenous, evidence-based intervention to promptly address these risk factors. Thus, the present study aimed to evaluate the acceptability and feasibility of delivering the cognitive-behavioral therapy-based intervention in a Pakistani school setting. The present study was a single-blind, two arms, feasibility randomized controlled trial which was be conducted in Urban schools of Rawalpindi. A total sample of 34 secondary school children (17 in each arm) with elevated scores of anxiety upon assessment from the four participating schools were included in the study. Randomization was done by an independent researcher. Since it was feasibility research, so no power calculations were performed, but it was ensured that the sample would be sufficient to predict the acceptance, uptake of the intervention, recruitment, and retention rates of participants for a future definitive trial. Primarily, the experimental group received therapy that comprised eight sessions and each session lasting for up to fifty minutes. Results were found to be significant with a reduction in the level of anxiety at post assessment (ηp2= .32) as well as in follow-up when compared to baseline assessment. The intervention had a positive influence on young people, with the primary result being a reduction in anxiety, and the secondary outcomes being increased self-regulation and personal adjustment. Moreover, at the end of the trial, the willing participants of the wait-list control group were also accommodated for therapy. Results of this feasibility randomized control trial will further be beneficial in the capacity building of teachers who can identify the risk factors of anxiety and be able to take precautionary measures in time.
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Last Published
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Before
November 14, 2022 01:55 AM
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After
February 28, 2023 03:42 AM
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Field
Intervention Completion Date
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Before
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After
October 17, 2022
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Field
Data Collection Complete
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Before
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After
Yes
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Final Sample Size: Number of Clusters (Unit of Randomization)
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Before
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After
4 schools.
A total of 34 students were selected for final trial.
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Field
Was attrition correlated with treatment status?
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Before
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After
Yes
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Final Sample Size: Total Number of Observations
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Before
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After
4 schools and 34 students in total.
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Final Sample Size (or Number of Clusters) by Treatment Arms
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Before
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After
17 in experimental arm and 17 in control arm.
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Is there a restricted access data set available on request?
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Before
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After
No
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Program Files
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Before
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After
No
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Data Collection Completion Date
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Before
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After
August 15, 2022
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Is data available for public use?
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Before
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After
No
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Intervention (Public)
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Before
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After
CBT based intervention is used in present study to reduce anxiety among school children. This intervention aimed to alter faulty cognitions that can become the root cause of anxiety in later stages. This intervention includes strategies that help students in following areas:
1. Restructuring faulty cognitions
2. Relaxation techniques
3. Exposure based techniques
4. Self-assessment and management
5. How to prevent relapse.
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Experimental Design (Public)
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Before
Pre-post and follow up/baseline designstratified
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After
Pre-post and follow up/baseline design
stratified
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Planned Number of Observations
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Before
24 students
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After
34 students
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Sample size (or number of clusters) by treatment arms
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Before
12 control, 12 treatment
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After
17 control, 17 treatment
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Intervention (Hidden)
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Before
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After
A group therapy comprising of 8 sessions was conducted specifically for anxiety. Details of each session are listed below:
Session 1:
This session consisted of establishing orientation, rapport building, establishing group rules and expectations.
Session 2:
This session comprised of psychoeducation participants and learning about anxiety. Session was made interactive through videos.
Session 3:
This session focused on restructuring faulty cognitions through various worksheets like thought record form etc. Understanding the concept of Automatic Negative Thoughts (ANTS).
Session 4:
Teaching relaxation based techniques to participants was targeted in this session. Depp breathing and ice-cube challenges were incorporated in the session. Relaxation exercises were demonstrated and practiced in the session multiple times.
Session 5:
This session targeted the concept of exposure and avoidance. Through fear ladder worksheet participants were able to identify and list their fear and rate their anxiety.
Session 6:
Self assessment and management was the prime goal of this session. activities like activity scheduling (form), PACE activity and grounding exercises were taught to participants. Participants were motivated to practice these skills for better outcomes.
Session 7:
Parental guidance and counseling along with contingency management was done in this session. Goal was to educate families about anxiety and how to identify and take precautionary measures timely through 'parental tip sheet'.
Session 8:
Termination and relapse prevention was the goal of this session. Participants were once again psycho-educated about the importance of therapy and entire therapeutic session was summarized.
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Did you obtain IRB approval for this study?
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Before
No
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After
Yes
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Secondary Outcomes (End Points)
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Before
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After
CBT based therapy will also help in improving other emotional behavioral problems as well.
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Secondary Outcomes (Explanation)
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Before
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After
children will learn to channelize their emotions in a healthier and positive way.
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Public locations
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Before
No
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After
Yes
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