Anxiety DisordersNCT02434406
Website-Based Self-Help for Women With Anxiety After Childbirth
A study testing internet-What Am I Worried About in people with Anxiety Disorders, run by City, University of London at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- internet-What Am I Worried About
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 26 Mar 2017to 30 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Still birth or perinatal death of latest baby
- Latest baby seriously ill
- Report self-harm or suicidal ideation
- Currently receiving formal psychotherapy
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
City, University of London
London, Greater London, EC1V 0HB
City University of London
London
About this study
Official title: Feasibility of a Web-Based Intervention for Women With Postpartum Anxiety: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- internet-What Am I Worried About
- Keywords
- Anxiety, Anxiety disorders, Mental health, Postpartum period, maternal welfare, internet, intervention studies, feasibility studies, randomized controlled trial, patient acceptance of health care
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet-What Am I Worried AboutBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement as measured by the number of log-ins into the web-based intervention
Measured: At time of intervention (8 weeks)
Engagement as measured by the duration of log-ins into the web-based intervention
Measured: At time of intervention (8 weeks)
Engagement as measured by the total duration of time spent on the web-based intervention
Measured: At time of intervention (8 weeks)
Engagement as measured by the time spent on individual pages of the web-based intervention
Measured: At time of intervention (8 weeks)
Engagement as measured by the number of intervention coach calls
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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)
Measured: Within 2 weeks after the intervention
Usability as measured by participant's report of any technical problems experienced with the intervention website
Measured: Within 2 weeks after the intervention
Usability as measured by participant's report of interest in future usage of the intervention
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Within 2 weeks after the intervention
Women's perspectives and experiences as measured by semi-structured interviews
Measured: Within 8 weeks after the intervention
Engagement as measured by the duration of intervention coach calls
Measured: Continuous throughout the 8 week intervention period
Usability as measured by participant's report of hypothetical recommendation of the intervention to others.
Measured: 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)
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Within 1 week after the end of the 4 week post-intervention follow-up period
Study feasibility as measured by recruitment rate
Measured: Within 4 weeks of ending recruitment
Study feasibility as measured by eligibility rate
Measured: Within 4 weeks of ending recruitment
Study feasibility as measured by consent rate
Measured: Within 4 weeks of ending recruitment
Study feasibility as measured by retention rate
Measured: Within 4 weeks of ending data collection
Study feasibility as measured by pre-intervention data collection rate
Measured: Within 4 weeks of ending data collection
Study feasibility as measured by pre-intervention data collection completeness
Measured: Within 4 weeks of ending data collection
Study feasibility as measured by post-intervention data collection rate
Measured: Within 4 weeks of ending data collection
Study feasibility as measured by post-intervention data collection completeness
Measured: Within 4 weeks of ending data collection
Study feasibility as measured by 4 week post intervention follow-up data collection rate
Measured: Within 4 weeks of ending data collection
Study feasibility as measured by 4 week post intervention follow-up data collection completeness
Measured: Within 4 weeks of ending data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study start26 Mar 2017
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- City, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Sponsor
- Investigators
- Miriam T Ashford, MS, cand.PhD, Principal investigator, City, University of LondonSusan Ayers, Professor, Principal investigator, City, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434406
- Sponsor's protocol ID
- PhD/14-15/16
- Status last verified
- Jan 2018
- First submitted
- 30 Apr 2015
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
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.
PubMed 29678804
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Web-Based Intervention for Women With Postpartum Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02434406
- Acronym / sponsor ID
- PhD/14-15/16
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety, Anxiety disorders, Mental health, Postpartum period, maternal welfare, internet, intervention studies, feasibility studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- City, University of LondonUniversity, hospital or other
- Collaborators
- Monash University
- Study start
- 26 Mar 2017 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based intervention | Experimental | Behavioral: internet-What Am I Worried AboutParticipants 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. |
| Wait-list control | No intervention | –Participants get standard care and will be offered access to the web-based intervention at 8-weeks post-randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Still birth or perinatal death of latest baby
- Latest baby seriously ill
- Report self-harm or suicidal ideation
- Currently receiving formal psychotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| internet-What Am I Worried AboutThis 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. | Behavioural | Web-based intervention |
Primary outcome
Engagement as measured by the number of log-ins into the web-based intervention
Time frame: At time of intervention (8 weeks)
Engagement as measured by the duration of log-ins into the web-based intervention
Time frame: At time of intervention (8 weeks)
Engagement as measured by the total duration of time spent on the web-based intervention
Time frame: At time of intervention (8 weeks)
Engagement as measured by the time spent on individual pages of the web-based intervention
Time frame: At time of intervention (8 weeks)
Engagement as measured by the number of intervention coach calls
Time frame: 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).
Time frame: 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).
Time frame: 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)
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.
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
Usability as measured by participant's report of any technical problems experienced with the intervention website
Time frame: Within 2 weeks after the intervention
Usability as measured by participant's report of interest in future usage of the intervention
Time frame: 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).
Time frame: 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).
Time frame: Within 2 weeks after the intervention
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.
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.
Women's perspectives and experiences as measured by semi-structured interviews
Time frame: Within 8 weeks after the intervention
Engagement as measured by the duration of intervention coach calls
Time frame: Continuous throughout the 8 week intervention period
Usability as measured by participant's report of hypothetical recommendation of the intervention to others.
Time frame: Within 2 weeks after the intervention
16 secondary outcomes
Anxiety level as measured by participant's report on the Generalized Anxiety Disorder Scale (GAD-7)
Time frame: 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)
Time frame: Within 1 week before the intervention
Anxiety level as measured by participant's report on the Generalized Anxiety Disorder Scale (GAD-7)
Time frame: 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)
Time frame: Within 1 week after the intervention
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
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
Study feasibility as measured by recruitment rate
Time frame: Within 4 weeks of ending recruitment
Study feasibility as measured by eligibility rate
Time frame: Within 4 weeks of ending recruitment
Study feasibility as measured by consent rate
Time frame: Within 4 weeks of ending recruitment
Study feasibility as measured by retention rate
Time frame: Within 4 weeks of ending data collection
Study feasibility as measured by pre-intervention data collection rate
Time frame: Within 4 weeks of ending data collection
Study feasibility as measured by pre-intervention data collection completeness
Time frame: Within 4 weeks of ending data collection
Study feasibility as measured by post-intervention data collection rate
Time frame: Within 4 weeks of ending data collection
Study feasibility as measured by post-intervention data collection completeness
Time frame: Within 4 weeks of ending data collection
Study feasibility as measured by 4 week post intervention follow-up data collection rate
Time frame: Within 4 weeks of ending data collection
Study feasibility as measured by 4 week post intervention follow-up data collection completeness
Time frame: Within 4 weeks of ending data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- BackgroundRowe 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
- Derived from this study: PubMed 29678804Ashford 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.
Related trials for Anxiety Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam T Ashford, MS, cand.PhD principal investigator
City, University of London
Susan Ayers, Professor principal investigator
City, University of London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internet-What Am I Worried About in people with Anxiety Disorders, run by City, University of London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement as measured by the number of log-ins into the web-based intervention (time frame: At time of intervention (8 weeks)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02434406, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.