Clinical trial NCT05173285: Brief Internet-Based Acceptance and Commitment Therapy Intervention for Parents in the Postpartum
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: Royal Holloway University
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Depression on The Edinburgh Postnatal Depression Scale from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)
timeFrame: Baseline and Between 4 to 6 Weeks
measure: Change in Depression on The Edinburgh Postnatal Depression Scale from Baseline to Follow-up (i.e. between week 8-12 after baseline assessment)
timeFrame: Baseline and Between 8 to 12 Weeks
Secondary outcomes:
measure: Change in Wellbeing Score on The Flourishing Scale from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)
timeFrame: Baseline and Between 4 to 6 Weeks
measure: Change in Wellbeing Score on The Flourishing Scale from Baseline to Follow Up (i.e. between week 8-12 weeks after baseline assessment)
timeFrame: Baseline and Between 8 to 12 Weeks
Other outcomes:
measure: Change in Mindfulness skills on The Five Facet Mindfulness Questionnaire from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)
timeFrame: Baseline and Between 4 to 6 Weeks
measure: Change in Mindfulness skills on The Five Facet Mindfulness Questionnaire from Baseline to Follow Up (i.e. between week 8-12 after baseline assessment)
timeFrame: Baseline and Between 8 to 12 Weeks
measure: Change in Valued Living on The Valuing Questionnaire from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)
timeFrame: Baseline and Between 4 to 6 Weeks
measure: Change in Valued Living on The Valuing Questionnaire from Baseline to Follow Up (i.e. between week 8-12 after baseline assessment)
timeFrame: Baseline and Between 8 to 12 Weeks
measure: System Usability Scale (SUS) System Usability Scale (SUS) System Usability Scale
timeFrame: Between 4 to 6 Weeks from Baseline Assessment
measure: Usefulness of the online intervention
timeFrame: Between 4 to 6 Weeks from Baseline Assessment
measure: Satisfaction with the online intervention
timeFrame: Between 4 to 6 Weeks from Baseline Assessment
Locations:
city: Egham
country: United Kingdom
facility: Royal Holloway University of London
state: Surrey
Study officials:
affiliation: Royal Holloway University
name: Hannah Palma Carlos
role: PRINCIPAL_INVESTIGATOR
References: