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

NCT02434406 | Completed

• 1 other identifier: PhD/14-15/16
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (16)

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

  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)

  Within 1 week before the intervention

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

  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)

  Within 1 week after the intervention

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

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

Study Arms (2)

Web-based intervention

EXPERIMENTAL

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

Wait-list control

NO INTERVENTION

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

Interventions

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.

Web-based intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• City, University of London: lead
• Monash University: collaborator

Study Sites (2)

City, University of London

London, Greater London, EC1V 0HB, United Kingdom

Location

City University of London

London, United Kingdom

Location

Related Publications (2)

• 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

  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.

  PMID: 29678804 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Psychological Well-Being; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Miriam T Ashford, MS, cand.PhD

  City, University of London

  PRINCIPAL INVESTIGATOR

• Susan Ayers, Professor

  City, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 5, 2015
• Study Start: March 26, 2017
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: January 31, 2018

Record last verified: 2018-01

Locations

GB (2)