Postpartum Depression Clinical Trial
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
NCT number | NCT05173285 |
Other study ID # | 27112020 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 3, 2020 |
Est. completion date | March 28, 2022 |
Verified date | May 2022 |
Source | Royal Holloway University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 138 |
Est. completion date | March 28, 2022 |
Est. primary completion date | March 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Holloway University of London | Egham | Surrey |
Lead Sponsor | Collaborator |
---|---|
Hannah Palma Carlos |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Mindfulness skills on The Five Facet Mindfulness Questionnaire from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment) | 39-item questionnaire measures describing, non-reactivity, act with awareness, non-judging and observing. Items are rated on a 5-point scale ('1' -never or very rarely true, '5'- very often or always true). This study will include 31 items from the questionnaire, as it will not include the Observer factor items. This measure will be used to explore intervention specific changes in mindfulness skills.
Change = (Between week 4 to 6- Baseline Score) |
Baseline and Between 4 to 6 Weeks | |
Other | Change in Mindfulness skills on The Five Facet Mindfulness Questionnaire from Baseline to Follow Up (i.e. between week 8-12 after baseline assessment) | 39-item questionnaire measures describing, non-reactivity, act with awareness, non-judging and observing. Items are rated on a 5-point scale ('1' -never or very rarely true, '5'- very often or always true). This study will include 31 items from the questionnaire, as it will not include the Observer factor items. This measure will be used to explore intervention specific changes in mindfulness skills.
Change = (Between Week 8 to 12- Baseline Score) |
Baseline and Between 8 to 12 Weeks | |
Other | Change in Valued Living on The Valuing Questionnaire from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment) | The Valuing Questionnaire is a 10-item questionnaire measuring personal values enactment during the past week. The Valuing Questionnaire measures two constructs; progress in valued living and obstruction to valued living.
Change = (Between Week 4 to 6 - Baseline score) |
Baseline and Between 4 to 6 Weeks | |
Other | Change in Valued Living on The Valuing Questionnaire from Baseline to Follow Up (i.e. between week 8-12 after baseline assessment) | The Valuing Questionnaire is a 10-item questionnaire measuring personal values enactment during the past week. The Valuing Questionnaire measures two constructs; progress in valued living and obstruction to valued living.
Change = (Between Week 8 to 12 - Baseline score) |
Baseline and Between 8 to 12 Weeks | |
Other | System Usability Scale (SUS) System Usability Scale (SUS) System Usability Scale | This 10-item questionnaire asks participants to rate on a 5-point Likert Scale positive and negative descriptions of the intervention. | Between 4 to 6 Weeks from Baseline Assessment | |
Other | Usefulness of the online intervention | Participants asked to rate usefulness (i.e. "I found this intervention useful") on a 5-point Likert scale (1= strongly disagree - 5= strongly agree). | Between 4 to 6 Weeks from Baseline Assessment | |
Other | Satisfaction with the online intervention | Participants asked to select all applicable items from a list of items relating to ways the intervention met or failed their expectations. | Between 4 to 6 Weeks from Baseline Assessment | |
Primary | 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) | Baseline and Between 4 to 6 Weeks | |
Primary | 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) | Baseline and Between 8 to 12 Weeks | |
Secondary | 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) | Baseline and Between 4 to 6 Weeks | |
Secondary | 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) | Baseline and Between 8 to 12 Weeks |
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