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CTRI Number  CTRI/2025/02/080475 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Helping Tuberculosis patients accept their condition and follow treatment. 
Scientific Title of Study   Efficacy of Acceptance and Commitment Therapy on Illness Acceptance and Medication Adherence Among Patients With Multi-Drug Resistant Tuberculosis 
Trial Acronym  ACT-MDR-TB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swatantra kumar 
Designation  M.Phil. Clinical Psychology Trainee 
Affiliation  Amity University Uttar pradesh 
Address  Department of Clinical Psychology, Amity Institute of Behavioural and Allied Sciences (AIBAS), Amity University Lucknow Campus, Malhaur, Lucknow, Uttar Pradesh – 226028

Lucknow
UTTAR PRADESH
226028
India 
Phone  09565374151  
Fax    
Email  gaurav.swatantra177@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Syed Sajid Husain Kazmi 
Designation  Assistant Professor, Clinical Psychology 
Affiliation  Amity University Uttar pradesh 
Address  Department of Clinical Psychology, Amity Institute of Behavioural and Allied Sciences (AIBAS), Amity University, Lucknow Campus Malhaur, Lucknow, Uttar Pradesh – 226028, India
Amity University Uttar Pradesh
Lucknow
UTTAR PRADESH
226028
India 
Phone  8565001786  
Fax    
Email  sshkazmi@lko.amity.edu  
 
Details of Contact Person
Public Query  
Name  Dr. Syed Sajid Husain Kazmi 
Designation  Assistant Professor Clinical Psychology 
Affiliation  Amity University Uttar pradesh 
Address  Department of Clinical Psychology, Amity Institute of Behavioural and Allied Sciences (AIBAS), Amity University, Lucknow Campus Malhaur, Lucknow, Uttar Pradesh – 226028, India

Lucknow
UTTAR PRADESH
226028
India 
Phone  8565001786  
Fax    
Email  sshkazmi@lko.amity.edu  
 
Source of Monetary or Material Support  
Swatantra Kumar, Department of Clinical Psychology, Amity Institute of Behavioural and Allied Sciences (AIBAS), Amity University, Lucknow Campus, Malhaur, Lucknow, Uttar Pradesh – 226028, India 
 
Primary Sponsor  
Name  Swatantra Kumar 
Address  Department of Clinical Psychology, Amity Institute of Behavioural and Allied Sciences (AIBAS), Amity University, Lucknow Campus Malhaur, Lucknow, Uttar Pradesh – 226028, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Syed Sajid Husain Kazmi  combined TB Hospital Lucknow  Directly Observed Therapy Tondan Marg (DOTS) Room, Thakurganj, Basant Vihar Colony, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH 		 8565001786

sshkazmi@lko.amity.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AMITY UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Acceptance and Commitment Therapy (ACT)  ACT is a form of psychotherapy that uses mindfulness and behavioral strategies to increase psychological flexibility. It will be delivered over 8 sessions (1 session per week), focusing on improving illness acceptance, medication adherence in MDR-TB patients 
Comparator Agent  Treatment as Usual (TAU)  Participants in this group will continue to receive standard anti-tuberculosis treatment (DOTS or alternative regimen) with no additional psychological intervention. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  The study will include multi-drug resistant tuberculosis (MDR-TB) patients aged 18 to 45 years who provide written informed consent for participation in either the Acceptance and Commitment Therapy (ACT) group or the Treatment as Usual (TAU) group. Eligible participants must have a confirmed diagnosis of MDR-TB through sputum microscopy and culture and should be within 6 to 9 months of diagnosis, actively undergoing standard anti-tuberculosis treatment (such as DOTS or an alternative regimen) in an outpatient setting. Additionally, participants must have basic Hindi or English reading and writing skills to comprehend the intervention materials effectively. 
 
ExclusionCriteria 
Details  The study will exclude MDR-TB patients who do not provide written informed consent for either the ACT or TAU group. Patients with cognitive impairments, a history or current diagnosis of psychiatric or major medical illnesses, or those undergoing psychiatric or psychological interventions during the study will not be included. Additionally, individuals with drug or substance dependence that may hinder participation in the intervention process will be excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Illness Acceptance (measured using Acceptance of illness scale at Baseline (Week 0), Post-Intervention (Week 8)  Illness Acceptance (measured using Acceptance of illness scale at Baseline (Week 0), Post-Intervention (Week 8) 
 
Secondary Outcome  
Outcome  TimePoints 
Illness Acceptance (measured using Acceptance of illness scale at Baseline (Week 0), Post-Intervention (Week 8)  Illness Acceptance (measured using Acceptance of illness scale at Baseline (Week 0), Post-Intervention (Week 8) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   27/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

This study aims to evaluate the efficacy of Acceptance and Commitment Therapy (ACT) in improving illness acceptance and medication adherence among patients with multi-drug-resistant tuberculosis (MDR-TB). The study will involve patients aged 18-45 years, diagnosed with MDR-TB within the last 6-9 months, and undergoing standard anti-tuberculosis treatment. Participants will be randomly assigned to either the ACT intervention group or the treatment-as-usual group. The study will assess primary outcomes, including illness acceptance and medication adherence, at multiple time points: baseline, post-intervention (8 weeks), and follow-ups at 3 and 6 months.


 
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