Study Results
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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COMPLETED
NA
34 participants
INTERVENTIONAL
2022-10-01
2024-01-31
Brief Summary
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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.
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
OTHER
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.
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.
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.
Eligibility Criteria
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Inclusion 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
18 Years
ALL
No
Sponsors
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Center for Psychological Consultation
OTHER
National Institute of Mental Health (NIMH)
NIH
Columbia University
OTHER
Responsible Party
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Katherine Shear, MD
Marion E. Kenworthy Professor of Psychiatry
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
Center for Psychological Consultation
Madison, Wisconsin, United States
Countries
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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.
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.
Other Identifiers
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AAAT7389 Study2
Identifier Type: -
Identifier Source: org_study_id
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