An interventional study of Spouse-Inclusive Social Support Educational Intervention in Pregnancy, Anxiety and COVID-19, sponsored by Atefeh Dehnoalian. Completed at 1 site in Iran. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Atefeh Dehnoalian · Not applicable, Interventional, and Prevention
The goal of this randomized controlled trial is to learn if a spouse-inclusive, social-support-based educational intervention can reduce COVID-19-related anxiety and improve perceived social support in pregnant women during public health emergencies. The main questions it aims to answer are:
Researchers will compare a group of pregnant women and their spouses who receive the seven-session educational program to a control group that receives only routine prenatal care, to see if the intervention reduces anxiety and enhances social support.
Participants will:
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 110 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
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Eligibility Criteria
Inclusion Criteria:
Gestational age of up to 34 weeks
Must be literate
Possess a registered pregnancy record at the health center
Own a smartphone
No documented history of physical or mental health disorders for either the pregnant woman or her spouse
Not involved in concurrent COVID-19 anxiety reduction programs
Exclusion Criteria:
Experience of miscarriage or preterm birth during the study timeframe
Withdrawal of consent
Researcher-identified comprehension or learning difficulties
Missing more than two intervention sessions
Pregnant women who received standard routine prenatal care only, without any supplementary training regarding social support or COVID-19 anxiety reduction.
Pregnant women and their spouses who received the seven-session, spouse-inclusive, social-support-based educational intervention in addition to routine prenatal care. The intervention consisted of seven weekly 60-minute face-to-face sessions (limited to 11 couples per session) combining interactive discussions, formal lectures, and question-and-answer segments, reinforced by supplementary virtual messages containing motivational and educational content. Sessions covered an overview of the topic, participant introduction, program guidelines, session structure, and explanation of techniques. Outcomes were assessed at baseline, immediately post-intervention, and at a one-month follow-up.
Behavioral: Spouse-Inclusive Social Support Educational Intervention
A structured, seven-session educational program attended by both pregnant women and their spouses. Sessions were conducted face-to-face on a weekly basis, lasting 60 minutes each, and were facilitated by the lead researcher. Each session was limited to 11 couples to optimize group dynamics and interaction. The pedagogical approach integrated interactive discussions, formal lectures, and question-and-answer segments, which were further reinforced by supplementary virtual messages containing motivational and educational content.
COVID-19 Anxiety
COVID-19-related anxiety measured by the Corona Disease Anxiety Scale (CDAS), an 18-item questionnaire assessing the psychological (items 1-9) and physical (items 10-18) symptoms of COVID-19-related anxiety. Responses are scored on a 4-point Likert scale ranging from 0 (never) to 3 (always), yielding a total score between 0 and 54, where higher scores indicate elevated anxiety levels. Reported Cronbach's alpha: 0.91.
Time frame: Baseline, immediately post-intervention (after seven weekly sessions), and one-month follow-up.
COVID-19 Anxiety
COVID-19-related anxiety measured by the Corona Disease Anxiety Scale (CDAS), an 18-item questionnaire assessing psychological (items 1-9) and physical (items 10-18) symptoms. Responses are scored on a 4-point Likert scale ranging from 0 (never) to 3 (always), yielding a total score between 0 and 54, with higher scores indicating elevated anxiety. Reported Cronbach's alpha: 0.91.
Time frame: Baseline, immediately post-intervention (after seven weekly sessions), and one-month follow-up.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request.
Supporting information: Study protocol, Csr
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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