Web Based Patient Tutorial on Prolonged Grief

NCT ID: NCT05575817

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-01-31

Brief Summary

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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

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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.

Conditions

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Prolonged Grief Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Web Based Patient Tutorial on Prolonged Grief Disorder Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Center for Psychological Consultation

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Katherine Shear, MD

Marion E. Kenworthy Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth A Kobak, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Psychological Consulation

Katherine Shear, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia School of Social Work

Locations

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Center for Complicated Grief, Columbia School of Social Work

New York, New York, United States

Site Status

Center for Psychological Consultation

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15928281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27276373 (View on PubMed)

Other Identifiers

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1R41MH118126-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAT7389 Study2

Identifier Type: -

Identifier Source: org_study_id

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