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Web Based Therapist Tutorial on Prolonged Grief

Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT05121792
Collaborator
Center for Psychological Consultation (Other), National Institute of Mental Health (NIMH) (NIH)
400
Enrollment
2
Locations
1
Arm
7.6
Actual Duration (Months)
200
Patients Per Site
26.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Web Based Therapist Tutorial on Prolonged Grief Disorder Therapy
 N/A

Detailed Description

The investigators developed a short-term, manualized Prolonged Grief Disorder Therapy (PGDT), originally known as Complicated Grief Treatment and found it efficacious in three large National Institute of Mental Health (NIMH) sponsored randomized controlled trials. Facilitating access to training in Empirically Based Treatments has been identified as a national priority by both mental health professional organizations and NIMH. One way to help disseminate therapist training on EBT of Prolonged Grief Disorder (PGD) is through the use of new technologies. The investigators recently developed an online therapist training program in PGDT and a patient facing therapist-assisted web-based form of PGDT. The investigators are now looking to evaluate the acceptability and effectiveness of each of these online tools in pilot studies.

The tutorial contains 10 modules, each about 20-40 minutes long with information needed for effective delivery of PGDT. Participants will be encouraged to space out the tutorial vs. taking it in a few long sessions, to facilitate knowledge retention. A post-test will be given immediately after completing each module, as testing done closer to when the material was learned also improves retention. Participants will be encouraged to complete the tutorial within 5 weeks (about one hour or two modules per week). Consistent with continuing education guidelines, successful completion will require an overall score of 80% on post-tests. Participants would need to retake the module until a passing score is obtained. Interactive Patient Scenarios will be integrated into the tutorial at strategic points, in order to integrate conceptual and applied knowledge. All participants will be asked to evaluate whether the stated learning goals of each module were met and complete user satisfaction questionnaires on both the technical aspects of the on-line tutorial (using the System Usability Scale), and the clinical content (using the User Satisfaction Questionnaire). Participants will have access to the tutorial indefinitely, in order to provide a resource that they can refer back to as they begin to use these skills with patients.

Study Design

Study Type:
Interventional
Actual Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Web Based Therapist and Patient Tutorials on Prolonged Grief. Study 1
Actual Study Start Date :
Oct 28, 2021
Actual Primary Completion Date :
Apr 1, 2022
Actual Study Completion Date :
Jun 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Therapist online training in Prolonged Grief Disorder Therapy

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
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.

Outcome Measures

Primary Outcome Measures

  1. User Satisfaction Questionnaire (USQ) [Week 5 (after training completion)]

    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.

  2. System Usability Scale (SUS) [Week 5 (after training completion)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Mental health professional
Exclusion Criteria:
  • Student or employee of Columbia University

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Complicated Grief, Columbia School of Social Work New York New York United States 10027
2 Center for Psychological Consultation Madison Wisconsin United States 53717

Sponsors and Collaborators

  • Columbia University
  • Center for Psychological Consultation
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Kenneth A. Kobak, PhD, Center for Psychological Consultation, WI
  • Principal Investigator: Katherine Shear, MD, Columbia School of Social Work

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Katherine Shear, MD, Marion E. Kenworthy Professor of Psychiatry, Columbia University
ClinicalTrials.gov Identifier:
NCT05121792
Other Study ID Numbers:
  • AAAT7389 Study1
  • 1R41MH118126-01A1
First Posted:
Nov 16, 2021
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Katherine Shear, MD, Marion E. Kenworthy Professor of Psychiatry, Columbia University
grief
therapy
training

Study Results

No Results Posted as of Jul 20, 2022