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

NCT05173285 | Completed

• 1 other identifier: 27112020
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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 Weeks

• 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 Weeks

Other Outcomes (7)

• 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 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)

  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)

  Baseline and Between 4 to 6 Weeks

Study Arms (2)

Brief Online ACT Intervention

EXPERIMENTAL

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; 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)

Waitlist Control

OTHER

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; 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)

Interventions

Baseline Assessment DIAGNOSTIC_TEST

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

Brief Online ACT Intervention; Waitlist Control

Brief Online ACT Intervention BEHAVIORAL

Participants will complete the 4-week online intervention via Qualtrics

Brief Online ACT Intervention

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

Participants will complete several questionnaires online via Qualtrics.

Brief Online ACT Intervention; Waitlist Control

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

Participants will complete several questionnaires online via Qualtrics.

Brief Online ACT Intervention; Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Hannah Palma Carlos: lead

Study Sites (1)

Royal Holloway University of London

Egham, Surrey, TW20 0EX, United Kingdom

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Hannah Palma Carlos

  Royal Holloway University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 29, 2021
• Study Start: June 3, 2020
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2022
• Last Updated: May 16, 2022

Record last verified: 2022-05

Locations

GB (1)