Web Based Patient Tutorial on Prolonged Grief

Not Applicable

Completed

• Conditions: Prolonged Grief Disorder

• Registration Number: NCT05575817
• Lead Sponsor: Columbia University

Brief Summary

The goal of this clinical trial is to learn about usefulness of the online patient grief tutorial in bereaved adults with Prolonged Grief Disorder who are receiving psychotherapy treatment for it. The main question it aims to answer is how helpful the tutorial was and how much therapists and clients liked it.

Participants will be given access to the online tutorial for use during their talk therapy treatment. Participants will be asked to complete surveys before starting the treatment and after its completion to provide information about their symptoms and feedback about the tutorial.

Detailed Description

The Center for Prolonged Grief at Columbia University will send announcements to therapists who have done training in Prolonged Grief Disorder Treatment (PGDT) inviting them to participate in the study and directing them to a study information page in Qualtrics. After reviewing the information sheet, therapists will give their consent for participation and then complete a demographics and professional experience questionnaire. The study coordinator will monitor Qualtrics for new responses and email eligible therapist-participants instructions for accessing the tutorial in Moodle.

Participating therapists will then recruit their patients to take part in the study and direct them to the study information page in Qualtrics to provide consent. Therapists will conduct a clinical assessment to determine that the client is an appropriate candidate for the study. Then therapists will provide the clients with a brief introduction to the patient tutorial and log-in credentials, before starting Prolonged Grief Disorder Treatment. Client-participants will have access to the tutorial for 6 months.

The patient tutorial will supplement a course of Prolonged Grief Disorder Treatment (aka Complicated Grief Treatment or CGT) provided by participating therapists in their practices. Typical course of PGDT takes about 4 months of weekly meetings. Therapists are licensed professionals who will monitor their patients, as usual in practice, and can recommend to stop the study treatment at any point or switch to alternative treatment, as indicated. Frequency, duration and pattern of use of the patient online tutorial will be monitored. Patients will also complete online questionnaires about their grief symptoms before and after treatment and overall experience with the tutorial.

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-12
• Primary Completion: 2023-06-15
• Study Completion: 2024-01-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient feedback survey	Up to 6 months (treatment completion)	This is a 7-item questionnaire about usefulness of the tutorial; 4 items are rated from 1 (strongly disagree) to 5 (strongly agree) and are added for a composite total score (range 4-20) with higher scores indicating greater usefulness (better outcome). 3 remaining items solicit open-ended written feedback.
Therapist feedback survey	Up to 6 months (treatment completion)	This is a 6-item questionnaire about usefulness of the tutorial where 3 items are rated from 1 (strongly disagree) to 5 (strongly agree)and are added for a composite total score (range 3-15) with higher scores indicating greater usefulness (better outcome). 3 remaining items solicit open-ended written feedback.

Secondary Outcome Measures

Name	Time	Method
Inventory of Complicated Grief	Change from baseline to 6 months (before and after treatment completion)	This is a 19-item questionnaire assessing prolonged grief symptoms. Each item is rated on a scale 0-4 to produce a total score ranges from 0 to 76, with higher scores indicating more severe grief (worse outcome).
Work and Social Adjustment Scale	Change from baseline to 6 months (before and after treatment completion)	This is a self-report scale assessing grief interference in 5 areas of functioning, rated 0-8, with a total score ranging from 0 to 40 with higher scores indicating more interference (worse outcome).

Trial Locations

Locations (2)

Center for Complicated Grief, Columbia School of Social Work; 🇺🇸 New York, New York, United States

Center for Psychological Consultation; 🇺🇸 Madison, Wisconsin, United States