NCT02434406

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

Feasibility of a Web-Based Intervention for Women With Postpartum Anxiety: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: City, University of London · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2017-03-26
• Primary completion: 2017-08-30
• Completion: 2017-08-30
• First posted: 2015-05-05
• Last updated: 2018-01-31

Locations

2 sites across 1 country: United Kingdom