| CTRI Number |
CTRI/2024/10/075281 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Enhancing Para-Athletes Performance and Recovery with Cognitive Behavioral Therapy Before and After Competitions- RCT |
|
Scientific Title of Study
|
Cognitive Behavioral
Therapys
Impact on
Pre-and Post-
Competition Adaptions in
Para-athletes
for Enhanced
Performance
and Psychological
Restoration
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Geetanjali Saggar |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Department of physiotherapy, Lovely Professional University, Jalandhar- Delhi, Grand trunk road, Phagwara
Punjab, 144001
Punjab, 144001
Jalandhar
PUNJAB
144001
India |
| Phone |
8427509407 |
| Fax |
|
| Email |
geetanjalisaggar11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Muskaan Sharma |
| Designation |
Student |
| Affiliation |
Lovely Professional University |
| Address |
Department of physiotherapy, Lovely Professional University, Jalandhar- Delhi, Grand trunk road, Phagwara
Punjab, 144001
Jalandhar
PUNJAB
144001
India |
| Phone |
7347074663 |
| Fax |
|
| Email |
muskaanshxrma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Geetanjali Saggar |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Department of physiotherapy, Lovely Professional University, Jalandhar- Delhi, Grand trunk road, Phagwara
Punjab, 144001
Punjab, 144001
Jalandhar
PUNJAB
144001
India |
| Phone |
8427509407 |
| Fax |
|
| Email |
geetanjalisaggar11@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lovely professional University |
| Address |
School of allied medical sciences, lovely professional University, Phagwara, Punjab,144411 |
| Type of Sponsor |
Other [Private university ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Muskaan Sharma |
Department of Physiotherapy, Lovely Professional University, Phagwara |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Geetanjali Saggar |
Lovely Professional University |
Room no. 309, department of physiotherapy,School of allied medical sciences,LPU, Jalandhar- Delhi, Grand trunk road, Phagwara
144411
Jalandhar
PUNJAB |
8427509407
geetanjalisaggar11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F430||Acute stress reaction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Behavioral Therapy with conventional therapy. |
Total intervention duration is 3 months. |
| Comparator Agent |
Conventional therapy |
Conventional physiotherapy is a traditional approach to treating physical impairments and disabilities through established techniques. It includes manual therapy for pain relief and mobility, exercise therapy to strengthen muscles and improve function, and electrotherapy for pain management. Additionally, it emphasizes patient education on body mechanics and lifestyle changes to support recovery and prevent future issues. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients facing performance-related psychological issues like stress, anxiety, or self-doubt.
Competed in events under official sanction at least once a year.
Participants engaged in para-sports across various disciplines, including but not limited to wheelchair basketball, para-swimming, para-athletics, para-cycling, para-table tennis, and para-badminton. Consented participants.
|
|
| ExclusionCriteria |
| Details |
1.Severe cognitive impairment.
2.Substance abuse problems.
3.Psychosis.
4.Medications of depression or psychosis.
5.Pregnant individuals.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cognitive Therapy Rating Scale (CTRS-R)
State-Trait Anxiety Inventory (STAI)
Overall Anxiety Severity and Impairment Scale (OASIS)
CUDOS Depression Scale |
30.60.90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cognitive Therapy Rating Scale (CTRS-R)
State-Trait Anxiety Inventory (STAI)
Overall Anxiety Severity and Impairment Scale (OASIS)
CUDOS Depression Scale |
30,60,90 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Para athletes, also known as Paralympic athlete, are individuals who participate in sports and athletic competitions specifically created for people with physical, intellectual, or visual impairments. Cognitive behavioural therapy (CBT) is a proactive, time-limited approach aimed at alleviating emotional distress and enhancing adaptive behaviour in individuals with various mental health issues . Cognitive-behavioral therapy (CBT) is crucial for para-athletes, as it helps address their unique psychological challenges arising from adapting to disabilities, societal perceptions, and performance pressures. Studying the effects of CBT can provide valuable insights into tailored interventions that boost mental resilience, coping mechanisms, and overall well-being, thereby enhancing performance in para-sports. This research supports a more inclusive and equitable sports environment by acknowledging and meeting the specific mental health needs of para-athletes. This study has profound implications for the well-being and performance of para-athletes. To assess the baseline psychological challenges faced by para-athletes in their sporting journey, with a focus on performance anxiety, stress management, and emotional well-being. Exploring the effects of cognitive-behavioral therapy (CBT) not only tackles the distinctive psychological hurdles these athletes encounter but also opens avenues for specific interventions to bolster mental resilience, coping skills, and overall psychological health. By delving into how CBT can enhance pre-competition adjustments, the study aids in crafting tailored support mechanisms, fostering inclusivity and fairness in sports, and enhancing the overall athletic journey for para-athletes. |