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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05173285
Enrollment
138
Registered
2021-12-29
Start date
2020-06-03
Completion date
2022-03-28
Last updated
2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Depression

Brief 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.

Interventions

DIAGNOSTIC_TESTBaseline Assessment

At baseline (i.e. Pre-intervention) participants will complete several questionnaires online via Qualtrics.

BEHAVIORALBrief Online ACT Intervention

Participants will complete the 4-week online intervention via Qualtrics

DIAGNOSTIC_TESTPost-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment)

Participants will complete several questionnaires online via Qualtrics.

DIAGNOSTIC_TESTFollow-up Assessment (i.e. between 8-12 weeks after baseline assessment)

Participants will complete several questionnaires online via Qualtrics.

Sponsors

Hannah Palma Carlos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Depression on The Edinburgh Postnatal Depression Scale from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)Baseline and Between 4 to 6 WeeksThe 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)Baseline and Between 8 to 12 WeeksThe 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)

Secondary

MeasureTime frameDescription
Change in Wellbeing Score on The Flourishing Scale from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)Baseline and Between 4 to 6 WeeksThe 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)
Change in Wellbeing Score on The Flourishing Scale from Baseline to Follow Up (i.e. between week 8-12 weeks after baseline assessment)Baseline and Between 8 to 12 WeeksThe 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)

Other

MeasureTime frameDescription
System Usability Scale (SUS) System Usability Scale (SUS) System Usability ScaleBetween 4 to 6 Weeks from Baseline AssessmentThis 10-item questionnaire asks participants to rate on a 5-point Likert Scale positive and negative descriptions of the intervention.
Change in Mindfulness skills on The Five Facet Mindfulness Questionnaire from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)Baseline and Between 4 to 6 Weeks39-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)
Satisfaction with the online interventionBetween 4 to 6 Weeks from Baseline AssessmentParticipants asked to select all applicable items from a list of items relating to ways the intervention met or failed their expectations.
Usefulness of the online interventionBetween 4 to 6 Weeks from Baseline AssessmentParticipants asked to rate usefulness (i.e. I found this intervention useful) on a 5-point Likert scale (1= strongly disagree - 5= strongly agree).
Change in Mindfulness skills on The Five Facet Mindfulness Questionnaire from Baseline to Follow Up (i.e. between week 8-12 after baseline assessment)Baseline and Between 8 to 12 Weeks39-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)
Change in Valued Living on The Valuing Questionnaire from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)Baseline and Between 4 to 6 WeeksThe 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)
Change in Valued Living on The Valuing Questionnaire from Baseline to Follow Up (i.e. between week 8-12 after baseline assessment)Baseline and Between 8 to 12 WeeksThe 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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026