Web Based Patient Tutorial on Prolonged Grief (STTR2)

Web Based Therapist and Patient Tutorials on Prolonged Grief. Study 2

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.

Study Overview

• Status: Completed
• Conditions: Prolonged Grief Disorder
• Intervention / Treatment: Behavioral: Web Based Patient Tutorial on Prolonged Grief Disorder Therapy

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • Center for Complicated Grief, Columbia School of Social Work
  • Wisconsin
    • Madison, Wisconsin, United States, 53717
      • Center for Psychological Consultation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Licensed mental health professionals trained in prolonged grief disorder treatment and their clients in treatment for prolonged grief.

Inclusion criteria to participate in step 2 of the study are:

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

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patient online grief tutorial; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inventory of Complicated Grief	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).	Change from baseline to 6 months (before and after treatment completion)
Work and Social Adjustment Scale	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).	Change from baseline to 6 months (before and after treatment completion)

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Mental Health (NIMH); Center for Psychological Consultation
• Investigators: Principal Investigator: Kenneth A Kobak, PhD, Center for Psychological Consulation; Principal Investigator: Katherine Shear, MD, Columbia School of Social Work

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: training; therapy; grief
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Prolonged Grief Disorder
• Other Study ID Numbers: AAAT7389 Study2; 1R41MH118126-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No