Web Based Patient Tutorial on Prolonged Grief

Study Overview
=================
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.

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.

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

Conditions
-----------------
Prolonged Grief Disorder

Intervention / Treatment
-----------------
* Behavioral: Web Based Patient Tutorial on Prolonged Grief Disorder Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Licensed mental health professionals trained in prolonged grief disorder treatment and their clients in treatment for prolonged grief Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient online grief tutorial<br>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<br>* 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.<br>|

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
grief, therapy, training