Web Based Patient Tutorial on Prolonged Grief

NCT05575817 | Completed

• 2 other identifiers: AAAT7389 Study21R41MH118126-01A1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Prolonged Grief Disorder

Keywords

grief; therapy; training

Outcome Measures

Primary Outcomes (2)

• Patient feedback survey

  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.

  Up to 6 months (treatment completion)

• Therapist feedback survey

  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.

  Up to 6 months (treatment completion)

Secondary Outcomes (2)

• Inventory of Complicated Grief

  Change from baseline to 6 months (before and after treatment completion)

• Work and Social Adjustment Scale

  Change from baseline to 6 months (before and after treatment completion)

Study Arms (1)

Patient online grief tutorial

EXPERIMENTAL

Participants will be given access to an online 9-module interactive tutorial about grief to be used in conjunction with a course of Prolonged Grief Disorder Therapy.

Behavioral: Web Based Patient Tutorial on Prolonged Grief Disorder Therapy

Interventions

Web Based Patient Tutorial on Prolonged Grief Disorder Therapy BEHAVIORAL

The patient tutorial will contain 9 modules, each designed to be used flexibly in conjunction with Prolonged Grief Disorder Therapy (PGDT) telehealth sessions with the therapist. Each module takes about 15-30 minutes to complete. The patient tutorial consists of information about grief and adaptation to loss, including a description of seven healing milestones that are the focus of PGDT and an explanation of prolonged grief and how to understand it. In addition, the tutorial has descriptions of the procedure, goals and rationale for a series of in-session therapeutic exercises to be undertaken with the therapist, as well as descriptions and encouragement to participate in interim therapeutic activities (i.e., "homework") assigned by the therapist after each treatment session. The tutorial also contains a self-assessment component for each module that can be completed by the patient and shared with the therapist.

Patient online grief tutorial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a clinical diagnosis of prolonged grief disorder according to DSM-5 criteria,
• a judgment that grief is the primary problem,
• a score of at least 30 on the Inventory for Complicated Grief (ICG), and
• at least 1 year has passed after the death of their loved one (part of DSM-5 criteria).

You may not qualify if:

• \) active suicidal ideation or suicidal intent, current or past psychotic disorder, or active substance use disorder.

Sponsors & Collaborators

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

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 (2)

• 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: 15928281 BACKGROUND

• 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: 27276373 BACKGROUND

MeSH Terms

Conditions

Prolonged Grief Disorder

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Kenneth A Kobak, PhD

  Center for Psychological Consulation

  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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marion E. Kenworthy Professor of Psychiatry

Model Details: Study 2 is an open-label (non-randomized) pilot study to determine therapist and patient acceptance, feasibility and whether there is enough of a signal in improving clinical outcomes to warrant a randomized trial of the online patient grief tutorial in conjunction with Prolonged Grief Disorder therapy.

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: October 1, 2022
• Primary Completion: June 15, 2023
• Study Completion: January 31, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)