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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2022
Source Royal Holloway University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Baseline Assessment
At baseline (i.e. Pre-intervention) participants will complete several questionnaires online via Qualtrics.
Behavioral:
Brief Online ACT Intervention
Participants will complete the 4-week online intervention via Qualtrics
Diagnostic Test:
Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment)
Participants will complete several questionnaires online via Qualtrics.
Follow-up Assessment (i.e. between 8-12 weeks after baseline assessment)
Participants will complete several questionnaires online via Qualtrics.

Locations

Country Name City State
United Kingdom Royal Holloway University of London Egham Surrey

Sponsors (1)

Lead Sponsor Collaborator
Hannah Palma Carlos

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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