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

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Baseline Assessment
Brief Online ACT Intervention
Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment)
Follow-up Assessment (i.e. between 8-12 weeks after baseline assessment)
Sponsored by
Hannah Palma Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Postpartum Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Holloway University of London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Brief Online ACT Intervention

Waitlist Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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)
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)

Full Information

First Posted
November 5, 2021
Last Updated
May 13, 2022
Sponsor
Hannah Palma Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT05173285
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
March 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hannah Palma Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Online ACT Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Baseline Assessment
Intervention Description
At baseline (i.e. Pre-intervention) participants will complete several questionnaires online via Qualtrics.
Intervention Type
Behavioral
Intervention Name(s)
Brief Online ACT Intervention
Intervention Description
Participants will complete the 4-week online intervention via Qualtrics
Intervention Type
Diagnostic Test
Intervention Name(s)
Post-Intervention Assessment (i.e. between 4-6 weeks after baseline assessment)
Intervention Description
Participants will complete several questionnaires online via Qualtrics.
Intervention Type
Diagnostic Test
Intervention Name(s)
Follow-up Assessment (i.e. between 8-12 weeks after baseline assessment)
Intervention Description
Participants will complete several questionnaires online via Qualtrics.
Primary Outcome Measure Information:
Title
Change in Depression on The Edinburgh Postnatal Depression Scale from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)
Description
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)
Time Frame
Baseline and Between 4 to 6 Weeks
Title
Change in Depression on The Edinburgh Postnatal Depression Scale from Baseline to Follow-up (i.e. between week 8-12 after baseline assessment)
Description
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)
Time Frame
Baseline and Between 8 to 12 Weeks
Secondary Outcome Measure Information:
Title
Change in Wellbeing Score on The Flourishing Scale from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)
Description
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)
Time Frame
Baseline and Between 4 to 6 Weeks
Title
Change in Wellbeing Score on The Flourishing Scale from Baseline to Follow Up (i.e. between week 8-12 weeks after baseline assessment)
Description
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)
Time Frame
Baseline and Between 8 to 12 Weeks
Other Pre-specified Outcome Measures:
Title
Change in Mindfulness skills on The Five Facet Mindfulness Questionnaire from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)
Description
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)
Time Frame
Baseline and Between 4 to 6 Weeks
Title
Change in Mindfulness skills on The Five Facet Mindfulness Questionnaire from Baseline to Follow Up (i.e. between week 8-12 after baseline assessment)
Description
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)
Time Frame
Baseline and Between 8 to 12 Weeks
Title
Change in Valued Living on The Valuing Questionnaire from Baseline to Post Intervention (i.e. between week 4-6 after baseline assessment)
Description
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)
Time Frame
Baseline and Between 4 to 6 Weeks
Title
Change in Valued Living on The Valuing Questionnaire from Baseline to Follow Up (i.e. between week 8-12 after baseline assessment)
Description
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)
Time Frame
Baseline and Between 8 to 12 Weeks
Title
System Usability Scale (SUS) System Usability Scale (SUS) System Usability Scale
Description
This 10-item questionnaire asks participants to rate on a 5-point Likert Scale positive and negative descriptions of the intervention.
Time Frame
Between 4 to 6 Weeks from Baseline Assessment
Title
Usefulness of the online intervention
Description
Participants asked to rate usefulness (i.e. "I found this intervention useful") on a 5-point Likert scale (1= strongly disagree - 5= strongly agree).
Time Frame
Between 4 to 6 Weeks from Baseline Assessment
Title
Satisfaction with the online intervention
Description
Participants asked to select all applicable items from a list of items relating to ways the intervention met or failed their expectations.
Time Frame
Between 4 to 6 Weeks from Baseline Assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah Palma Carlos
Organizational Affiliation
Royal Holloway University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Holloway University of London
City
Egham
State/Province
Surrey
ZIP/Postal Code
TW20 0EX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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