| CTRI Number |
CTRI/2015/07/005973 [Registered on: 06/07/2015] Trial Registered Retrospectively |
| Last Modified On: |
27/01/2020 |
| 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. |
| Trial Acronym |
|
|
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
|
|
|
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
|
|
|
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
|
|
|
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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study was 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).
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 was 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.
Results: The modified MBCT was reasonably accepted by
infertile couples. The total attrition was below 30%. Mean Compliance during
sessions was above 70%. At follow-up, the mean compliance was 53% in women and
33% in men. Factors associated with the take-up of therapy, compliance and
attrition were identified. There were no adverse effects from practice of MBCT.
In women, between-group differences obtained on ISS, Anxiety,
Depression, FertiQol and Coping were found to be statistically
significant.
In men between-group differences obtained on ISS, FertiQol and
Mindfulness coping were found to be statistically significant.
This study also provides a limited evidence for enhanced fertility
outcomes in MBCT group. Superior outcomes were also observed in couples who
underwent booster MBCT sessions and in those who conceived as well as continued
MBCT practice during their early gestational period.
|