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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Depression
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Egham, Surrey, United Kingdom, TW20 0EX
      • Royal Holloway University of London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief Online ACT Intervention; 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.	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.; Diagnostic test: Follow-up Assessment (i.e. between 8-12 weeks after baseline assessment); Participants will complete several questionnaires online via Qualtrics.
Other: Waitlist Control; 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.	Diagnostic test: Baseline Assessment; At baseline (i.e. Pre-intervention) participants will complete several questionnaires online via Qualtrics.; Diagnostic test: Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment); Participants will complete several questionnaires online via Qualtrics.; Diagnostic test: Follow-up Assessment (i.e. between 8-12 weeks after baseline assessment); Participants will complete several questionnaires online via Qualtrics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hannah Palma Carlos
• Investigators: Principal Investigator: Hannah Palma Carlos, Royal Holloway University

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2020
• Primary Completion (Actual): March 28, 2022
• Study Completion (Actual): March 28, 2022

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 27112020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No