Postpartum DepressionNCT05173285
Brief Internet-Based Acceptance and Commitment Therapy Intervention for Parents in the Postpartum
A study testing Baseline Assessment, Brief Online ACT Intervention and Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment) in people with Postpartum Depression, run by Hannah Palma Carlos at 1 site in United Kingdom.
Trial summary
It is common for parents in the postpartum period (the first twelve months following childbirth) to experience psychological difficulties, particularly low mood. Acceptance and Commitment Therapy (ACT) is an evidence-based intervention that aims to cultivate psychological flexibility; the ability to stay in contact… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Baseline Assessment, Brief Online ACT Intervention and Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jun 2020to 28 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18 years
- Have a child under 12 months
- Scoring 10 or above on the Edinburgh Postnatal Depression Scale
- Access to the internet through a computer, tablet or phone
- Fluency in English
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Holloway University of London
Egham, Surrey, TW20 0EX
About this study
Official title: Feasibility and Acceptability of a Brief Internet-Based Acceptance and Commitment Therapy Intervention for Parents in the Postpartum: A Feasibility Randomized Control Trial
It is common for parents in the postpartum period (the first twelve months following childbirth) to experience psychological difficulties, particularly low mood. Acceptance and Commitment Therapy (ACT) is an evidence-based intervention that aims to cultivate psychological flexibility; the ability to stay in contact with the present moment regardless of unpleasant thoughts, feelings and bodily sensations, while choosing one's behaviours based on values. Acceptance and Commitment Therapy (ACT) is effective in reducing depression in the general population, including brief ACT interventions. However, the effectiveness of ACT interventions in the postpartum period is not yet fully established.
This study aims to investigate the feasibility (recruitment source, rate and attrition rate), acceptability (usability, usefulness and satisfaction) and the potential effectiveness (to inform the required sample size for a fully powered randomised control trial) of a four week internet-based ACT intervention for postpartum parents on depression.
- Conditions
- Postpartum Depression
- Being tested
- Baseline Assessment, Brief Online ACT Intervention, Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment), Follow-up Assessment (i.e. between 8-12 weeks after baseline assessment)
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline AssessmentDiagnostic test
At baseline (i.e. Pre-intervention) participants will complete several questionnaires online via Qualtrics.
Brief Online ACT InterventionBehavioural
Participants will complete the 4-week online intervention via Qualtrics
Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment)Diagnostic test
Participants will complete several questionnaires online via Qualtrics.
Follow-up Assessment (i.e. between 8-12 weeks after baseline assessment)Diagnostic test
Participants will complete several questionnaires online via Qualtrics.
| Study group | Role | What they receive |
|---|---|---|
| Brief Online ACT Intervention | Experimental | Intervention Condition: Participants in this arm will take part in a brief ACT intervention delivered online via Qualtrics across 4-weeks; one session per week. The first two weeks will focus on mindfulness, with participants being invited to practice formal (i.e. 3-minute breathing exercise) and informal mindfulness practices (e.g. mindful walking, mindful drink etc.) during the week. The final two weeks will focus on values, specifically supporting participants to identify their personal values and set goals relating to these values. Participants have up to 6 weeks to complete the 4-week intervention. Receives: Diagnostic Test: Baseline Assessment; Behavioral: Brief Online ACT Intervention; Diagnostic Test: Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment); Diagnostic Test: Follow-up Assessment (i.e. between 8-12 weeks after baseline assessment) |
| Waitlist Control | Other | Control Condition: Participants in this arm will not receive an intervention. They will however, been given access to the brief online ACT intervention at the end of study. Receives: Diagnostic Test: Baseline Assessment; Diagnostic Test: Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment); Diagnostic Test: Follow-up Assessment (i.e. between 8-12 weeks after baseline assessment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression on The Edinburgh Postnatal Depression Scale from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)
The Edinburgh Postnatal Depression Scale is a 10-question self-rating questionnaire measuring severity of postpartum depression symptoms. Change = (Between 4 to 6 Weeks- Baseline Score)
Measured: Baseline and Between 4 to 6 Weeks
Change in Depression on The Edinburgh Postnatal Depression Scale from Baseline to Follow-up (i.e. between week 8-12 after baseline assessment)
The Edinburgh Postnatal Depression Scale is a 10-question self-rating questionnaire measuring severity of postpartum depression symptoms. Change = (Between 8 to 12 Weeks- Baseline Score)
Measured: Baseline and Between 8 to 12 Weeks
Secondary outcomes (2)
Change in Wellbeing Score on The Flourishing Scale from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)
The Flourishing scale provides a single psychological well-being score. Participants answer on a 7-point scale to what extent they agree (7) or disagree (1) with the 8 statements relating to relationships, self-esteem, purpose and optimism. Change = (Between week 4 to 6- Baseline Score)
Measured: Baseline and Between 4 to 6 Weeks
Change in Wellbeing Score on The Flourishing Scale from Baseline to Follow Up (i.e. between week 8-12 weeks after baseline assessment)
The Flourishing scale provides a single psychological well-being score. Participants answer on a 7-point scale to what extent they agree (7) or disagree (1) with the 8 statements relating to relationships, self-esteem, purpose and optimism. Change = (Between week 8 to 12- Baseline Score)
Measured: Baseline and Between 8 to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start3 Jun 2020
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannah Palma Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hannah Palma Carlos, Royal Holloway University
- Investigators
- Hannah Palma Carlos, Principal investigator, Royal Holloway University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173285
- Sponsor's protocol ID
- 27112020
- Status last verified
- May 2022
- First submitted
- 5 Nov 2021
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Brief Internet-Based Acceptance and Commitment Therapy Intervention for Parents in the Postpartum: A Feasibility Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05173285
- Acronym / sponsor ID
- 27112020
- Conditions
- Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Hannah Palma CarlosUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 29 Dec 2021 (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.
It is common for parents in the postpartum period (the first twelve months following childbirth) to experience psychological difficulties, particularly low mood. Acceptance and Commitment Therapy (ACT) is an evidence-based intervention that aims to cultivate psychological flexibility; the ability to stay in contact with the present moment regardless of unpleasant thoughts, feelings and bodily sensations, while choosing one's behaviours based on values. Acceptance and Commitment Therapy (ACT) is effective in reducing depression in the general population, including brief ACT interventions. However, the effectiveness of ACT interventions in the postpartum period is not yet fully established.
This study aims to investigate the feasibility (recruitment source, rate and attrition rate), acceptability (usability, usefulness and satisfaction) and the potential effectiveness (to inform the required sample size for a fully powered randomised control trial) of a four week internet-based ACT intervention for postpartum parents on depression.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Online ACT Intervention | Experimental | Diagnostic Test: Baseline Assessment, Behavioral: Brief Online ACT Intervention, Diagnostic Test: Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment), Diagnostic Test: Follow-up Assessment (i.e. between 8-12 weeks after baseline assessment)Intervention Condition: Participants in this arm will take part in a brief ACT intervention delivered online via Qualtrics across 4-weeks; one session per week. The first two weeks will focus on mindfulness, with participants being invited to practice formal (i.e. 3-minute breathing exercise) and informal mindfulness practices (e.g. mindful walking, mindful drink etc.) during the week. The final two weeks will focus on values, specifically supporting participants to identify their personal values and set goals relating to these values. Participants have up to 6 weeks to complete the 4-week intervention. |
| Waitlist Control | Other | Diagnostic Test: Baseline Assessment, Diagnostic Test: Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment), Diagnostic Test: Follow-up Assessment (i.e. between 8-12 weeks after baseline assessment)Control Condition: Participants in this arm will not receive an intervention. They will however, been given access to the brief online ACT intervention at the end of study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged over 18 years
- Have a child under 12 months
- Scoring 10 or above on the Edinburgh Postnatal Depression Scale
- Access to the internet through a computer, tablet or phone
- Fluency in English
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Baseline AssessmentAt baseline (i.e. Pre-intervention) participants will complete several questionnaires online via Qualtrics. | Diagnostic test | Brief Online ACT Intervention, Waitlist Control |
| Brief Online ACT InterventionParticipants will complete the 4-week online intervention via Qualtrics | Behavioural | Brief Online ACT Intervention |
| Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment)Participants will complete several questionnaires online via Qualtrics. | Diagnostic test | Brief Online ACT Intervention, Waitlist Control |
| Follow-up Assessment (i.e. between 8-12 weeks after baseline assessment)Participants will complete several questionnaires online via Qualtrics. | Diagnostic test | Brief Online ACT Intervention, Waitlist Control |
Primary outcome
Change in Depression on The Edinburgh Postnatal Depression Scale from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)
Time frame: Baseline and Between 4 to 6 Weeks
The Edinburgh Postnatal Depression Scale is a 10-question self-rating questionnaire measuring severity of postpartum depression symptoms. Change = (Between 4 to 6 Weeks- Baseline Score)
Change in Depression on The Edinburgh Postnatal Depression Scale from Baseline to Follow-up (i.e. between week 8-12 after baseline assessment)
Time frame: Baseline and Between 8 to 12 Weeks
The Edinburgh Postnatal Depression Scale is a 10-question self-rating questionnaire measuring severity of postpartum depression symptoms. Change = (Between 8 to 12 Weeks- Baseline Score)
2 secondary outcomes
Change in Wellbeing Score on The Flourishing Scale from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)
Time frame: Baseline and Between 4 to 6 Weeks
Change in Wellbeing Score on The Flourishing Scale from Baseline to Follow Up (i.e. between week 8-12 weeks after baseline assessment)
Time frame: Baseline and Between 8 to 12 Weeks
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 16 May 2022.
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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.
Hannah Palma Carlos principal investigator
Royal Holloway University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline Assessment, Brief Online ACT Intervention and Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment) in people with Postpartum Depression, run by Hannah Palma Carlos at 1 site in United Kingdom.
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 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 16 May 2022. 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 United Kingdom. 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?
Change in Depression on The Edinburgh Postnatal Depression Scale from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment) (time frame: Baseline and Between 4 to 6 Weeks). The study lists 2 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 16 May 2022.