Clinical DepressionNCT06620445
Efficacy of Psychological Intervention for Children With Cancer
A study testing Interventiion or CBT Group in people with Clinical Depression and Clinical Anxiety, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
The study will be conductued at the Pediatric Oncology Department of the Children's Hospital, PIMS Islamabad, over the peroid of six months. This single-blinded, two-arm RCT study will involve 80 children aged 8 to 16 years with maligancies recieving chemotherapy. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Clinical Depression, Clinical Anxiety, Quality of Life
- What is being tested?
- Interventiion or CBT Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Oct 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 16-18 years
- Diagnosed with malignancy
- Recieving chemotherapy at the Pediatric Oncology Department of PIMS Islamabad
- Able to understand and participate in CBT sessions
- Parent/Caregiver consent and child assent
- Exlusion Criteria:
Show all 9Show fewer
- Children with severe cognitive impairment or intellectual disability
- Children with a comorbid medical conditions
- Children whose parents or caregivers are unable to provide consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Muhammad Wasim Khan
Islamabad, 44000
Muhammad Wasim Khan, MBBS, FCPS, 03334411620, mail4wasimkhan@gmail.com
Nuzhat Yasmeen, MBBS, FCPS, DPH, PhD, 03332135791, drnuzhatyasmeen@yahoo.com
About this study
Official title: Efficacy of Psychological Intervention for Children With Cancer: A Randomized Controlled Trail
The study will be conductued at the Pediatric Oncology Department of the Children's Hospital, PIMS Islamabad, over the peroid of six months. This single-blinded, two-arm RCT study will involve 80 children aged 8 to 16 years with maligancies recieving chemotherapy. Participants will be randomly allocated to either interventional or CBT group which will recieve weekly five sessions of Cognitive Behaviour Therapy (CBT) or the control group, which will recieve the usual care. CBT session will be contducted by Clinical Psychologist will last 30-35 minutes. Outcomes will be measured at Baseine and one month post intervention using Revised Child Anxiety and Depression Scale (RCADS) and Pediatric Quality of Life Generic Core Score 4.0.
Read the detailed description
Background:
Children with cancer and their families experience various psychosocial challenges during and after treatment, including physical and cognitive changes due to medical treatment, alterations in social and familial roles, and the potential threat of death.
While most children and families cope and adjust well to the diagnosis and treatment of cancer, a subset of children is at increased risk for anxiety, depression, educational, and relationship difficulties. Caregivers and siblings of pediatric patients are also at risk for heightened distress and post-traumatic stress. Psychosocial care and interventions can play an important role in supporting the well-being of the entire family, beginning at diagnosis.
The psychological impact of cancer on Pakistani children is diverse and far-reaching, ranging from concerns about their future to worries about appearing different from their peers. Given the high prevalence of psychological difficulties among pediatric cancer patients in Pakistan, it is essential to determine the effectiveness of interventions offered to support their mental health and well-being. Studies on cancer patients related to their psychiatric problems are already rare in Pakistan.
Objective:
The main objective of this study is to compare the effect of psychological intervention, such as cognitive-behavioral therapy (CBT), to the routine care given among pediatric oncology patients. The findings of this study will provide evidence to support the integration of psychological intervention strategies into pediatric oncology practice, thus adding new knowledge to the literature and helping improve the care of children with malignancies receiving chemotherapy.
Study Design:
The study will be conducted at the Pediatric Oncology Unit, PIMS, Islamabad. This study will be a two-armed longitudinal, randomized control trial expected to run for six months. Children with malignancy receiving chemotherapy will be recruited and randomly assigned to experimental or control groups.
Intervention:
The experimental group will receive five sessions of cognitive-behavioral intervention, where maladaptive thoughts and behavior will be identified, behavioral activation will be encouraged, and deep breathing exercises will be practiced. The control group will receive the usual care.
Recruitment and Sample:
The recruitment process will involve the random selection of children diagnosed with malignancies and undergoing treatment at the Pediatric Oncology Unit, the Children's Hospital PIMS Islamabad, Pakistan.
Outcome Measures:
The outcomes will be measured at baseline, post-intervention, and one month after the intervention using the Revised Child Anxiety and Depression Scale and Pediatric Quality of Life Inventory Generic Core Score 4.0.
Data Analysis:
Data analysis will be conducted using SPSS version 23.
Ethical Considerations:
Permission to conduct the study will be acquired from the Ethical Review Board (ERB) of PIMS Islamabad.
- Conditions
- Clinical Depression, Clinical Anxiety, Quality of Life
- Being tested
- Interventiion or CBT Group
- Keywords
- Psychological Intervention, Pediatric Cancer
- Medical subject headings
- Depressive Disorder, Major, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventiion or CBT GroupBehavioural
Also called Cognitive or Pschological Intervention
This RCT aims to evaluate the effect of Cognitive Behavioral Therapy (CBT) compared to usual care (UC) in pediatric oncology patients. We hypothesize that those receiving CBT will report lower depression and anxiety and improved QoL six months post-enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | The Intervention or CBT group included 40 children aged 8-16 years with malignancies recieving chemotherapy. They will recieve weekly five sessions of CBT (30-35 minutes per session) Receives: Behavioral: Interventiion or CBT Group |
| Control or Usual Care Group | No intervention | The Control or No Intervention Group also known as Comparision Group or Usual Group will recieve the standard care or usual care for their condition. It will serve as a baseline for the CBT or Intervention Group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Child Anxiety and Depression Scale (RCADS)
The RCADS is a standardized, self reported scale measuring anxiety and depression symptoms among children aged 8-18 years.
Measured: Baseline (before the intervention) and one month post intervention (after the five weekly sessions of CBT)
Secondary outcomes (1)
Pediatric QoL
It evaluates physical, emotional, social and school funtioning.
Measured: Baseline and one month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Oct 2024 (estimated)
- Primary completion10 Feb 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This single-blinded, two-arm randomized controlled trial will involve 80 children aged 8-16 with malignancies receiving chemotherapy. Participants will be randomly assigned to either the experimental group, which will receive five weekly sessions of cognitive-behavioral intervention, or the control group, which will receive usual care. Each intervention session will last 30-35 minutes. Outcomes will be measured at baseline and one-month post-intervention using the Revised Child Anxiety and Depression Scale and Pediatric Quality of Life Inventory Generic Core Score 4.0.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Muhammad Wasim Khan, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620445
- Sponsor's protocol ID
- F.1-1/2015/ERBSZABMU/1311
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Demographic, Clinical and Treatment related Information of the Participants
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Psychological Intervention for Children With Cancer: A Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT06620445
- Acronym / sponsor ID
- F.1-1/2015/ERBSZABMU/1311
- Conditions
- Clinical Depression, Clinical Anxiety, Quality of Life
- Keywords
- Psychological Intervention, Pediatric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 10 Feb 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be conductued at the Pediatric Oncology Department of the Children's Hospital, PIMS Islamabad, over the peroid of six months. This single-blinded, two-arm RCT study will involve 80 children aged 8 to 16 years with maligancies recieving chemotherapy. Participants will be randomly allocated to either interventional or CBT group which will recieve weekly five sessions of Cognitive Behaviour Therapy (CBT) or the control group, which will recieve the usual care. CBT session will be contducted by Clinical Psychologist will last 30-35 minutes. Outcomes will be measured at Baseine and one month post intervention using Revised Child Anxiety and Depression Scale (RCADS) and Pediatric Quality of Life Generic Core Score 4.0.
Detailed description
Background:
Children with cancer and their families experience various psychosocial challenges during and after treatment, including physical and cognitive changes due to medical treatment, alterations in social and familial roles, and the potential threat of death.
While most children and families cope and adjust well to the diagnosis and treatment of cancer, a subset of children is at increased risk for anxiety, depression, educational, and relationship difficulties. Caregivers and siblings of pediatric patients are also at risk for heightened distress and post-traumatic stress. Psychosocial care and interventions can play an important role in supporting the well-being of the entire family, beginning at diagnosis.
The psychological impact of cancer on Pakistani children is diverse and far-reaching, ranging from concerns about their future to worries about appearing different from their peers. Given the high prevalence of psychological difficulties among pediatric cancer patients in Pakistan, it is essential to determine the effectiveness of interventions offered to support their mental health and well-being. Studies on cancer patients related to their psychiatric problems are already rare in Pakistan.
Objective:
The main objective of this study is to compare the effect of psychological intervention, such as cognitive-behavioral therapy (CBT), to the routine care given among pediatric oncology patients. The findings of this study will provide evidence to support the integration of psychological intervention strategies into pediatric oncology practice, thus adding new knowledge to the literature and helping improve the care of children with malignancies receiving chemotherapy.
Study Design:
The study will be conducted at the Pediatric Oncology Unit, PIMS, Islamabad. This study will be a two-armed longitudinal, randomized control trial expected to run for six months. Children with malignancy receiving chemotherapy will be recruited and randomly assigned to experimental or control groups.
Intervention:
The experimental group will receive five sessions of cognitive-behavioral intervention, where maladaptive thoughts and behavior will be identified, behavioral activation will be encouraged, and deep breathing exercises will be practiced. The control group will receive the usual care.
Recruitment and Sample:
The recruitment process will involve the random selection of children diagnosed with malignancies and undergoing treatment at the Pediatric Oncology Unit, the Children's Hospital PIMS Islamabad, Pakistan.
Outcome Measures:
The outcomes will be measured at baseline, post-intervention, and one month after the intervention using the Revised Child Anxiety and Depression Scale and Pediatric Quality of Life Inventory Generic Core Score 4.0.
Data Analysis:
Data analysis will be conducted using SPSS version 23.
Ethical Considerations:
Permission to conduct the study will be acquired from the Ethical Review Board (ERB) of PIMS Islamabad.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This single-blinded, two-arm randomized controlled trial will involve 80 children aged 8-16 with malignancies receiving chemotherapy. Participants will be randomly assigned to either the experimental group, which will receive five weekly sessions of cognitive-behavioral intervention, or the control group, which will receive usual care. Each intervention session will last 30-35 minutes. Outcomes will be measured at baseline and one-month post-intervention using the Revised Child Anxiety and Depression Scale and Pediatric Quality of Life Inventory Generic Core Score 4.0.
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Behavioral: Interventiion or CBT GroupThe Intervention or CBT group included 40 children aged 8-16 years with malignancies recieving chemotherapy. They will recieve weekly five sessions of CBT (30-35 minutes per session) |
| Control or Usual Care Group | No intervention | –The Control or No Intervention Group also known as Comparision Group or Usual Group will recieve the standard care or usual care for their condition. It will serve as a baseline for the CBT or Intervention Group. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children aged 16-18 years
- Diagnosed with malignancy
- Recieving chemotherapy at the Pediatric Oncology Department of PIMS Islamabad
- Able to understand and participate in CBT sessions
- Parent/Caregiver consent and child assent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventiion or CBT GroupAlso: Cognitive or Pschological InterventionThis RCT aims to evaluate the effect of Cognitive Behavioral Therapy (CBT) compared to usual care (UC) in pediatric oncology patients. We hypothesize that those receiving CBT will report lower depression and anxiety and improved QoL six months post-enrollment. | Behavioural | Interventional Group |
Primary outcome
Revised Child Anxiety and Depression Scale (RCADS)
Time frame: Baseline (before the intervention) and one month post intervention (after the five weekly sessions of CBT)
The RCADS is a standardized, self reported scale measuring anxiety and depression symptoms among children aged 8-18 years.
1 secondary outcome
Pediatric QoL
Time frame: Baseline and one month post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No. Demographic, Clinical and Treatment related Information of the Participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventiion or CBT Group in people with Clinical Depression and Clinical Anxiety, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Child Anxiety and Depression Scale (RCADS) (time frame: Baseline (before the intervention) and one month post intervention (after the five weekly sessions of CBT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.