Investigating the effectiveness of compassion-focused therapy on psychological symptoms of women with recurrent spontaneous abortion
Design
A randomized controlled group with parallel-group, unblinded, on 52 patients. The online Randomly assign tool was used for randomization.
Settings and conduct
Clinical trial with repeated measures, parallel-group, single-blinded, randomized on 52 patients, random list generator app used for randomization
Participants/Inclusion and exclusion criteria
Age above 18؛ History of recurrent spontaneous abortion (having at least 2 miscarriages)؛ Not participating in psychological interventions during the last year؛ In case of taking psychiatric drugs, no change in the drugs during the last 6 months.
Intervention groups
In group one participants will undergo ten 60-minute psychotherapy sessions utilizing a compassion-focused treatment approach. The group two will consist of participants on a waiting list, who will not receive any intervention until the end of the first group's sessions.
Effectiveness of compassion-focused therapy on psychological symptoms of women with recurrent spontaneous abortion
Public title
compassion-focused therapy for women with recurrent spontaneous abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age above 18
History of recurrent spontaneous abortion (having at least 2 miscarriages)
Exclusion criteria:
participating in psychological interventions during the last year
In case of taking psychiatric drugs, change in the drugs during the last 6 months
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
All the people who entered the study were given a code, then these codes were entered into the Randomly assign online software (https://www.graphpad.com/quickcalcs/randomize1.cfm) and the software randomly assigned each code to a group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Shahid Beheshti University of Medical Science
Street address
Bldg No.2 Shahid Beheshti University of Medical science, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2023-08-29, 1402/06/07
Ethics committee reference number
IR.SBMU.MSP.REC.1402.288
Health conditions studied
1
Description of health condition studied
recurrent pregnancy loss
ICD-10 code
N96
ICD-10 code description
Recurrent pregnancy loss
Primary outcomes
1
Description
Depression score
Timepoint
before treatment, after the treatment, and 6 month after treatment
Method of measurement
Beck depression inventory
2
Description
Anxiety score
Timepoint
before treatment, after the treatment, and 6 month after treatment
Method of measurement
Beck anxiety inventory
3
Description
Resilience score
Timepoint
before treatment, after the treatment, and 6 month after treatment
Method of measurement
Connor-Davidson Resilience Scale
4
Description
Body image concern score
Timepoint
before treatment, after the treatment, and 6 month after treatment
Method of measurement
The Body Image Concern Inventory
5
Description
Internalized shame score
Timepoint
before treatment, after the treatment, and 6 month after treatment
Method of measurement
Internalized Shame Scale
6
Description
Perinatal grief score
Timepoint
before treatment, after the treatment, and 6 month after treatment
Method of measurement
Perinatal Grief Scale
Secondary outcomes
empty
Intervention groups
1
Description
This group underwent ten 60-minute weekly sessions of compassion-focused psychotherapy, aimed at developing a positive therapeutic relationship that facilitates the process of engaging with one's challenges and development of skills to deal with them, developing non-blaming compassionate understandings into the nature of suffering, developing the ability to experience and cultivate compassionate attributes and developing the feeling of compassion for others, being open to compassion from others, and developing self-compassion.
Category
Treatment - Other
2
Description
Control group: This was a waiting list, and clients in this group did not receive any therapy until the end of the therapy of the intervention group.