Clinical trial NCT05121792: Web Based Therapist Tutorial on Prolonged Grief
Official title: Web Based Therapist and Patient Tutorials on Prolonged Grief. Study 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Grief Disorder
Keywords: grief
therapy
training
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Center for Psychological Consultation
name: National Institute of Mental Health (NIMH)
First posted: 2021-11-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study 1 is an open-label (non-randomized) study to generate pilot data on effectiveness, and to evaluate feasibility and acceptability of the therapist online training program.
Primary purpose: OTHER

Brief summary: Death of a loved one is a difficult life experience. About 1 in 10 bereaved people are strongly affected by the loss and grieve intensely for a long time. As a result of the COVID-19 pandemic, more people may struggle with grief. The investigators have developed and tested a talk therapy for prolonged grief.

The investigators have developed an online grief training for clinicians. The investigators will test if clinicians benefit from the online training and if they find it helpful and engaging. The investigators will recruit 30 mental health professionals as trainees to undergo the training. The mental health professionals will complete questionnaires before and after training to determine how much they learned and how much they liked the training.

Detailed description: The investigators developed a short-term, manualized Prolonged Grief Disorder Therapy (PGDT), originally known as Complicated Grief Treatment and found it efficacious in three large National Institute of Mental Health (NIMH) sponsored randomized controlled trials. Facilitating access to training in Empirically Based Treatments has been identified as a national priority by both mental health professional organizations and NIMH. One way to help disseminate therapist training on EBT of Prolonged Grief Disorder (PGD) is through the use of new technologies. The investigators recently developed an online therapist training program in PGDT and a patient facing therapist-assisted web-based form of PGDT. The investigators are now looking to evaluate the acceptability and effectiveness of each of these online tools in pilot studies.

The tutorial contains 10 modules, each about 20-40 minutes long with information needed for effective delivery of PGDT. Participants will be encouraged to space out the tutorial vs. taking it in a few long sessions, to facilitate knowledge retention. A post-test will be given immediately after completing each module, as testing done closer to when the material was learned also improves retention. Participants will be encouraged to complete the tutorial within 5 weeks (about one hour or two modules per week). Consistent with continuing education guidelines, successful completion will require an overall score of 80% on post-tests. Participants would need to retake the module until a passing score is obtained. Interactive Patient Scenarios will be integrated into the tutorial at strategic points, in order to integrate conceptual and applied knowledge. All participants will be asked to evaluate whether the stated learning goals of each module were met and complete user satisfaction questionnaires on both the technical aspects of the on-line tutorial (using the System Usability Scale), and the clinical content (using the User Satisfaction Questionnaire). Participants will have access to the tutorial indefinitely, in order to provide a resource that they can refer back to as they begin to use these skills with patients.

Eligibility criteria: Inclusion Criteria:

* Mental health professional

Exclusion Criteria:

* Student or employee of Columbia University

Primary outcomes:
measure: User Satisfaction Questionnaire (USQ)
timeFrame: Week 5 (after training completion)
measure: System Usability Scale (SUS)
timeFrame: Week 5 (after training completion)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for Complicated Grief, Columbia School of Social Work
state: New York
city: Madison
country: United States
facility: Center for Psychological Consultation
state: Wisconsin
Study officials:
affiliation: Center for Psychological Consultation, WI
name: Kenneth A. Kobak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia School of Social Work
name: Katherine Shear, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.