Thalassemia in the adolescent population Circulatory System Thalassemia in the adolescent population
Conditions
Interventions
Participants are randomly allocated to either the intervention or the control group using random number sequences.
The intervention group will receive cognitive behavioral therapy (CBT
Sponsors
Universiti Putra Malaysia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 22/02/2019: 1. Registered at the thalassemia day care center of their hospital 2. Confirmed diagnosis of thalassemia major 3. Aged 13-17 years 4. On regular blood transfusion 5. On iron chelation therapy 6. Beck Depression Inventory score >21 7. Beck Anxiety Inventory score >16 8. Able to read and write in English and Malay languages Previous inclusion criteria: 1. Registered at the thalassemia day care center of their hospital 2. Confirmed diagnosis of thalassemia major 3. Aged 11-17 years 4. On regular blood transfusion 5. On iron chelation therapy 6. Beck Depression Inventory score >21 7. Beck Anxiety Inventory score >16 8. Able to read and write in English and Malay languages
Exclusion criteria
Exclusion criteria: 1. On medication for anxiety and/or depression 2. Anxiety and/or depression due to other medical illness 3. Exposure to cognitive behavioral therapy and/or counseling and/or psychological therapy 4. Co-morbidity (not due to thalassemia, blood transfusion or iron chelation therapy complications), including cancer, young hypertension, epilepsy, asthma 5. Illiterate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short and long-term effectiveness of cognitive behavioral therapy (CBT) and treatment as usual (TAU) compared to treatment as usual (TAU), assessed using the following at the baseline, immediately post-intervention, and 1, 3 and 6 months post-intervention: 1. Beck Anxiety Inventory (BAI) 2. Beck Depression Inventory (BDI) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following are assessed at the baseline, immediately post-intervention, and 1, 3 and 6 months post-intervention: 1. Thalassemia knowledge, assessed using a questionnaire including: 1.1. 5 items on general knowledge of thalassemia 1.2. 10 items on knowledge of thalassemia major 1.3. 6 items on knowledge of thalassemia minor 1.7. 2 items on knowledge of prevention of thalassemia major 2. The following clinical parameters, collected by self-report from participants and through medical records: 2.1. Age of first diagnosis 2.2. Type of thalassemia 2.3. Age of first blood transfusion 2.4. Frequency of blood transfusion 2.5. Age of first iron chelation therapy 2.6. Type of chelation 2.7. Number of siblings with thalassemia 2.8. Latest pre-transfusion hemoglobin level 2.9. Latest serum ferritin level 2.10. Presence of hepatomegaly and splenomegaly 3. Satisfaction, assessed using the Satisfaction with ICT questionnaire (SICT) 4. Adherence, assessed using the Satisfaction with ICT questionnaire (SICT) 5. Persistence to iron chelation therapy treatment, assessed using the Satisfaction with ICT questionnaire (SICT) 6. Quality of life among adolescents with thalassemia, assessed using the PedsQL 4.0 questionnaire 7. Response rate, assessed by the total numbers of participant return and completion of the questionnaire at all timepoints in comparison with the number of participants assigned to each arms 8. Remission/relapses of anxiety and depression, assessed using the total score of the BAI and BDI at all timepoints post-intervention compared to these scores at the baseline 9. Attrition from the intervention, asses | — |
Countries
Malaysia
Contacts
Public Contactdayangku hayaty dzulkarnain
Outcome results
None listed