Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06001021
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-21
First Post:
2023-06-26
Brief Title:
Cognitive Behavioral Couple Therapy for Perinatal Distress
Sponsor:
Sameera Shafiq
Organization:
University of Gujrat
Study Overview
Official Title:
The Effectiveness of Psychopharmacological Intervention Versus Cognitive Behavioural Couple Therapy and Their Combination in Perinatal Distressed Couples A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The hypotheses of the study are
There will be differences in perceived distress dyadic coping strategies social support quality of life and well-being in couples at Pre- and Post-Test Levels during the perinatal period in couples
There will be differences in psychopharmacology on total scores of perceived distress dyadic coping strategies social support quality of life and well-being between the experimental and wait list-placebo control groups
There will be differences in CBCT condition without Zikr on total scores of perceived distress dyadic coping strategies social support quality of life and well-being between the experimental and wait list control group
There will be differences in CBCT condition with Zikr on total scores of perceived distress dyadic coping strategies social support quality of life and well-being between the experimental and wait list-placebo control groups
There will be differences for combined psychopharmacology and CBT conditions with Zikr without Zikr dimensions on total scores of perceived distress dyadic coping strategies social support quality of life and well-being between experimental and wait list-placebo control group
There will be differences in perceived distress dyadic coping strategies social support quality of life and well-being in couples at Pre- and Post-Test Levels during the perinatal period in couples
There will be differences in psychopharmacology on total scores of perceived distress dyadic coping strategies social support quality of life and well-being between the experimental and wait list-placebo control groups
There will be differences in CBCT condition without Zikr on total scores of perceived distress dyadic coping strategies social support quality of life and well-being between the experimental and wait list control group
There will be differences in CBCT condition with Zikr on total scores of perceived distress dyadic coping strategies social support quality of life and well-being between the experimental and wait list-placebo control groups
There will be differences for combined psychopharmacology and CBT conditions with Zikr without Zikr dimensions on total scores of perceived distress dyadic coping strategies social support quality of life and well-being between experimental and wait list-placebo control group
Detailed Description:
The research questions of the study are
How effective will psychopharmacological treatment CBCT and combined medicine-CBCT interventions be in reducing symptoms of distress and improving quality of life among couples during the perinatal period through a randomized clinical trial
Will dyadic coping strategies social support quality of life and well-being be improved in couples at the post-test level as compared to the pre-test level by therapeutic intervention through a randomized clinical trial
What impact this above-stated different mode of intervention will have on perceived distress dyadic coping strategies social support quality of life and well-being between experimental and wait list-placebo control groups
Procedures and Protocol
The investigator will ask willing participants screened for high risk to select one of their preferred treatment modes out of the following
1 Medications antidepressants andor anxiolytics
2 Cognitive Behavioural Therapy without Zikr
3 Cognitive Behavioural Therapy with Zikr
4 Combination of medications and cognitive behavioral therapy
5 Combination of medications cognitive behavioral therapy and Zikr
A list of willing participants will be prepared Each participant will have one in five chances of getting the preferred treatment mode There will be two groups experimental and control To put people into one of the two groups the investigator will select by chance for instance by tossing a coin
Participants will not know to which group they actually belong This information will be recorded in the investigators files but the research assistant will not look at these files until after the research is finished This is the best way the investigators have for testing without being influenced by what they think or hope might happen The investigator and research assistant will then compare which of the two has the best results
The healthcare professionals consultant gynecologists and investigators research assistant will be looking after the participants very carefully during the study If there are anything participants are concerned about or that is bothering them about the research they will talk to the researcher research assistant gynaecologist or staff
A placebo or inactive medicine looks like real medicine but it is not It is a dummy or pretend medicine It has no effect on a person because it has no real medicine in it The investigator wants to know whether medicine is good therefore some people will be given the medicine and others will be given the pretend or a dummy medicine For the research to be good it is important that participants do not know whether they have been given real medicine or pretend or dummy medicine This is one of the best ways the investigator have for knowing what the medicine that are being tested really does But the participants given a placebo will be informed at the end of the study and will be given treatment with medication as they are wait-list control Participants will receive psychopharmacological treatment according to the National Institute for Health and Care Excellence NICE guidelines
Description of the Process
During the research a couple has to make ten visits to attend ten sessions in the hospital
In the first visit rapport will be built and pre-test assessment will be done in the following two approaches
Quantitative Approach
Indigenously developed Parental Perinatal Distress Scale PPDS
Multidimensional Scale for Perceived Social Support MSPSS
Dyadic Coping Inventory DCI
Flourishing Scale FS
World Health Organizations Quality of Life Brief WOLQOL-BREF
Qualitative Approach
In a qualitative approach the semi-structured interviews will be conducted to explore the present stressors and expectations and perceptions about the effectivity of treatments for perinatal distress among couples
Group 1 will be given medications or placebo for two weeks andor for four to five weeks maximum as per requirement by the consultant gynaecologist They have to visit after two weeks for post-test assessment After treatment the medicine will be tapered off to stop the intake As explained before neither participant will know whether they have received the medicine or the placebo But in the end placebo participants will be debriefed and will be continued with real medication
Group 2 Group 3 and Group 4 will continue the following 10 sessions two sessions each one hour per week of CBCT with the investigator
In the second session participants will be psycho-educated for perinatal period distress couples physical and mental health and impact on the fetus-infant the prevalence of depression and anxiety and the significance of identification Progressive muscle relaxation exercises will be carried out along with deep breathing Feedback on the session will be taken
In the third session participants will be psycho-educated on the theoretical model of cognitive-behavioral couple therapy with some historical highlights and empirical standing A thought log will be given for homework Feedback for deep breathing and progressive muscle relaxation will be carried out
In the fourth fifth sixth seventh eighth and ninth session feedback will be taken on homework and session Various techniques of Cognitive Behavioural Couple Therapy will be applied based on the nature and contents of identified precipitating perpetuating and present stressors In addition relevant techniques will be incorporated from other modalities with eclecticism Tasbeeh in Zikr will be given to group 3 and group 5 who opted for it in the screening process
On the tenth visit feedback on the session and homework will be taken post-test assessment will be done in the following two approaches Group 5 will be exposed to one of the two conditions 50 of couples will get a placebo and 50 will receive routine treatment care with no intervention However after the completion of the research this waitlist group control will be briefed and will be delivered with an intervention mode of treatment of their choice as selected earlier
Quantitative Approach Indigenously developed Parental Perinatal Distress Scale PPDS Multidimensional Scale for Perceived Social Support MSPSS Dyadic Coping Inventory DCI
Flourishing Scale FS
World Health Organizations Quality of Life Brief WOLQOL-BREF Qualitative Approach
In a qualitative approach the semi-structured interview will be conducted to explore the present stressors and expectations and perceptions about effectivity of treatments for perinatal distress among couples
Duration The research takes place from 15th August 2023 to 30th September 2023 Screening for Major Depressive Disorder Generalized Anxiety Disorder with PPDS will be carried out on the couples who visit the gynecological ward of the hospital in August After screening and signed informed consent it will be necessary for participants to come to the clinichospital for 10 days in total for one hour each day in September two sessions per week each for one hour
The investigator and the research assistant would like to meet with participants twice in the upcoming month after the participants last session visit for a final check-up in follow-ups
How effective will psychopharmacological treatment CBCT and combined medicine-CBCT interventions be in reducing symptoms of distress and improving quality of life among couples during the perinatal period through a randomized clinical trial
Will dyadic coping strategies social support quality of life and well-being be improved in couples at the post-test level as compared to the pre-test level by therapeutic intervention through a randomized clinical trial
What impact this above-stated different mode of intervention will have on perceived distress dyadic coping strategies social support quality of life and well-being between experimental and wait list-placebo control groups
Procedures and Protocol
The investigator will ask willing participants screened for high risk to select one of their preferred treatment modes out of the following
1 Medications antidepressants andor anxiolytics
2 Cognitive Behavioural Therapy without Zikr
3 Cognitive Behavioural Therapy with Zikr
4 Combination of medications and cognitive behavioral therapy
5 Combination of medications cognitive behavioral therapy and Zikr
A list of willing participants will be prepared Each participant will have one in five chances of getting the preferred treatment mode There will be two groups experimental and control To put people into one of the two groups the investigator will select by chance for instance by tossing a coin
Participants will not know to which group they actually belong This information will be recorded in the investigators files but the research assistant will not look at these files until after the research is finished This is the best way the investigators have for testing without being influenced by what they think or hope might happen The investigator and research assistant will then compare which of the two has the best results
The healthcare professionals consultant gynecologists and investigators research assistant will be looking after the participants very carefully during the study If there are anything participants are concerned about or that is bothering them about the research they will talk to the researcher research assistant gynaecologist or staff
A placebo or inactive medicine looks like real medicine but it is not It is a dummy or pretend medicine It has no effect on a person because it has no real medicine in it The investigator wants to know whether medicine is good therefore some people will be given the medicine and others will be given the pretend or a dummy medicine For the research to be good it is important that participants do not know whether they have been given real medicine or pretend or dummy medicine This is one of the best ways the investigator have for knowing what the medicine that are being tested really does But the participants given a placebo will be informed at the end of the study and will be given treatment with medication as they are wait-list control Participants will receive psychopharmacological treatment according to the National Institute for Health and Care Excellence NICE guidelines
Description of the Process
During the research a couple has to make ten visits to attend ten sessions in the hospital
In the first visit rapport will be built and pre-test assessment will be done in the following two approaches
Quantitative Approach
Indigenously developed Parental Perinatal Distress Scale PPDS
Multidimensional Scale for Perceived Social Support MSPSS
Dyadic Coping Inventory DCI
Flourishing Scale FS
World Health Organizations Quality of Life Brief WOLQOL-BREF
Qualitative Approach
In a qualitative approach the semi-structured interviews will be conducted to explore the present stressors and expectations and perceptions about the effectivity of treatments for perinatal distress among couples
Group 1 will be given medications or placebo for two weeks andor for four to five weeks maximum as per requirement by the consultant gynaecologist They have to visit after two weeks for post-test assessment After treatment the medicine will be tapered off to stop the intake As explained before neither participant will know whether they have received the medicine or the placebo But in the end placebo participants will be debriefed and will be continued with real medication
Group 2 Group 3 and Group 4 will continue the following 10 sessions two sessions each one hour per week of CBCT with the investigator
In the second session participants will be psycho-educated for perinatal period distress couples physical and mental health and impact on the fetus-infant the prevalence of depression and anxiety and the significance of identification Progressive muscle relaxation exercises will be carried out along with deep breathing Feedback on the session will be taken
In the third session participants will be psycho-educated on the theoretical model of cognitive-behavioral couple therapy with some historical highlights and empirical standing A thought log will be given for homework Feedback for deep breathing and progressive muscle relaxation will be carried out
In the fourth fifth sixth seventh eighth and ninth session feedback will be taken on homework and session Various techniques of Cognitive Behavioural Couple Therapy will be applied based on the nature and contents of identified precipitating perpetuating and present stressors In addition relevant techniques will be incorporated from other modalities with eclecticism Tasbeeh in Zikr will be given to group 3 and group 5 who opted for it in the screening process
On the tenth visit feedback on the session and homework will be taken post-test assessment will be done in the following two approaches Group 5 will be exposed to one of the two conditions 50 of couples will get a placebo and 50 will receive routine treatment care with no intervention However after the completion of the research this waitlist group control will be briefed and will be delivered with an intervention mode of treatment of their choice as selected earlier
Quantitative Approach Indigenously developed Parental Perinatal Distress Scale PPDS Multidimensional Scale for Perceived Social Support MSPSS Dyadic Coping Inventory DCI
Flourishing Scale FS
World Health Organizations Quality of Life Brief WOLQOL-BREF Qualitative Approach
In a qualitative approach the semi-structured interview will be conducted to explore the present stressors and expectations and perceptions about effectivity of treatments for perinatal distress among couples
Duration The research takes place from 15th August 2023 to 30th September 2023 Screening for Major Depressive Disorder Generalized Anxiety Disorder with PPDS will be carried out on the couples who visit the gynecological ward of the hospital in August After screening and signed informed consent it will be necessary for participants to come to the clinichospital for 10 days in total for one hour each day in September two sessions per week each for one hour
The investigator and the research assistant would like to meet with participants twice in the upcoming month after the participants last session visit for a final check-up in follow-ups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None