Mental HealthNCT06405932
Study of the Intervention Effect of Self-help Training Camps in Promoting Mental Health Among Perinatal Women
A study testing Mental Fitness Training Camp in people with Mental Health and Perinatal Depression, run by Fangbiao Tao at 1 site in China.
Trial summary
This study was a multi-center randomized controlled trial of an Internet-based self-help mental fitness training camp intervention that included women in early, mid, and late pregnancy with or without psychological distress. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Perinatal Depression
- What is being tested?
- Mental Fitness Training Camp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,691 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2024to 1 Oct 2025
- Phase
- Interventional
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women
- The gestational week in early pregnancy is 0 to 13 weeks; the gestational week in mid-pregnancy is 14 to 27 weeks; and the gestational week in late pregnancy is 28 to 32 weeks.
- Intention to have children in this pregnancy.
- Ability to understand and complete the questionnaire independently.
- Informed consent and voluntary participation in this study.
Who cannot join
- Suffering from depression being treated with psychotherapy or medication.
- The presence of a serious mental illness or intellectual disability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center Randomized Controlled Trial : Study of the Intervention Effect of "a Self-help Mental Fitness Training Camp"on Depression Symptoms During Pregnancy
This study was a multi-center randomized controlled trial of an Internet-based self-help mental fitness training camp intervention that included women in early, mid, and late pregnancy with or without psychological distress. A comparison was conducted between the intervention and control groups with regard to depression and anxiety scores during pregnancy and at 42 days postpartum in order to ascertain the efficacy of a self-help mental fitness training camp in preventing negative emotions among perinatal women. In addition, associations between different modes of intervention and maternal and infant outcomes were investigated.
Read the detailed description
In this study, the principle of "early detection, early diagnosis and early treatment" was used to screen and manage negative emotions such as anxiety and depression in three time windows: early pregnancy, mid-pregnancy and late pregnancy. All weeks from June to December 2024 were randomly divided into intervention and control weeks. Pregnant women were assigned to the intervention or control group according to the week of their visit to the hospital for obstetric examination. The intervention group of pregnant women participated in a three-week program of mental fitness training, while the control group received standard care.
The participants were evaluated on multiple occasions following their enrollment in the study. These evaluations occurred at the baseline stage, immediately following the intervention, during the mid and late stages of pregnancy, and 42 days after delivery.
- Conditions
- Mental Health, Perinatal Depression
- Being tested
- Mental Fitness Training Camp
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Fitness Training CampCombination product
The Mental Fitness Training camp employs and incorporates core learning content derived from Cognitive Behavioral Therapy and Mindfulness. The program comprises nine thought animations, emotional diary, daily breathing exercises, and pleasure lists.
| Study group | Role | What they receive |
|---|---|---|
| Mental Fitness Training Camp | Experimental | The self-help mental fitness training camp, comprising 21 learning modules structured around animated thinking videos, audio, text, and moving images, lasts 21 days. Each learning module is automatically pushed to the intervention group on a daily basis, with an estimated completion time of 30-50 minutes. Receives: Combination Product: Mental Fitness Training Camp |
| health education | No intervention | The control group received routine-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale
The scale is employed to assess the severity of depression and comprises 10 items, each of which is scored on a 0 to 3 point scale. A total score of 0 to 9 indicates a negative result, 10 to 12 indicates mild depression, 13 to 16 indicates moderate depression, and a score greater than or equal to 17 indicates severe depression.
Measured: 0, 3 weeks, 42 days postpartum
Generalized Anxiety Disorder
The scale is designed to assess the severity of an individual\'s anxiety symptoms over the past two weeks. It comprises seven entries, each rated on a scale of 0 to 3. A total score of 5 to 9 is indicative of mild anxiety, 10 to 14 of moderate anxiety, and a score of 15 or above of severe anxiety.
Measured: 0, 3 weeks, 42 days postpartum
Secondary outcomes (2)
Maternal and infant endings
Maternal pregnancy outcomes and general neonatal outcomes were collected via self-administered scales.
Measured: 42 days postpartum
World Health Organization Five-item Well-Being Index
The scale in question assesses well-being, with higher total scores representing higher levels of well-being.
Measured: 0, 3 weeks, 42 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start11 Sep 2024
- Primary completion1 Sep 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies 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
- Outcomes assessor
- Enrolment
- 1,691 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fangbiao Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fangbiao Tao, Anhui Medical University
- Investigators
- Chengli Tang, Study director, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405932
- Sponsor's protocol ID
- 202451
- Status last verified
- Dec 2025
- First submitted
- 5 May 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No