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

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility and Acceptability of a Brief Internet-Based Acceptance and Commitment Therapy Intervention for Parents in the Postpartum: A Feasibility Randomized Control Trial

Conditions
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Postpartum Depression

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief Online ACT Intervention<br>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<br>* At baseline (i.e. Pre-intervention) participants will complete several questionnaires online via Qualtrics.<br>Behavioral: Brief Online ACT Intervention<br>* Participants will complete the 4-week online intervention via Qualtrics<br>Diagnostic Test: Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment)<br>* Participants will complete several questionnaires online via Qualtrics.<br>Diagnostic Test: Follow-up Assessment (i.e. between 8-12 weeks after baseline assessment)<br>* Participants will complete several questionnaires online via Qualtrics.<br>|
| Other: Waitlist Control<br>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<br>* At baseline (i.e. Pre-intervention) participants will complete several questionnaires online via Qualtrics.<br>Diagnostic Test: Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment)<br>* Participants will complete several questionnaires online via Qualtrics.<br>Diagnostic Test: Follow-up Assessment (i.e. between 8-12 weeks after baseline assessment)<br>* Participants will complete several questionnaires online via Qualtrics.<br>|

What is the study measuring?
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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 |