Post Partum DepressionNCT04129476
Effect of a Cooperative Education Program Based on Precede-Proceed Model During Pregnancy on Postpartum Depression
A study testing Cooperative Education Program based on Precede-Proceed Model in people with Post Partum Depression, run by Gonabad University of Medical Sciences at 1 site in Iran.
Trial summary
This trail aims to evaluate the effects of a cooperative education program based on precede-proceed model during pregnancy on preventing postpartum depression in southern Razavi Khorasan Province. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Depression
- What is being tested?
- Cooperative Education Program based on Precede-Proceed Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIran
- Study dates
- 1 Nov 2019to 1 Dec 2019
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Informed consent to participate in the research
- Gestational age 30-35 weeks
- Be literate
- No history of depression or mental illness in the past
- Healthy fetus on ultrasound
Who cannot join
- Having a preterm birth
- Refusal to attend training sessions
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Gonabad University of Medical Science
Gonābād, Razavi Khorasan Province, 985157223028
Atefeh Dehnoalian, 989156453622, adehnoalian@gmail.com
About this study
This trail aims to evaluate the effects of a cooperative education program based on precede-proceed model during pregnancy on preventing postpartum depression in southern Razavi Khorasan Province.
- Conditions
- Post Partum Depression
- Being tested
- Cooperative Education Program based on Precede-Proceed Model
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooperative Education Program based on Precede-Proceed ModelBehavioural
The study population is pregnant women in Gonabad city between 30 and 35 weeks of gestation. In the experimental group, the training program was based on the PRECEDE-PROCEDURE model, including training on anatomy and prenatal physiology, prenatal and postnatal care, prenatal and postnatal mental health, as well as prenatal and postnatal events, and Mothers' feelings and attitudes, as well as postpartum problems and strategies will be discussed. The training period is 60 minutes in 4 consecutive sessions. Predisposing, reinforcing and enabling factors inventory, General health questionnaire (GHQ), Edinburgh depression inventory Will be filled Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Cooperative Education Program | Experimental | We explore the effects of a cooperative education program based on precede-proceed model during pregnancy on preventing postpartum depression. Receives: Behavioral: Cooperative Education Program based on Precede-Proceed Model |
| Control | No intervention | We provide routine care for these people during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Depression
Depression in POSTPARTUM WOMEN, usually within four weeks after giving birth (PARTURITION). The degree of depression ranges from mild transient depression to neurotic or psychotic depressive disorders. It includes 10 questions and each question is scored from 0 to 3. The total score ranges from 0 to 30 and a score of 10-13 indicates mild postpartum depression while a score of 14-15 indicates moderate postpartum depression. Score of 16 or higher is considered as severe depression which necessitates introduction to a psychologist.
Measured: Edinburgh Postnatal Depression Scale will be filled from baseline to 6 week
Secondary outcomes (2)
Predisposing, reinforcing and enabling factors inventory
for this section, a questionnaire was designed based on a literature review and according to educational and ecological Phase of precede-proceed model. Predisposing factors will be measured using 10 and 18 questions regarding knowledge and attitude, respectively. The second section of the questionnaire will be related to the enabling factors which were measured through 6 questions. Yes or no questions were designed and scored as follows: no=1, somewhat=2, yes=3. The third section of the questionnaire measures reinforcing factors through 2 questions with yes, no and somewhat answers being scored as 2, 0 and 1, respectively.
Measured: Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.
General health questionnaire (GHQ)
The General Health Questionnaire (GHQ) is a screening device for identifying minor psychiatric disorders in the general population and within community or non-psychiatric clinical settings such as primary care or general medical out-patients.it consists of 4 subscales including physical symptoms, anxiety symptoms, social functioning and depressive symptoms. Each scale is made of 7 questions which are assessed based on a Likert scale scoring as never (0), few (1), high (2) and very high (3). The total score for each person ranges from 0 to 84. Cutoff point for the questionnaire is reported to be 23. In this method, individuals with score of 23 or less are considered healthy and those with score of 24 or higher are suspected to be mentally disordered.
Measured: Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum DepressionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gonabad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atefeh Dehnoalian, Gonabad University of Medical Sciences
- Investigators
- Baloochi, Study chair, Gonabad University of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129476
- Sponsor's protocol ID
- GonabadUMS
- Status last verified
- Oct 2019
- First submitted
- 9 Oct 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Cooperative Education Program Based on Precede-Proceed Model During Pregnancy on Postpartum Depression
- ClinicalTrials.gov ID
- NCT04129476
- Acronym / sponsor ID
- GonabadUMS
- Conditions
- Post Partum Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Gonabad University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 16 Oct 2019 (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 trail aims to evaluate the effects of a cooperative education program based on precede-proceed model during pregnancy on preventing postpartum depression in southern Razavi Khorasan Province.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooperative Education Program | Experimental | Behavioral: Cooperative Education Program based on Precede-Proceed ModelWe explore the effects of a cooperative education program based on precede-proceed model during pregnancy on preventing postpartum depression. |
| Control | No intervention | –We provide routine care for these people during pregnancy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent to participate in the research
- Gestational age 30-35 weeks
- Be literate
- No history of depression or mental illness in the past
- Healthy fetus on ultrasound
Key exclusion criteria (2 listed)
- Having a preterm birth
- Refusal to attend training sessions
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 |
|---|---|---|
| Cooperative Education Program based on Precede-Proceed ModelThe study population is pregnant women in Gonabad city between 30 and 35 weeks of gestation. In the experimental group, the training program was based on the PRECEDE-PROCEDURE model, including training on anatomy and prenatal physiology, prenatal and postnatal care, prenatal and postnatal mental health, as well as prenatal and postnatal events, and Mothers' feelings and attitudes, as well as postpartum problems and strategies will be discussed. The training period is 60 minutes in 4 consecutive sessions. Predisposing, reinforcing and enabling factors inventory, General health questionnaire (GHQ), Edinburgh depression inventory Will be filled Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention. | Behavioural | Cooperative Education Program |
Primary outcome
Postpartum Depression
Time frame: Edinburgh Postnatal Depression Scale will be filled from baseline to 6 week
Depression in POSTPARTUM WOMEN, usually within four weeks after giving birth (PARTURITION). The degree of depression ranges from mild transient depression to neurotic or psychotic depressive disorders. It includes 10 questions and each question is scored from 0 to 3. The total score ranges from 0 to 30 and a score of 10-13 indicates mild postpartum depression while a score of 14-15 indicates moderate postpartum depression. Score of 16 or higher is considered as severe depression which necessitates introduction to a psychologist.
2 secondary outcomes
Predisposing, reinforcing and enabling factors inventory
Time frame: Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.
General health questionnaire (GHQ)
Time frame: Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Baloochi study chair
Gonabad University of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooperative Education Program based on Precede-Proceed Model in people with Post Partum Depression, run by Gonabad University of Medical Sciences at 1 site in Iran.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Oct 2019. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahdi Moshki (98515723028, drmoshki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Depression (time frame: Edinburgh Postnatal Depression Scale will be filled from baseline to 6 week). 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 16 Oct 2019.