Web Based Patient Tutorial on Prolonged Grief

Prolonged Grief Disorder Clinical Trial

— STTR2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05575817
• Other study ID #: AAAT7389 Study2
• Secondary ID: 1R41MH118126-01A
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: April 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 31, 2024
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prolonged Grief Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Psychological Consultation	Madison	Wisconsin
United States	Center for Complicated Grief, Columbia School of Social Work	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Center for Psychological Consultation, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)