Web Based Patient Tutorial on Prolonged Grief (STTR2)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05575817 |
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Recruitment Status :
Recruiting
First Posted : October 12, 2022
Last Update Posted : October 12, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prolonged Grief Disorder | Behavioral: Web Based Patient Tutorial on Prolonged Grief Disorder Therapy | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention 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) |
| Primary Purpose: | Other |
| Official Title: | Web Based Therapist and Patient Tutorials on Prolonged Grief. Study 2 |
| Actual Study Start Date : | October 1, 2022 |
| Estimated Primary Completion Date : | May 30, 2023 |
| Estimated Study Completion Date : | June 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
- Patient feedback survey [ Time Frame: Up to 6 months (treatment completion) ]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.
- Therapist feedback survey [ Time Frame: Up to 6 months (treatment completion) ]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.
- Inventory of Complicated Grief [ Time Frame: Change from baseline to 6 months (before and after treatment completion) ]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).
- Work and Social Adjustment Scale [ Time Frame: Change from baseline to 6 months (before and after treatment completion) ]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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Licensed mental health professionals trained in prolonged grief disorder treatment and their clients in treatment for prolonged grief
Exclusion Criteria:
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05575817
| Contact: Natalia Skritskaya, PhD | 212-851-2325 | ns2712@columbia.edu | |
| Contact: Gaelle Bottex, MSW | 212-851-2107 | gb2620@columbia.edu |
| United States, New York | |
| Center for Complicated Grief, Columbia School of Social Work | Recruiting |
| New York, New York, United States, 10027 | |
| Contact: Natalia A. Skritskaya, PhD 212-851-2325 ns2712@columbia.edu | |
| Principal Investigator: Katherine Shear, MD | |
| United States, Wisconsin | |
| Center for Psychological Consultation | Recruiting |
| Madison, Wisconsin, United States, 53717 | |
| Contact: Kenneth A. Kobak, PhD 608-406-2621 kobak@charter.net | |
| Principal Investigator: | Kenneth A Kobak, PhD | Center for Psychological Consulation | |
| Principal Investigator: | Katerine Shear, MD | Columbia School of Social Work |
| Responsible Party: | Katherine Shear, MD, Marion E. Kenworthy Professor of Psychiatry, Columbia University |
| ClinicalTrials.gov Identifier: | NCT05575817 |
| Other Study ID Numbers: |
AAAT7389 Study2 1R41MH118126-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 12, 2022 Key Record Dates |
| Last Update Posted: | October 12, 2022 |
| Last Verified: | October 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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grief therapy training |