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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: internet-What Am I Worried About


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based intervention<br>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. | Behavioral: internet-What Am I Worried About<br>* 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.<br>|
| No Intervention: Wait-list control<br>Participants get standard care and will be offered access to the web-based intervention at 8-weeks post-randomization. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement as measured by the number of log-ins into the web-based intervention |  | At time of intervention (8 weeks) | 
| Engagement as measured by the duration of log-ins into the web-based intervention |  | At time of intervention (8 weeks) | 
| Engagement as measured by the total duration of time spent on the web-based intervention |  | At time of intervention (8 weeks) | 
| Engagement as measured by the time spent on individual pages of the web-based intervention |  | At time of intervention (8 weeks) | 
| Engagement as measured by the number of intervention coach calls |  | At time of intervention (8 weeks) | 
| Usability as measured by participant's report of usefulness (I found this module useful.) of each intervention module on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). |  | At time of intervention (8 weeks) after each completed intervention module | 
| Usability as measured by participant's report of clarity (This module was clear and understandable.) of each intervention module on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). |  | At time of intervention (8 weeks) after each completed intervention module | 
| Usability as measured by participant's report of usability on the System Usability Scale (SUS) | The System Usability Scale (SUS) is a 10-item instrument rated on 5-point Likert scale (1 = strongly disagree to 5 = strongly agree) and participants are asked to rate the degree to which they agree with positive and negative descriptions of a program. The SUS will be adapted for this study by replacing 'the system/product' with 'iWAWA' for all items. Higher scores indicate better usability. | Within 2 weeks after the intervention | 
| Usability as measured by participant's report of usability on a series of items designed to measure ease-of-use and unobtrusiveness on 7-point Likert scale (1 = strongly disagree to 7 = strongly agree) |  | Within 2 weeks after the intervention | 
| Usability as measured by participant's report of any technical problems experienced with the intervention website |  | Within 2 weeks after the intervention | 
| Usability as measured by participant's report of interest in future usage of the intervention |  | Within 2 weeks after the intervention | 
| Usefulness as measured by participant's report of a series of items designed to measure perceived usefulness on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). |  | Within 2 weeks after the intervention | 
| Satisfaction as measured by participant's report of a series of items designed to measure perceived satisfaction on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). |  | Within 2 weeks after the intervention | 
| Satisfaction as measured by participant's report on the Client Satisfaction Questionnaire (CSQ-8) | The Client Satisfaction Questionnaire (CSQ-8) will further be used and adapted to assess satisfaction. The CSQ-8 consists of eight items which are rated on 5-point Likert scale. The CSQ-8 will be adapted for this study by substituting 'service' with 'help and program with iWAWA in all items. | Within 2 weeks after the intervention | 
| Credibility as measured by participant's report on the first 4 items of Credibility/ Expectancy Questionnaire (CEQ) | The Credibility/ Expectancy Questionnaire (CEQ) is a 6-item widely applied measure of the expectancies or perception of intervention credibility and will be adapted for the use in this study. | Within 2 weeks after the intervention | 
| Women's perspectives and experiences as measured by semi-structured interviews |  | Within 8 weeks after the intervention | 
| Engagement as measured by the duration of intervention coach calls |  | Continuous throughout the 8 week intervention period | 
| Usability as measured by participant's report of hypothetical recommendation of the intervention to others. |  | Within 2 weeks after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety level as measured by participant's report on the Generalized Anxiety Disorder Scale (GAD-7) | The Generalized Anxiety Disorder Scale (GAD-7) is a seven-item anxiety measure and items are rated on 4-point Likert-scale ranging from 0' (not at all) to '3' (nearly every day). | Within 1 week before the intervention | 
| Depression, anxiety and stress symptomatology as measured by participant's report on the Depression, Anxiety, and Stress Scale (DASS 21) | The Depression, Anxiety, and Stress Scale (DASS 21) is a 21-item self-report measure of current depressive, anxiety, and stress symptoms. Low positive affect, reduced self-esteem and motivation, and a sense of hopelessness is assessed by seven depression items; fearfulness and physiological arousal is assessed by seven anxiety items, and tension, irritability and a low threshold to frustration are measured by seven stress items. Higher scores indicate more severe symptoms. | Within 1 week before the intervention | 
| Anxiety level as measured by participant's report on the Generalized Anxiety Disorder Scale (GAD-7) | The Generalized Anxiety Disorder Scale (GAD-7) is a seven-item anxiety measure and items are rated on 4-point Likert-scale ranging from 0' (not at all) to '3' (nearly every day). | Within 1 week after the intervention | 
| Depression, anxiety and stress symptomatology as measured by participant's report on the Depression, Anxiety, and Stress Scale (DASS 21) | The Depression, Anxiety, and Stress Scale (DASS 21) is a 21-item self-report measure of current depressive, anxiety, and stress symptoms. Low positive affect, reduced self-esteem and motivation, and a sense of hopelessness is assessed by seven depression items; fearfulness and physiological arousal is assessed by seven anxiety items, and tension, irritability and a low threshold to frustration are measured by seven stress items. Higher scores indicate more severe symptoms. | Within 1 week after the intervention | 
| Anxiety level as measured by participant's report on the Generalized Anxiety Disorder Scale (GAD-7) | The Generalized Anxiety Disorder Scale (GAD-7) is a seven-item anxiety measure and items are rated on 4-point Likert-scale ranging from 0' (not at all) to '3' (nearly every day). | Within 1 week after the end of the 4 week post-intervention follow-up period | 
| Depression, anxiety and stress symptomatology as measured by participant's report on the Depression, Anxiety, and Stress Scale (DASS 21) | The Depression, Anxiety, and Stress Scale (DASS 21) is a 21-item self-report measure of current depressive, anxiety, and stress symptoms. Low positive affect, reduced self-esteem and motivation, and a sense of hopelessness is assessed by seven depression items; fearfulness and physiological arousal is assessed by seven anxiety items, and tension, irritability and a low threshold to frustration are measured by seven stress items. Higher scores indicate more severe symptoms. | Within 1 week after the end of the 4 week post-intervention follow-up period | 
| Study feasibility as measured by recruitment rate |  | Within 4 weeks of ending recruitment | 
| Study feasibility as measured by eligibility rate |  | Within 4 weeks of ending recruitment | 
| Study feasibility as measured by consent rate |  | Within 4 weeks of ending recruitment | 
| Study feasibility as measured by retention rate |  | Within 4 weeks of ending data collection | 
| Study feasibility as measured by pre-intervention data collection rate |  | Within 4 weeks of ending data collection | 
| Study feasibility as measured by pre-intervention data collection completeness |  | Within 4 weeks of ending data collection | 
| Study feasibility as measured by post-intervention data collection rate |  | Within 4 weeks of ending data collection | 
| Study feasibility as measured by post-intervention data collection completeness |  | Within 4 weeks of ending data collection | 
| Study feasibility as measured by 4 week post intervention follow-up data collection rate |  | Within 4 weeks of ending data collection | 
| Study feasibility as measured by 4 week post intervention follow-up data collection completeness |  | Within 4 weeks of ending data collection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Anxiety disorders, Mental health, Postpartum period, maternal welfare, internet, intervention studies, feasibility studies, randomized controlled trial, patient acceptance of health care