Depression Clinical Trial
Official title:
Telephone Peer Support for New Fathers to Prevent Depressive Symptoms After the Child's Birth
The overall purpose of the pilot study is to investigate whether telephone support from fathers to fathers reduces depressive symptoms and stress among new fathers in Sweden. Forty expectant fathers with the Edinburgh Postnatal Depression Scale (EPDS)> 10 two weeks after the birth of the child are divided into two groups where half are allocated to telephone support by other fathers (intervention) as a complement to existing parental support, other group get traditionally existing parental support (control). The fathers in the intervention group were allocated telephone-based support from volunteers who have father experience, not mental illness and have undergone training through this project. These volunteers will be trained and supported by trained mentors. Four months after the child is born, data is collected with questionnaires. The intervention group will be compared with the control group and the results from the pilot study form the basis for the forthcoming RCT. Karolinska Institutet's ethics committee has approved the study. Clinical relevance: The long-term goal of this project is to improve the methods for reducing mental illness among fathers, which leads to a positive development for their children and can be used in the development of clinical guidelines to identify and reduce fathers' stress and depressive symptoms.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | January 10, 2026 |
Est. primary completion date | January 15, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 49 Years |
Eligibility | Inclusion Criteria: - Aged 18 - 49 years old, - Less than two weeks postpartum - Scored more than ten on the -Edingburg postnatal depression scale (EPDS ) scale <10 = indicate depression - Swedish or English speaking Exclusion Criteria: - Current use of anti-depressant or anti-psychotic medication |
Country | Name | City | State |
---|---|---|---|
Sweden | Eva andersson | Huddinge | Stockholms Län |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Satisfaction with telephone peer support | Satisfaction with telephone peer support is assesed by measure with study construction question | follow up 3 months after the intervention | |
Primary | Changes of Postpartum Depressive symptoms | Changes in Postpartum Depressive symptoms (PPD), assesed by measured by EPDS (Edinburg postpartumdepression scale) more than 10 score on EPDS= indicate depressive symptoms for fathers, minimum=0 maximum=30 Postpartum Depressive symptoms (PPD), as measured by EPDS (Edinburg postnatal depression scale (Cox et al 1994) | Baseline and follow up 3 months and one year after the invention | |
Secondary | Changes of Anxiety symptoms | Anxiety will be measured using the Spielberger State-Anxiety Inventory (STAI-State), a 20-item self-report instrument developed to assess levels of relatively transient situation-related (state) anxiety. Items are rated on a 4-point Likert-type scale to produce a summative score ranging from 20 to 80 with higher scores indicating higher levels of anxiety. | Baseline and follow up 3 months and one year after the invention |
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