Condition category
Circulatory System
Date applied
19/11/2018
Date assigned
22/11/2018
Last edited
27/11/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Thalassemia is a disease where the individual does not produce enough haemoglobin, which can lead to a variety of symptoms including severe fatigue, anaemia, weakness and shortness of breath. Rates of anxiety and depression amongst thalassemia patients and their caregivers has significantly increased. This has been shown to lead to non-adherence towards blood transfusion and iron chelation therapies amongst adolescents with thalassemia. Cognitive behavioral therapy (CBT) is a therapy for the treatment of anxiety and depression that has been shown to be effective. The aim of this study is to look at the effectiveness of CBT to treat thalassemia-related anxiety and depression.

Who can participate?
People aged 11-17 with thalassemia major

What does the study involve?
Patients will be randomly allocated to one of two groups, the intervention group or the control group. The intervention group will receive a course of CBT over 4 weeks, with one session per week, along with the usual treatment for thalassemia-related anxiety and depression. The control group will receive the usual treatment only. Questionnaires and tests will be completed before the intervention, just after the intervention and 1, 3 and 6 months afterwards.

What are the possible benefits and risks of participating?
Participants may or may not benefit from receiving CBT. The data obtained from this study will help to improve the treatment or management of other participants with the same disease or condition.
There are no known risks to participants taking part in this study. In the case of increased in severity of the symptoms of anxiety and/or depression at any time, patients will leave the study and their case will be managed accordingly.

Where is the study run from?
Four hospitals in Selangor, Malaysia:
1. Hospital Serdang
2. Hospital Ampang
3. Hospital Selayang
4. Hospital Tengku Ampuan Rahimah

When is the study starting and how long is it expected to run for?
December 2018 to May 2019

Who is funding the study?
Fakulti Perubatan dan Sains Kesihatan, Universiti Putra Malaysia (Malaysia)

Who is the main contact?
Dr. Dayangku Hayaty bt Awg Dzulkarnain
yatyadzul@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Dr dayangku hayaty dzulkarnain

ORCID ID

Contact details

Department of Family Medicine
Faculty Of Medicine and Health Sciences
Universiti Putra Malaysia
Serdang
selangor
43400
Malaysia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

41010

Study information

Scientific title

Efficacy of cognitive behavioral therapy on psychological and clinical parameters among adolescents with thalassemia in Selangor: a randomized controlled trial

Acronym

CBT THALASSEMIA

Study hypothesis

1. Cognitive behavioral therapy (CBT) and treatment as usual (TAU) in comparison with treatment as usual (TAU) alone are superior in reducing anxiety and depression among adolescents with thalassemia at short and long-term treatment.
2. There is a significant difference between the effect of CBT and TAU in comparison with TAU alone in improving thalassemia knowledge, clinical parameters, satisfaction, adherence and persistence to iron chelation therapy treatment (SICT) and quality of life among adolescents with thalassemia
3. CBT and TAU in comparison with TAU alone at the 6 month follow-up is superior in increasing the response rate, remission or relapsed of anxiety and depression, and attrition to the intervention.

Ethics approval

National Medical Research Registration Malaysia (waiting for approval after study was revised twice on 26/10/2018), reference number NMRR-18-1311-41010 (IIR)

Study design

Interventional multi-center single-blinded randomised controlled parallel trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please email yatyadzul@gmail.com to request a participant information sheet

Condition

Thalassemia in the adolescent population

Intervention

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) and treatment as usual (TAU). CBT is administered by the primary investigator, with adequate training from an experienced clinical psychologist. The CBT is specifically designed for thalassemia-related anxiety and depression. Participants will receive CBT once per week for at least 45 minutes for 4 weeks. The CBT sessions will focus on biological and psychological aspects of thalassemia, treatment adherence and how to manage thalassemia-related anxiety and depression. The 4 week treatment period may be increased if necessary for scheduling purposes (for example, due to holidays or examination periods) up to 8 weeks.
TAU is provided by the doctors at the day care center of Hospital Ampang, Hospital Selayang, Hospital Serdang and Hospital Tuanku Ampuan Rahimah, Klang, Selangor in their regular consultations. It consists of a face-to-face session with a duration of up to 15 minutes to assess psychological and physical complaints. Doctors will provide advice in this session.
The control group will receive TAU only.
For both groups, psychological and clinical parameters will be assessed at the baseline, at the end of the treatment, and 1, 3 and 6 months post-treatment.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

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 outcome measures

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, assessed by the total numbers of participants lost to follow-up compared to the number of participants recruited

Overall trial start date

01/06/2018

Overall trial end date

31/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

150 participants in the intervention group and 150 participants in the control group

Participant 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

Recruitment start date

01/01/2019

Recruitment end date

31/01/2019

Locations

Countries of recruitment

Malaysia

Trial participating centre

Thalassemia Daycare Centre of Hospital Serdang
Hospital Serdang Jalan Puchong of Kajang
Selangor
43000
Malaysia

Trial participating centre

Thalassemia Daycare Centre of Hospital Ampang
Hospital Ampang Jalan Mewah Utara Pandan Indah
Selangor
68000
Malaysia

Trial participating centre

Thalassemia Daycare Centre of Hospital Selayang
Hospital Selayang Lebuh Raya Lebuhraya Selayang - Kepong Batu Caves
Selangor
68100
Malaysia

Trial participating centre

Thalassemia Daycare Centre of Hospital Tengku Ampuan Rahimah
Hospital Tengku Ampuan Rahimah Jalan Langat Klang
Selangor
41200
Malaysia

Sponsor information

Organisation

Universiti Putra Malaysia

Sponsor details

Department of Family Medicine
Faculty of Medicine and Health Sciences
Universiti Putra Malaysia
serdang,selangor
43400
Malaysia

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Fakulti Perubatan dan Sains Kesihatan, Universiti Putra Malaysia

Alternative name(s)

Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, FPSK, UPM

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Malaysia

Results and Publications

Publication and dissemination plan

1. Trial protocol - intention to publish after receiving approval from the Ministry of Health’s Medical Research Ethics Committee and UPM’s Medical Research Ethics Committee and received approval of trial registration
2. Systematic literature reviews and meta-analysis of psychological intervention for anxiety and depression in thalassemia
3. Publication of the complete trial results after completion of the study

IPD sharing statement:
The datasets generated during and/or analyzed during the current study will be/are available upon request from Dr. Dayangku Hayaty Awg Dzulkarnain (yatyadzul@gmail.com). The data will be dependently available (restricted to participant's consent and parents/legal guardian's consent for minor, approval from the Ministry of Health Ethics Committee, University Putra Malaysia Ethics Committee and the sponsor (Universiti Putra Malaysia)). The criteria for approval of data sharing needs to be consistent with the studied policy on sharing (for educational use, peer review journal, for the proposed research which is bona fide and methodologically sound). The data sharing agreement is issued and signed by the appropriate authorities upon release of the data. The data will be available for one month.

Intention to publish date

31/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/11/2018: Internal review.