Website-Based Self-Help for Women With Anxiety After Childbirth

NCT ID: NCT02434406

Last Updated: 2018-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-26
• Study Completion Date: 2017-08-30

Brief Summary

This study examines the feasibility and acceptability of a web-based intervention program for women with anxiety after childbirth, potential anxiety reduction after the intervention and determines the feasibility of the study design (randomized controlled design) and recruitment for the intervention in this population to inform the protocol (including effect size and study power) for a randomized controlled trial.

Detailed Description

Background: What Am I Worried About (WAWA) is a self-help booklet intervention for women experiencing anxiety after birth based on cognitive-behavioural and mindfulness principles developed in Australia. The WAWA booklet was found to be acceptable, safe, stigma free, feasible, and demonstrated preliminary efficacy in Australia. A web-based version of WAWA for the use in the United-Kingdom (UK) was developed at City University London in collaboration with the intervention development team in Australia. However, before dissemination the web-based version of WAWA (iWAWA) in the UK it is deemed important to evaluate the program. Therefore, this study aims to examine the feasibility, acceptability, and potential efficacy of this web-based intervention program for women with anxiety after childbirth in the UK.

The primary objectives of the proposed study are to:

conduct a randomized controlled trial and

• examine the feasibility of web-based treatment program (iWAWA) in terms of engagement and usability.
• examine user's acceptability of iWAWA in terms of usefulness, satisfaction, and credibility.

The secondary objectives of this study are to:

• obtain initial estimates of anxiety levels and examine potential patient improvement over the course of the intervention and compared to the control group.
• determine the feasibility of the study by examining recruitment, consent, attrition, follow-up rates, as well as response rates to questionnaires.

Method: For this feasibility study, an embedded mixed methods design is employed utilizing both quantitative and qualitative methods to achieve the above stated aims. For the quantitative part, a randomized control trial is conducted. Outcomes are assessed at pre-intervention, throughout the intervention, post-intervention, and 1-month post-intervention. For the qualitative part, semi-structured interviews are used for a more in-depth exploration of acceptability and feasibility of the iWAWA intervention. The interviews with participants are carried out post intervention.

Study benefits: Based on the participants' feedback, this study hopes to inform development and adaptation of the investigated web-based intervention. If the interventions acceptability and feasibility is confirmed, the next steps would be to test the intervention efficacy in a stage II randomized control trial.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Web-based intervention

Participants get access to the web-based intervention and are asked to work through the 8 modules of the intervention within eight weeks. The intervention program sends automated weekly email reminders about the current session. In addition, users are offered weekly optional 30-minute telephone support with a trained intervention coach.

Group Type: EXPERIMENTAL

internet-What Am I Worried About

Intervention Type: BEHAVIORAL

This web-based intervention consists of three sections: 1) Is this for me? 2) Practice 3) Understanding. The three main sections are divided up into nine sessions. Participants will get access to the program for eight weeks and can access the sessions more than once. Sessions are made up of multimedia presentations and worksheets that are completed online.

Wait-list control

Participants get standard care and will be offered access to the web-based intervention at 8-weeks post-randomization.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

internet-What Am I Worried About

This web-based intervention consists of three sections: 1) Is this for me? 2) Practice 3) Understanding. The three main sections are divided up into nine sessions. Participants will get access to the program for eight weeks and can access the sessions more than once. Sessions are made up of multimedia presentations and worksheets that are completed online.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Women who are within the first 12 months postpartum (at the beginning of the intervention)
• Aged over 18
• Living in England
• Sufficient knowledge of written and spoken English
• Access to internet at home
• Report a score of ≥5 on the Generalized Anxiety Disorder Scale (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)

Exclusion Criteria

• Still birth or perinatal death of latest baby
• Latest baby seriously ill
• Report self-harm or suicidal ideation
• Currently receiving formal psychotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Monash University

OTHER

Sponsor Role: collaborator

City, University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miriam T Ashford, MS, cand.PhD

Role: PRINCIPAL_INVESTIGATOR

City, University of London

Susan Ayers, Professor

Role: PRINCIPAL_INVESTIGATOR

City, University of London

Locations

City, University of London

London, Greater London, United Kingdom

City University of London

London, , United Kingdom

Countries

United Kingdom

References

Rowe HJ; Calcagni SC; Galgut S; Michelmore J; Fisher, JRW. Self-management of mild to moderate anxiety in women who have recently given birth: Development and acceptability of a theoretically sound complex intervention. International Journal of Mental Health Promotion 2014 Oct; 16(5): 308-319. doi:10.1080/14623730.2014.964050

Reference Type: BACKGROUND

Ashford MT, Olander EK, Rowe H, Fisher JR, Ayers S. Feasibility and Acceptability of a Web-Based Treatment with Telephone Support for Postpartum Women With Anxiety: Randomized Controlled Trial. JMIR Ment Health. 2018 Apr 20;5(2):e19. doi: 10.2196/mental.9106.

Reference Type: DERIVED

PMID: 29678804 (View on PubMed)

Other Identifiers

PhD/14-15/16

Identifier Type: -

Identifier Source: org_study_id