Clinical trial NCT02434406: Website-Based Self-Help for Women With Anxiety After Childbirth
Official title: Feasibility of a Web-Based Intervention for Women With Postpartum Anxiety: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: Anxiety
Anxiety disorders
Mental health
Postpartum period
maternal welfare
internet
intervention studies
feasibility studies
randomized controlled trial
patient acceptance of health care
Lead sponsor: City, University of London
Sponsor class: OTHER
Collaborators: name: Monash University
First posted: 2015-05-05
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Engagement as measured by the number of log-ins into the web-based intervention
timeFrame: At time of intervention (8 weeks)
measure: Engagement as measured by the duration of log-ins into the web-based intervention
timeFrame: At time of intervention (8 weeks)
measure: Engagement as measured by the total duration of time spent on the web-based intervention
timeFrame: At time of intervention (8 weeks)
measure: Engagement as measured by the time spent on individual pages of the web-based intervention
timeFrame: At time of intervention (8 weeks)
measure: Engagement as measured by the number of intervention coach calls
timeFrame: At time of intervention (8 weeks)
measure: 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).
timeFrame: At time of intervention (8 weeks) after each completed intervention module
measure: 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).
timeFrame: At time of intervention (8 weeks) after each completed intervention module
measure: Usability as measured by participant's report of usability on the System Usability Scale (SUS)
timeFrame: Within 2 weeks after the intervention
measure: 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)
timeFrame: Within 2 weeks after the intervention
measure: Usability as measured by participant's report of any technical problems experienced with the intervention website
timeFrame: Within 2 weeks after the intervention
measure: Usability as measured by participant's report of interest in future usage of the intervention
timeFrame: Within 2 weeks after the intervention
measure: 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).
timeFrame: Within 2 weeks after the intervention
measure: 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).
timeFrame: Within 2 weeks after the intervention
measure: Satisfaction as measured by participant's report on the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Within 2 weeks after the intervention
measure: Credibility as measured by participant's report on the first 4 items of Credibility/ Expectancy Questionnaire (CEQ)
timeFrame: Within 2 weeks after the intervention
measure: Women's perspectives and experiences as measured by semi-structured interviews
timeFrame: Within 8 weeks after the intervention
measure: Engagement as measured by the duration of intervention coach calls
timeFrame: Continuous throughout the 8 week intervention period
measure: Usability as measured by participant's report of hypothetical recommendation of the intervention to others.
timeFrame: Within 2 weeks after the intervention
Secondary outcomes:
measure: Anxiety level as measured by participant's report on the Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Within 1 week before the intervention
measure: Depression, anxiety and stress symptomatology as measured by participant's report on the Depression, Anxiety, and Stress Scale (DASS 21)
timeFrame: Within 1 week before the intervention
measure: Anxiety level as measured by participant's report on the Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Within 1 week after the intervention
measure: Depression, anxiety and stress symptomatology as measured by participant's report on the Depression, Anxiety, and Stress Scale (DASS 21)
timeFrame: Within 1 week after the intervention
measure: Anxiety level as measured by participant's report on the Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Within 1 week after the end of the 4 week post-intervention follow-up period
measure: Depression, anxiety and stress symptomatology as measured by participant's report on the Depression, Anxiety, and Stress Scale (DASS 21)
timeFrame: Within 1 week after the end of the 4 week post-intervention follow-up period
measure: Study feasibility as measured by recruitment rate
timeFrame: Within 4 weeks of ending recruitment
measure: Study feasibility as measured by eligibility rate
timeFrame: Within 4 weeks of ending recruitment
measure: Study feasibility as measured by consent rate
timeFrame: Within 4 weeks of ending recruitment
measure: Study feasibility as measured by retention rate
timeFrame: Within 4 weeks of ending data collection
measure: Study feasibility as measured by pre-intervention data collection rate
timeFrame: Within 4 weeks of ending data collection
measure: Study feasibility as measured by pre-intervention data collection completeness
timeFrame: Within 4 weeks of ending data collection
measure: Study feasibility as measured by post-intervention data collection rate
timeFrame: Within 4 weeks of ending data collection
measure: Study feasibility as measured by post-intervention data collection completeness
timeFrame: Within 4 weeks of ending data collection
measure: Study feasibility as measured by 4 week post intervention follow-up data collection rate
timeFrame: Within 4 weeks of ending data collection
measure: Study feasibility as measured by 4 week post intervention follow-up data collection completeness
timeFrame: Within 4 weeks of ending data collection
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: City, University of London
state: Greater London
city: London
country: United Kingdom
facility: City University of London
Study officials:
affiliation: City, University of London
name: Miriam T Ashford, MS, cand.PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: City, University of London
name: Susan Ayers, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.