The effect of counseling based on cognitive-behavioral therapy on anxiety thoughts of pregnant women with history of fetal abnormality
Design
A double-blind, randomized clinical trial with intervention and control groups. The method of assigning the intervention to people is randomly and by the method of randomized permutation blocks with a block size of 4 with an assignment ratio of 1 to 1.
Settings and conduct
The intervention in this study starts from the age of 18 to 20 weeks of pregnancy and the end of the intervention is the counseling session after 8 weeks. The place is in health centers. It will be the control and after that the intervention group will receive cognitive-behavioral therapy in the form of 8 sessions once a week
Participants/Inclusion and exclusion criteria
1. Entry requirements of minimum elementary education
2. Age 18 to 40 years
3. Pregnancy age 18 to 20 weeks
4. History of fetal abnormality in previous pregnancy
5. Getting a score one standard deviation higher than the average in the Wells Anxiety Thoughts Questionnaire
Exclusion conditions 1. Suffering from chronic diseases
2. Suffering from mental illnesses during the last year and taking psychoactive drugs
4. Occurrence of pregnancy complications
6. Participation in counseling sessions during the study or three months before the study
7. Facing stressful events such as separation crisis or death of first degree relatives
Intervention groups
The questionnaire will be completed upon entering the study as a pre-test for both the intervention and control groups, and after that the intervention group will receive cognitive-behavioral therapy in the form of 8 sessions once a week.
Main outcome variables
Anxious thoughts
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230726058936N1
Registration date:2023-08-29, 1402/06/07
Registration timing:registered_while_recruiting
Last update:2023-08-29, 1402/06/07
Update count:0
Registration date
2023-08-29, 1402/06/07
Registrant information
Name
Zeinab Davoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4365 1444
Email address
jan_jani36@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-22, 1402/05/31
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling based on cognitive behavioral therapy on anxiety thoughts of pregnant women with a history of fetal abnormalities
Public title
The Effect of Cognitive Behavioral Counseling on Anxiety Thoughts in Pregnant Women with a History of Fetal Abnormality
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1. Minimum primary education
2. Age 18 to 40 years
3. Gestational age 18 to 20 weeks
4. History of fetal abnormality in previous pregnancy
5. Score one standard deviation above the mean in Wells anxiety thoughts questionnaire
Exclusion criteria:
1. Chronic diseases such as heart disease, high blood pressure, diabetes
2. Mental illness in recent years and taking psychotropic drugs
3. Drug and Cigarette Addiction
4. Pregnancy complications such as preeclampsia, bleeding
5. Absence of more than two sessions in therapy sessions
6. Attending counseling sessions during the study or three months before the study
7. Dealing with stressful events such as separation crisis or death of first-degree relatives
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
. The method of assigning intervention to the subjects is randomized, using random permutation blocks with block size 4 (using the table related to random permutations) and with a ratio of 1:1. The randomization list is prepared by a statistical expert. Codes assigned to qualified individuals by an outside person who does not know the research objectives will be plThey will not know who is in the group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This way, the researcher and participants will be unaware of who is in what group until the study begins.
Placebo
Not used
Assignment
Other
Other design features
The questionnaire completed at the beginning of the study will be as a pretest of both intervention and control groups, and then the intervention group will receive cognitive-behavioral therapy in the form of 8 sessions of 90 minutes, once a week, and the control group will only receive routine prenatal care.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Davood Davoodi Alley, Takhti Sq., Emam Ave.
City
izeh
Province
Khouzestan
Postal code
6391753611
Approval date
2023-07-23, 1402/05/01
Ethics committee reference number
IR.AJUMS.REC.1402.253
Health conditions studied
1
Description of health condition studied
anxiety thoughts of pregnant women with a history of fetal abnormalities
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxious thoughts score in the Wells Anxiety Thoughts Questionnaire
Timepoint
Before the intervention began.At the beginning of the study (before the start of the intervention) and at the end of the intervention (8 weeks after the start of the intervention) and one month after the end of the intervention with Wells Anxiety Thought Questionnaire
Method of measurement
Wells Anxiety Thought Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention in this study starts from the age of 18 to 20 weeks of pregnancy (that is, after the results of fetal abnormality screening and ultrasound) and the end of the intervention is after 8 weeks of counseling session. The intervention group will receive cognitive-behavioral therapy in the form of 8 sessions of 90 minutes, once a week. Session plan: The first session: introducing the members to each other, the rules and structure of the group, explaining the purpose of the study to the participants, emphasizing Confidentiality of answers, treatment contract, description of how to complete the questionnaire, familiarization with the problem of anxiety thoughts caused by fetal abnormality, description of cognitive-behavioral therapy and the beginning of the second session training: cognitive skills training, review of the topics of the first session, relaxation training, skill training Imagination, presentation of the task of the third session: getting to know the negative thoughts and beliefs that cause negative feelings towards the current pregnancy with regard to the experience of abnormality in the previous pregnancy, reviewing the previous session and checking the completion of the task, describing different types of maladaptive cognitions, recognizing Inconsistent thoughts and self-talks, description of emotions associated with inconsistent cognition, presentation of the assignment of the fourth session: explanation of the effect of psychological factors on the outcome of the current pregnancy, review of the previous session and review of the assignment, training of psychological factors (founding factors, revealing factors, maintaining factors) ), presentation of the task of the fifth session: cognitive restructuring, review of the previous session and review of homework, cognitive restructuring and change of negative attitude towards the current pregnancy, presentation of the task of the sixth session: teaching to correct anxious thoughts, review of the previous session and review of homework, review Anxious thoughts and challenging their validity, presentation of the assignment of the seventh session: training to replace positive thoughts instead of anxious thoughts, review of the previous session and review of the assignment of the eighth session: training of communication skills and problem solving, overview, implementation of the post-test
Category
Other
2
Description
Control group: El cuestionario de información demográfica y el cuestionario de pensamientos de ansiedad serán aplicados a gestantes con antecedentes de anomalías fetales con edad gestacional de 18-20 semanas que remitan a centros de salud que reúnan las condiciones para ingresar al estudio, y el grupo control recibirá únicamente los cuidados habituales del embarazo.Tras finalizar el estudio, el grupo control recibirá el tratamiento basado en el asesoramiento cognitivo-conductual en forma de reunión presencial junto con un CD con el material enseñado al grupo intervención.