Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202412822674360 Date of Registration: 24/12/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Relaxation Technology Cognitive Behavioral Therapy on Depression, Anxiety, Quality of Life, and Treatment Adherence among Pulmonary Tuberculosis Patients in Ethiopia: a Randomized Control Trial
Official scientific title Effect of Relaxation Technology Cognitive Behavioral Therapy on Depression, Anxiety, Quality of Life, and Treatment Adherence among Pulmonary Tuberculosis Patients in Ethiopia.
Brief summary describing the background and objectives of the trial Despite the fact that the effect of Cognitive Behavioral Therapy (CBT) interventional study has done on the anxiety, depression, among patients with other chronic diseases, and most of the studies were done separately on either the effect of CBT or the effect of RT on anxiety and depression among tuberculosis patients, as far as my knowledge is concerned, no study has been conducted on the effect of RT-CBT on anxiety, depression, quality of life, and treatment adherence of pulmonary tuberculosis patients, especially in the study area. So the objective of this study is to investigate the effect of RT-CBT intervention on depression, anxiety, quality of life, and treatment adherence of tuberculosis patients in Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RT-CBT
Disease(s) or condition(s) being studied Infections and Infestations,Mental and Behavioural Disorders,Respiratory
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Cognitive and Behavioral Intervention
Anticipated trial start date 01/02/2025
Actual trial start date 01/05/2025
Anticipated date of last follow up 30/09/2025
Actual Last follow-up date 28/02/2026
Anticipated target sample size (number of participants) 158
Actual target sample size (number of participants) 126
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Relaxation Technology Cognitive Behavioral Therapy Not applicable One year Relaxation Technology (RT) Cognitive Behavioral Therapy (RT-CBT) intervention is an integrated strategy for addressing mental health issues that combines CBT concepts with technology-driven relaxation technique practices. RT-CBT intervention is the integrating of technology-aided relaxation technique practice with the CBT structure framework. This combined intervention technique addresses both physiological and cognitive components of mental health issues, including anxiety, depression, and illnesses related to stress. 63
Control Group usual care One year Providing usual treatment, providing emotional support, Health education about the nature of the disease, education about nutrition, treatment adherence, etc. 63 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Patients who are newly diagnosed with pulmonary TB and currently on treatment for at least two weeks.  Patients aged 18 years or older  Patients who are previously diagnosed with pulmonary TB and required at least 4 months for treatment follow-up  Patient’s available in the area for at least 4 months  Participants had to be able to read and comprehend the local Tigrigna language.  Patients with known defects of sight, hearing, and speech  Patients with serious and critical illness  Patients who are currently receiving any psychological treatments or psychological therapy.  Patients with known psychiatric disorders and linked to psychiatric clinics. 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 10/12/2024 Zhengzhou University Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Henan Province, China Zhengzhou City 450001 China
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 13/12/2024 Mekelle University College of Health Science Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Mekelle City, Ayder 03, Tigray Province, Ethiopia Mekelle 1871 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Depression status At baseline Pre-intervention , during intervention at 8th weeks and at 3 months post intervention.
Secondary Outcome Anxiety, Quality of Life, and Treatment Adherence At baseline Pre-intervention , during intervention at 8th weeks and at 3 months post intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tigray region Northern Ethiopia Public Hospitals. Mekelle City, Ayder 03, Tigray Province, Ethiopia Mekelle 1871 Ethiopia
Zhengzhou University School of Nursing and Health Zhengzhou City, Henan province, China Zhengzhou 450001 China
FUNDING SOURCES
Name of source Street address City Postal code Country
Zhengzhou University Henan Province, China Zhengzhou City 450001 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Zhengzhou University Henan Province, China Zhengzhou City 450001 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gebrhud Berihu Haile gebrhud.berihu@mu.edu.et +8616638142904 Zhengzhou city, Henan Province, China
City Postal code Country Position/Affiliation
Zhengzhou City 450001 China Zhengzhou University and Mekelle University
Role Name Email Phone Street address
Scientific Enquiries Wang Peng upliz@zzu.edu.cn +8613653815021 Henan Province, China
City Postal code Country Position/Affiliation
Zhengzhou City 450001 China Zhengzhou University
Role Name Email Phone Street address
Public Enquiries Kalam Abul kalamazad00@gmail.com +8616638141015 Henan Province, China
City Postal code Country Position/Affiliation
Zhengzhou City 450001 China Zhengzhou University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participants data collected during the trial, after deidentification, will be shared. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan Immediately following the publication. No end date. Anyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 19/12/2024 Previously forgot to include the baseline and during intervention assessment and , but now updated based on the reviewer comments Primary Outcome, Depression status, 3 months Primary Outcome, Depression status, At baseline Pre-intervention , during intervention at 8th weeks and at 3 months post intervention.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 19/12/2024 Previously forgot to include the baseline and during intervention assessment and , but now updated based on the reviewer comments. Secondary Outcome, Anxiety, Quality of Life, and Treatment Adherence , 3 months Secondary Outcome, Anxiety, Quality of Life, and Treatment Adherence , At baseline Pre-intervention , during intervention at 8th weeks and at 3 months post intervention.