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Completed

NCT Number: NCT05173285

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

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.

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Key information

Conditions

Postpartum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Holloway University of London

Egham, Surrey, TW20 0EX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baseline Assessment

Diagnostic Test

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

Brief Online ACT Intervention

Behavioral

Participants will complete the 4-week online intervention via Qualtrics

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

Diagnostic Test

Participants will complete several questionnaires online via Qualtrics.

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

Diagnostic Test

Participants will complete several questionnaires online via Qualtrics.

Primary outcomes

  1. Change in Depression on The Edinburgh Postnatal Depression Scale from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)

    Time frame: Baseline and Between 4 to 6 Weeks

    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)

  2. Change in Depression on The Edinburgh Postnatal Depression Scale from Baseline to Follow-up (i.e. between week 8-12 after baseline assessment)

    Time frame: Baseline and Between 8 to 12 Weeks

    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)

Secondary outcomes

  1. Change in Wellbeing Score on The Flourishing Scale from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)

    Time frame: Baseline and Between 4 to 6 Weeks

    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)

  2. Change in Wellbeing Score on The Flourishing Scale from Baseline to Follow Up (i.e. between week 8-12 weeks after baseline assessment)

    Time frame: Baseline and Between 8 to 12 Weeks

    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)

Other outcomes

  1. Change in Mindfulness skills on The Five Facet Mindfulness Questionnaire from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)

    Time frame: Baseline and Between 4 to 6 Weeks

    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)

  2. Change in Mindfulness skills on The Five Facet Mindfulness Questionnaire from Baseline to Follow Up (i.e. between week 8-12 after baseline assessment)

    Time frame: Baseline and Between 8 to 12 Weeks

    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)

  3. Change in Valued Living on The Valuing Questionnaire from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)

    Time frame: Baseline and Between 4 to 6 Weeks

    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)

  4. Change in Valued Living on The Valuing Questionnaire from Baseline to Follow Up (i.e. between week 8-12 after baseline assessment)

    Time frame: Baseline and Between 8 to 12 Weeks

    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)

  5. System Usability Scale (SUS) System Usability Scale (SUS) System Usability Scale

    Time frame: Between 4 to 6 Weeks from Baseline Assessment

    This 10-item questionnaire asks participants to rate on a 5-point Likert Scale positive and negative descriptions of the intervention.

  6. Usefulness of the online intervention

    Time frame: Between 4 to 6 Weeks from Baseline Assessment

    Participants asked to rate usefulness (i.e. "I found this intervention useful") on a 5-point Likert scale (1= strongly disagree - 5= strongly agree).

  7. Satisfaction with the online intervention

    Time frame: Between 4 to 6 Weeks from Baseline Assessment

    Participants asked to select all applicable items from a list of items relating to ways the intervention met or failed their expectations.

Sponsors and collaborators

Lead sponsor

Hannah Palma Carlos

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2021
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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