Skip to main content
OpenTrials
Completed

NCT Number: NCT02434406

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Disorders Behavior Health Behavior Mental Disorders Patient Acceptance of Health Care Personal Satisfaction Psychological Well-Being Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

City, University of London, London, Greater London, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

internet-What Am I Worried About

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.

Primary outcomes

  1. Engagement as measured by the number of log-ins into the web-based intervention

    Time frame: At time of intervention (8 weeks)

  2. Engagement as measured by the duration of log-ins into the web-based intervention

    Time frame: At time of intervention (8 weeks)

  3. Engagement as measured by the total duration of time spent on the web-based intervention

    Time frame: At time of intervention (8 weeks)

  4. Engagement as measured by the time spent on individual pages of the web-based intervention

    Time frame: At time of intervention (8 weeks)

  5. Engagement as measured by the number of intervention coach calls

    Time frame: At time of intervention (8 weeks)

  6. 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).

    Time frame: At time of intervention (8 weeks) after each completed intervention module

  7. 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).

    Time frame: At time of intervention (8 weeks) after each completed intervention module

  8. Usability as measured by participant's report of usability on the System Usability Scale (SUS)

    Time frame: Within 2 weeks after the intervention

    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.

  9. 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)

    Time frame: Within 2 weeks after the intervention

  10. Usability as measured by participant's report of any technical problems experienced with the intervention website

    Time frame: Within 2 weeks after the intervention

  11. Usability as measured by participant's report of interest in future usage of the intervention

    Time frame: Within 2 weeks after the intervention

  12. 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).

    Time frame: Within 2 weeks after the intervention

  13. 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).

    Time frame: Within 2 weeks after the intervention

  14. Satisfaction as measured by participant's report on the Client Satisfaction Questionnaire (CSQ-8)

    Time frame: Within 2 weeks after the intervention

    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.

  15. Credibility as measured by participant's report on the first 4 items of Credibility/ Expectancy Questionnaire (CEQ)

    Time frame: Within 2 weeks after the intervention

    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.

  16. Women's perspectives and experiences as measured by semi-structured interviews

    Time frame: Within 8 weeks after the intervention

  17. Engagement as measured by the duration of intervention coach calls

    Time frame: Continuous throughout the 8 week intervention period

  18. Usability as measured by participant's report of hypothetical recommendation of the intervention to others.

    Time frame: Within 2 weeks after the intervention

Secondary outcomes

  1. Anxiety level as measured by participant's report on the Generalized Anxiety Disorder Scale (GAD-7)

    Time frame: Within 1 week before the intervention

    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).

  2. Depression, anxiety and stress symptomatology as measured by participant's report on the Depression, Anxiety, and Stress Scale (DASS 21)

    Time frame: Within 1 week before the intervention

    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.

  3. Anxiety level as measured by participant's report on the Generalized Anxiety Disorder Scale (GAD-7)

    Time frame: Within 1 week after the intervention

    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).

  4. Depression, anxiety and stress symptomatology as measured by participant's report on the Depression, Anxiety, and Stress Scale (DASS 21)

    Time frame: Within 1 week after the intervention

    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.

  5. Anxiety level as measured by participant's report on the Generalized Anxiety Disorder Scale (GAD-7)

    Time frame: Within 1 week after the end of the 4 week post-intervention follow-up period

    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).

  6. Depression, anxiety and stress symptomatology as measured by participant's report on the Depression, Anxiety, and Stress Scale (DASS 21)

    Time frame: Within 1 week after the end of the 4 week post-intervention follow-up period

    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.

  7. Study feasibility as measured by recruitment rate

    Time frame: Within 4 weeks of ending recruitment

  8. Study feasibility as measured by eligibility rate

    Time frame: Within 4 weeks of ending recruitment

  9. Study feasibility as measured by consent rate

    Time frame: Within 4 weeks of ending recruitment

  10. Study feasibility as measured by retention rate

    Time frame: Within 4 weeks of ending data collection

  11. Study feasibility as measured by pre-intervention data collection rate

    Time frame: Within 4 weeks of ending data collection

  12. Study feasibility as measured by pre-intervention data collection completeness

    Time frame: Within 4 weeks of ending data collection

  13. Study feasibility as measured by post-intervention data collection rate

    Time frame: Within 4 weeks of ending data collection

  14. Study feasibility as measured by post-intervention data collection completeness

    Time frame: Within 4 weeks of ending data collection

  15. Study feasibility as measured by 4 week post intervention follow-up data collection rate

    Time frame: Within 4 weeks of ending data collection

  16. Study feasibility as measured by 4 week post intervention follow-up data collection completeness

    Time frame: Within 4 weeks of ending data collection

Sponsors and collaborators

Lead sponsor

City, University of London

Other

Collaborators

  • Monash University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 5, 2015
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.