Clinical trial NCT05575817: Web Based Patient Tutorial on Prolonged Grief
Official title: Web Based Therapist and Patient Tutorials on Prolonged Grief. Study 2
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: 2022-10-12
Enrollment: 34
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 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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient feedback survey
timeFrame: Up to 6 months (treatment completion)
measure: Therapist feedback survey
timeFrame: Up to 6 months (treatment completion)
Secondary outcomes:
measure: Inventory of Complicated Grief
timeFrame: Change from baseline to 6 months (before and after treatment completion)
measure: Work and Social Adjustment Scale
timeFrame: Change from baseline to 6 months (before and after treatment completion)
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 Consulation
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.