Brief Internet-Based Acceptance and Commitment Therapy Intervention for Parents in the Postpartum

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05173285
• Other study ID #: 27112020
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Depression, Postpartum
• Postpartum Depression

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