NCT05121792

Brief Summary

Death of a loved one is a difficult life experience. About 1 in 10 bereaved people are strongly affected by the loss and grieve intensely for a long time. As a result of the COVID-19 pandemic, more people may struggle with grief. The investigators have developed and tested a talk therapy for prolonged grief. The investigators have developed an online grief training for clinicians. The investigators will test if clinicians benefit from the online training and if they find it helpful and engaging. The investigators will recruit 30 mental health professionals as trainees to undergo the training. The mental health professionals will complete questionnaires before and after training to determine how much they learned and how much they liked the training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

November 5, 2021

Last Update Submit

July 19, 2022

Conditions

Keywords

grieftherapytraining

Outcome Measures

Primary Outcomes (2)

  • User Satisfaction Questionnaire (USQ)

    The USQ evaluates participant satisfaction with the clinical content of web-based applications, and how effective the participant felt the learning was. The USQ contains 15 statements, each rated on a 4-point scale (strongly agree, agree, disagree, strongly disagree), and covers several dimensions of the user experience. It also solicits open-ended feedback. The scale ranges from 15 to 60, with a higher score indicating user satisfaction. The investigators will consider an overall mean score of 45 (i.e., an average score of 3 \["agree" on all items\]) to demonstrate acceptable user satisfaction with the clinical content.

    Week 5 (after training completion)

  • System Usability Scale (SUS)

    The SUS is a 10-item self-report scale designed to evaluate the usability and user satisfaction with web-based and other technologies. It obtains quantitative feedback on a 0-100 scale regarding the effectiveness, efficiency, and satisfaction users experience while interacting with engineered systems. A mean SUS score significantly greater than 50.9 (mean rating for systems considered "Okay") would be evidence of system user-friendliness; "Good" is considered a mean rating of 71.4 or better.

    Week 5 (after training completion)

Study Arms (1)

Therapist online training in Prolonged Grief Disorder Therapy

EXPERIMENTAL

Participants will be given access to an online 10-module interactive tutorial about Prolonged Grief Disorder Therapy.

Behavioral: Web Based Therapist Tutorial on Prolonged Grief Disorder Therapy

Interventions

The tutorial consists of 10 online modules following the main procedures of the Prolonged Grief Disorder Therapy (formerly known as Complicated Grief Treatment). Each module includes didactic information and interactive activities and videos, and takes approximately 30 minutes to review. Participants can study the material at their own pace.

Therapist online training in Prolonged Grief Disorder Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mental health professional

You may not qualify if:

  • Student or employee of Columbia University

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Complicated Grief, Columbia School of Social Work

New York, New York, 10027, United States

Location

Center for Psychological Consultation

Madison, Wisconsin, 53717, United States

Location

Related Publications (3)

  • Shear K, Frank E, Houck PR, Reynolds CF 3rd. Treatment of complicated grief: a randomized controlled trial. JAMA. 2005 Jun 1;293(21):2601-8. doi: 10.1001/jama.293.21.2601.

    PMID: 15928281BACKGROUND
  • Shear MK, Reynolds CF 3rd, Simon NM, Zisook S, Wang Y, Mauro C, Duan N, Lebowitz B, Skritskaya N. Optimizing Treatment of Complicated Grief: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jul 1;73(7):685-94. doi: 10.1001/jamapsychiatry.2016.0892.

    PMID: 27276373BACKGROUND
  • Kobak K, Shear MK, Skritskaya NA, Bloom C, Bottex G. A Web-Based Therapist Training Tutorial on Prolonged Grief Disorder Therapy: Pre-Post Assessment Study. JMIR Med Educ. 2023 Mar 27;9:e44246. doi: 10.2196/44246.

MeSH Terms

Conditions

Prolonged Grief Disorder

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Study Officials

  • Kenneth A. Kobak, PhD

    Center for Psychological Consultation, WI

    PRINCIPAL INVESTIGATOR
  • Katherine Shear, MD

    Columbia School of Social Work

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Study 1 is an open-label (non-randomized) study to generate pilot data on effectiveness, and to evaluate feasibility and acceptability of the therapist online training program.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Marion E. Kenworthy Professor of Psychiatry

Study Record Dates

First Submitted

November 5, 2021

First Posted

November 16, 2021

Study Start

October 28, 2021

Primary Completion

April 1, 2022

Study Completion

June 15, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations