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CTRI Number  CTRI/2015/07/005973 [Registered on: 06/07/2015] Trial Registered Retrospectively
Last Modified On: 30/09/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The study is a a clinical trial to study the effectiveness of psychotherapy in reducing emotional distress in infertility couples, while they undergo infertility treatment (IUI) and face unsuccessful outcomes in such treatment cycles. 
Scientific Title of Study
Modification(s)  
Effectiveness of modified mindfulness based cognitive therapy in distressed couples with infertility, undergoing intra-uterine insemination.  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Ms Ansha Patel 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Manipal 
Address  Ms. Ansha Patel Department of Psychiatry Kasturba Medical College, Manipal university Manipal-576104

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  ansha_patel@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr PSVN Sharma 
Designation  HOD & Professor, Guide in this study 
Affiliation  Dept of Psychiatry, Kasturba Medical College, Manipal. 
Address  Room no. 33 Old OPD building, 3rd Floor, Department of Psychiatry Kasturba Medical College, Manipal university Manipal-576104

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  psvn.sharma@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Ms Ansha Patel 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Manipal 
Address  Ms. Ansha Patel Department of Psychiatry Kasturba Medical College, Manipal university Manipal-576104

Udupi
KARNATAKA
576104
India 
Phone  9742442438  
Fax    
Email  ansha_patel@yahoo.co.in  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Selfsponsored 
Address  Department of Psychiatry Self sponsored Ms. Ansha Patel Kasturba Medical College, Manipal university Manipal 
Type of Sponsor  Other [self sponsored] 
 
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 
Dr Pratap Kumar Professor and Head Division of reproductive medicine Dept of OBG  DEPT OF OBSTETRICS AND GYNAECOLOGY, DIVISION OF REPRODUCTIVE MEDICINE,MARC  DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, DIVISION OF REPRODUCTIVE MEDICINE, MANIPAL ASSISTED REPRODUCTION CENTRE, KASTURBA MEDICAL COLLEGE (KMC), MANIPAL UNIVERSITY MANIPAL
Udupi
KARNATAKA 
08202922162

pratap.kumar@manipal.edu 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Doctoral Accreditation Committee  Approved 
Kasturba Medical College, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Primary Infertility,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INTERVENTION TYPE: Behavioural Intervention, namely PSYCHOTHERAPY TYPE OF PSYCHOTHERAPY IN THIS STUDY: Mindfulness based cognitive therapy (MBCT) MODIFIED MBCT SESSION CONTENT , FREQUENCY, DURATION &FORMAT : The experimental group in this study consists of infertility couples , in which both wife and husband receive 6-DAILY-1.5HOUR-SESSIONS OF MBCT, in couple format, along with IUI (Treatment-as-usual at MARC)   CONCEPTUAL DEFINITION OF PSYCHOTHERAPY: Psychotherapy is a form of psychological intervention modality offered by mental health clinicians, for patients with significant emotional morbidity. PSYCHOTHERPAY is defined as a ‘treatment by psychological means of problems of emotional nature, in which a trained person, deliberately establishes a professional relationship with the patient with the object of (1) Removing, modifying, or retarding existing symptoms, (2) Mediating disturbed patterns of behavior, and (3) Promoting positive personality growth and development.’ BRIEF DESCRIPTION OF MBCT IN THIS STUDY: Mindfulness Based Cognitive Therapy is a multi-component evidence based psychotherapy that involves “training the mind in observing, describing, accepting whatever one is experiencing at present-moment, with the attitudinal qualities of acceptance, fearlessness, enlightment, courage, truth and compassion “. MODIFIED MBCT SESSION CONTENT : Prescribes several MBCT based cognitive-behavioural-emotional self-regulatory skills to help patients deal and cope with painful aspects of infertility. It aims to create a mindful acceptance of their life situations, self and relations. THE MODIFIED MBCT SESSION STRUCTURE : With permission from original authorities, in this study, the original format of MBCT has been altered and dovetailed to fit within the schedule of the routine assisted reproductive treatments and procedures offered at MARC.  
Comparator Agent  THE WAILISTED CONTROL GROUP: Does not receive any psychological intervention. They receive the routine IUI treatment at MARC.  The routine IUI treatment at MARC- Treatment-as-usual consists of detailed infertility evaluation, medical and lab investigations, for both wife & the husband. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Inclusion Criteria

• Persons who give consent for the study, with female partner of couple of Age 20 years to 35 years , Educated at least up to 10th standard and should be able to read and write Kannada.
• Couples who are coming as new cases to MARC , with p/h/o diagnosis of primary infertility
• Patients who have 5-10 years of p/h/o undergoing Assisted Reproductive Treatments
• Couples with PCOD in female partner and /or oligospermia and varicocele in male partner
• Suitable for intra-uterine insemination
• Neither partner of the couple meets any diagnostic criteria on Mini International Neuropsychiatric Interview ( English version 5.0).
• Having a significant infertility specific stress score , in either partner of the couple ,( i.e. raw score of 167 or above as assessed in females and of 147 or above as assessed in males) as measured on Fertility Problem Inventory.
 
 
ExclusionCriteria 
Details  • Couples with >10 years of diagnosis of primary infertility and p/h/o undergoing Assisted Reproductive Treatments.
• Couples who have undergone surgery in the last 3 months .
• Couples who are going to under surgeries in the coming 3 months
• Couples suitable for IVF
• Couples suitable for donor egg/ donor insemination
• Couples in which female partner has a diagnosis of recent cyst/ fibroids/ endometrioses and /or males with a diagnosis of azoospermia/aspermia.
• Couples in which either partner with diagnosed with any psychiatric disorder or on Rx for psychiatric comorbidities ,or meets the diagnostic criteria on Mini International Neuropsychiatric Interview ( English version 5.0).
• Having an insignificant infertility specific stress score in both the partner of the couple ( raw score of or less than 167 as assessed in females and equal/less than 147 as assessed in males) as measured on Fertility Problem Inventory.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Infertility Specific Stress assessed by Fertility Problem Inventory  Pre to Post Intervention, 1 month 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
ii. Mindfulness skills : Assessed by Kentucky Inventory for Mindfulness Skills
 
Pre to Post intervention, 1 months 
iii. Anxiety and Depression: Assessed by Hamilton anxiety and depression scale.  Pre to Post Intervention, 1 month 
v. Fertility related Quality of life : Assessed by Ferti QOL
 
Pre to post intervention, 1 month 
 
Target Sample Size
Modification(s)  
Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="192" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   30/05/2014 
Date of Study Completion (India) 02/02/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Brief Summary  

This study is a randomized controlled single centre trail, with a 2 group design,  to test the effectiveness of  modified Mindfulness Based Cognitive Therapy  for  distressed couples with infertility undergoing unsuccessful outcomes on Intra Uterine Insemination (Experimental group) , in  comparison to those distressed couples with infertility undergoing unsuccessful outcomes on Intra Uterine Insemination, who are in treatment as usual  (The waitlisted control group), and assess change in scores on Infertility-Specific Stress and study variables (Mindfulness, Anxiety, Depression, Marital Distress and Fertility related Qol), from pre to post-intervention stage. The primary outcome is the change in scores on mean infertility specific stress experienced by each of the partners in the couple, after 2 months (from pre-post intervention), among the two study groups. The secondary outcome would be changes in scores on mean mindfulness skills, symptoms of depression, symptoms of anxiety, marital distress and Fertility related quality of life in the couples after 2 months (from pre-post intervention),  among the two study groups.

 

 

 
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