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

NCT ID: NCT05173285

Last Updated: 2022-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-03

Study Completion Date

2022-03-28

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.

Detailed Description

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Conditions

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Postpartum Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Brief Online ACT Intervention

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.

Group Type EXPERIMENTAL

Baseline Assessment

Intervention Type DIAGNOSTIC_TEST

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

Brief Online ACT Intervention

Intervention Type BEHAVIORAL

Participants will complete the 4-week online intervention via Qualtrics

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

Intervention Type DIAGNOSTIC_TEST

Participants will complete several questionnaires online via Qualtrics.

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

Intervention Type DIAGNOSTIC_TEST

Participants will complete several questionnaires online via Qualtrics.

Waitlist Control

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.

Group Type OTHER

Baseline Assessment

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DIAGNOSTIC_TEST

Participants will complete several questionnaires online via Qualtrics.

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

Intervention Type DIAGNOSTIC_TEST

Participants will complete several questionnaires online via Qualtrics.

Interventions

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Baseline Assessment

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

Intervention Type DIAGNOSTIC_TEST

Brief Online ACT Intervention

Participants will complete the 4-week online intervention via Qualtrics

Intervention Type BEHAVIORAL

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

Participants will complete several questionnaires online via Qualtrics.

Intervention Type DIAGNOSTIC_TEST

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

Participants will complete several questionnaires online via Qualtrics.

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannah Palma Carlos

OTHER

Sponsor Role lead

Responsible Party

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Hannah Palma Carlos

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hannah Palma Carlos

Role: PRINCIPAL_INVESTIGATOR

Royal Holloway University

Locations

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Royal Holloway University of London

Egham, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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27112020

Identifier Type: -

Identifier Source: org_study_id

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