Depression, PostpartumNCT06431672
Perinatal Interpersonal Psychotherapy Group for Distressed Women
A study testing interpersonal group psychotherapy in people with Depression, Postpartum and Social Adjustment, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
This is the first perinatal interpersonal psychotherapy group (P-IPTG) implemented for distressed women from pregnancy to postpartum. The feasibility and effects of P-IPTG are explored. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Postpartum, Social Adjustment
- What is being tested?
- interpersonal group psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women in the third trimester of pregnancy, at least 20 years old, able to read and write in Chinese, and "depressed, anxious, or wishing to improve family relationships."
Who cannot join
- women with schizophrenia, substance use, or suicide risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility and Effects of Perinatal Interpersonal Psychotherapy Group for Distressed Women
This is the first perinatal interpersonal psychotherapy group (P-IPTG) implemented for distressed women from pregnancy to postpartum. The feasibility and effects of P-IPTG are explored.
Read the detailed description
This is the first perinatal interpersonal psychotherapy group (P-IPTG) implemented for distressed women from pregnancy to postpartum. The feasibility and effects of P-IPTG are explored. The third-trimester women were recruited as intervention and control group participants by a quasi-experimental design.
- Conditions
- Depression, Postpartum, Social Adjustment
- Being tested
- interpersonal group psychotherapy
- Keywords
- feasibility, group psychotherapy, interpersonal psychotherapy, maternal depression, perinatal adjustment
- Medical subject headings
- Depression, Postpartum, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interpersonal group psychotherapyOther
Interpersonal psychotherapy (IPT) was developed by Stuart and O'Hara (1995). It addresses four domains of conflict. The intervention is an eight-session P-IPTG, which consisted of four sessions in pregnancy and four in postpartum.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The intervention was an eight-session P-IPTG, which consisted of four sessions in pregnancy and four in postpartum. All participants replied to the measures at four waves from baseline to one year postpartum. The outcome variables were within-group and between-group changes in depression, social support, dyadic adjustment, interpersonal relationship satisfaction, and mother-infant bonding. Receives: Other: interpersonal group psychotherapy |
| control group | No intervention | The participants of control group reply questionnaires for four times. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale (EPDS, Cox et al., 1987) was used to assess depressive symptoms. It consists of ten Likert-type items with 0 to 3 points, with higher scores indicating more depressive symptoms over the past week. Following the previous study (Su et al., 2007), we used higher than 12 to define participants with significant depressive tendencies.
Measured: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
Dyadic Adjustment Scale
The Dyadic Adjustment Scale (DAS, Spanier, 1976) assessed women's perceived quality of either married or unmarried couple relationship. The scale consists of 32 items, primarily scored in a 6-point scale (27 items). It measures four factors: dyadic consensus, dyadic satisfaction, dyadic cohesion, and affectionate expression. Higher scores indicate better dyadic adjustment in respective aspects.
Measured: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
Social Network Interaction System Questionnaire (SNISQ, Lay & Liu, 1996)
The Social Network Interaction System Questionnaire (SNISQ, Lay \& Liu, 1996) was used to evaluate perceptions of social support from partners, original families, and in-laws. The SNISQ consists of nine Likert-type items with 1 to 4 points, with higher scores indicating better- perceived support from specific individuals.
Measured: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
Satisfaction with Interpersonal Relationships Scale (Chan et al., 2002)
Chan et al. (2002) used the Satisfaction with Interpersonal Relationships Scale (SWIRS,) to assess women's satisfaction with their relationships with partners and mothers-in-law over the past few weeks. We expanded the scale to include ratings of relationships with fathers, mothers, and fathers-in-law, resulting in five items. The SWIRS is a Likert-type item with 1 to 7 points, with higher scores indicating greater satisfaction with the relationship.
Measured: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
Mother-Infant Bonding Inventory (Shieh et al., 2015)
The Mother-Infant Bonding Inventory (MIBI, Shieh et al., 2015) assessed mothers' thoughts, feelings, and commitment toward their infants. The MIBI consists of 25 items scored on 1 to 6 points. Its four factors are proximity, parental adjustment, commitment, and confidence of reciprocity. Higher scores indicate good mother-infant bonding in specific aspects.
Measured: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start15 Mar 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peyling Shieh, Chung Shan Medical University
- Investigators
- Peyling Shieh, Ph. D., Principal investigator, Chung Shan Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431672
- Sponsor's protocol ID
- MOST 106-2410-H-040-004 -SSS
- Other IDs
- MOST 107-2410-H-040-005 -SSS
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For confidentiality, we plan to share IPD with other researchers by contact.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Effects of Perinatal Interpersonal Psychotherapy Group for Distressed Women
- ClinicalTrials.gov ID
- NCT06431672
- Acronym / sponsor ID
- MOST 106-2410-H-040-004 -SSS
- Conditions
- Depression, Postpartum, Social Adjustment
- Keywords
- feasibility, group psychotherapy, interpersonal psychotherapy, maternal depression, perinatal adjustment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is the first perinatal interpersonal psychotherapy group (P-IPTG) implemented for distressed women from pregnancy to postpartum. The feasibility and effects of P-IPTG are explored.
Detailed description
This is the first perinatal interpersonal psychotherapy group (P-IPTG) implemented for distressed women from pregnancy to postpartum. The feasibility and effects of P-IPTG are explored. The third-trimester women were recruited as intervention and control group participants by a quasi-experimental design.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: interpersonal group psychotherapyThe intervention was an eight-session P-IPTG, which consisted of four sessions in pregnancy and four in postpartum. All participants replied to the measures at four waves from baseline to one year postpartum. The outcome variables were within-group and between-group changes in depression, social support, dyadic adjustment, interpersonal relationship satisfaction, and mother-infant bonding. |
| control group | No intervention | –The participants of control group reply questionnaires for four times. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women in the third trimester of pregnancy, at least 20 years old, able to read and write in Chinese, and "depressed, anxious, or wishing to improve family relationships."
Key exclusion criteria (1 listed)
- women with schizophrenia, substance use, or suicide risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interpersonal group psychotherapyInterpersonal psychotherapy (IPT) was developed by Stuart and O'Hara (1995). It addresses four domains of conflict. The intervention is an eight-session P-IPTG, which consisted of four sessions in pregnancy and four in postpartum. | Other | intervention group |
Primary outcome
Edinburgh Postnatal Depression Scale
Time frame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
The Edinburgh Postnatal Depression Scale (EPDS, Cox et al., 1987) was used to assess depressive symptoms. It consists of ten Likert-type items with 0 to 3 points, with higher scores indicating more depressive symptoms over the past week. Following the previous study (Su et al., 2007), we used higher than 12 to define participants with significant depressive tendencies.
Dyadic Adjustment Scale
Time frame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
The Dyadic Adjustment Scale (DAS, Spanier, 1976) assessed women's perceived quality of either married or unmarried couple relationship. The scale consists of 32 items, primarily scored in a 6-point scale (27 items). It measures four factors: dyadic consensus, dyadic satisfaction, dyadic cohesion, and affectionate expression. Higher scores indicate better dyadic adjustment in respective aspects.
Social Network Interaction System Questionnaire (SNISQ, Lay & Liu, 1996)
Time frame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
The Social Network Interaction System Questionnaire (SNISQ, Lay \& Liu, 1996) was used to evaluate perceptions of social support from partners, original families, and in-laws. The SNISQ consists of nine Likert-type items with 1 to 4 points, with higher scores indicating better- perceived support from specific individuals.
Satisfaction with Interpersonal Relationships Scale (Chan et al., 2002)
Time frame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
Chan et al. (2002) used the Satisfaction with Interpersonal Relationships Scale (SWIRS,) to assess women's satisfaction with their relationships with partners and mothers-in-law over the past few weeks. We expanded the scale to include ratings of relationships with fathers, mothers, and fathers-in-law, resulting in five items. The SWIRS is a Likert-type item with 1 to 7 points, with higher scores indicating greater satisfaction with the relationship.
Mother-Infant Bonding Inventory (Shieh et al., 2015)
Time frame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
The Mother-Infant Bonding Inventory (MIBI, Shieh et al., 2015) assessed mothers' thoughts, feelings, and commitment toward their infants. The MIBI consists of 25 items scored on 1 to 6 points. Its four factors are proximity, parental adjustment, commitment, and confidence of reciprocity. Higher scores indicate good mother-infant bonding in specific aspects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No. For confidentiality, we plan to share IPD with other researchers by contact.
Related trials for Depression, Postpartum
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
RecruitingEarly Phase 1
A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peyling Shieh, Ph. D. principal investigator
Chung Shan Medical University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interpersonal group psychotherapy in people with Depression, Postpartum and Social Adjustment, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale (time frame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.