The Feasibility, Usability and Satisfaction of an Online Tool for Perinatal Mental Health Problems

NCT06035159 | Completed

• 1 other identifier: ONZ-2022-0386
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

With this study the investigators aim to examine through a mixed method study the feasibility, usability and satisfaction with the developed online tool for perinatal mental health problems. This will be done through a pre- and post measurement of depressive and anxiety symptoms and the use of the tool itself. In addition, a qualitative thematic analysis will be conducted on the clarity, understandability and user-friendliness of the tool.

Conditions

Depression; Depressive Disorder, Major; Depression, Postpartum; Anxiety; Anxiety Disorders; Pregnancy Related

Keywords

software, psychotherapy, telemedicine

Outcome Measures

Primary Outcomes (12)

• use of the online tool, by means of time logged in

  time spent logged in (minutes)

  up to 10 weeks

• use of the online tool, by means of number of log-ins

  number of log-ins (number)

  up to 10 weeks

• use of the online tool, by means of number of lesson/modules started

  number of modules started (number)

  up to 10 weeks

• use of the online tool, by means of number of exercises completed

  number of exercises completed (number)

  up to 10 weeks

• usability of the online tool, by means of the System Usability Scale (SUS), when participant completes the program

  the system usability scale, the SUS, total score

  through study completion, after each module (up to 10 wks)

• usability of the online tool, by means of the System Usability Scale (SUS) when participant no longer logs in and after invitation through email reminder

  the system usability scale, the SUS, total socre

  2 weeks

• usability of the online tool, by means of an open-ended qualitative question when participant completes the program.

  a qualitative open question

  through study completion, after each module (up to 10 wks)

• usability of the online tool, by means of an open-ended qualitative question, when participant no longer logs in and after invitation through email reminder

  a qualitative open question

  2 weeks

• patient satisfaction, by means of qualitative questions when participant completes the program

  qualitative questions (Likert scale)

  through study completion, after each module (up to 10 wks)

• patient satisfaction, by means of open-ended qualitative questions, when participant completes the program

  qualitative questions (open-ended) in-depth questions

  through study completion, after each module (up to 10 wks)

• patient satisfaction, by means of qualitative questions when participant no longer logs in, and after invitation through email reminder

  qualitative questions (Likert scale)

  2 weeks

• patient satisfaction, by means of open-ended qualitative questions when participant no longer logs in and after invitation through email reminder

  qualitative questions (open-ended) in-depth questions.

  2 weeks

Secondary Outcomes (4)

• reduction of depressive, anxiety and stress symptoms as pre-measurement

  baseline

• reduction of depressive, anxiety and stress symptoms as post-measurement

  study completion (up to 10 weeks)

• reduction of depressive and anxiety symptoms as pre-measurement

  baseline

• reduction of depressive, and anxiety symptoms as post-measurement

  study completion (up to 10 weeks)

Study Arms (1)

online psychotherapy

OTHER

All participants have access to the psychotherapeutic intervention, which consists of 6 modules. Initially, we want to get information about the feasibility, comprehensibility and satisfaction of the participants with the tool. Secondly, the effectiveness of the intervention will be assessed through a pre-post measurement.

Behavioral: online psychotherapy

Interventions

online psychotherapy BEHAVIORAL

6 modules

online psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant or giving birth
• partner of pregnant/birthing woman
• depressive or anxiety symptoms,
• years or older,
• perinatal period (pregnancy up to 1 year after birth),
• Dutch-speaking,
• living in Belgium

You may not qualify if:

• younger than 18 years of age,
• outside perinatal period,
• do not speak Dutch well enough,
• not resident in Belgium.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• OnlinePsyHulp, Belgium: collaborator

Study Sites (1)

University Hospital of Gent

Ghent, 9000, Belgium

Location

Related Links

• online psychotherapy tool

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Depression, Postpartum; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Gilbert Lemmens, Prof

  University Hospital of Gent - University of Gent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: September 13, 2023
• Study Start: July 10, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (1)