Prolonged Grief DisorderNCT05121792
Web Based Therapist Tutorial on Prolonged Grief
A study testing Web Based Therapist Tutorial on Prolonged Grief Disorder Therapy in people with Prolonged Grief Disorder, run by Columbia University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Grief Disorder
- What is being tested?
- Web Based Therapist Tutorial on Prolonged Grief Disorder Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Oct 2021to 15 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mental health professional
Who cannot join
- Student or employee of Columbia University
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Psychological Consultation
Madison, Wisconsin, 53717
Center for Complicated Grief, Columbia School of Social Work
New York, New York, 10027
About this study
Official title: Web Based Therapist and Patient Tutorials on Prolonged Grief. Study 1
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.
Read the 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.
- Conditions
- Prolonged Grief Disorder
- Being tested
- Web Based Therapist Tutorial on Prolonged Grief Disorder Therapy
- Keywords
- grief, therapy, training
- Medical subject headings
- Prolonged Grief Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web Based Therapist Tutorial on Prolonged Grief Disorder TherapyBehavioural
The tutorial consists of 10 online modules following the main procedures of the Prolonged Grief Disorder Therapy (formerly known as Complicated Grief Treatment). Each module includes didactic information and interactive activities and videos, and takes approximately 30 minutes to review. Participants can study the material at their own pace.
| Study group | Role | What they receive |
|---|---|---|
| Therapist online training in Prolonged Grief Disorder Therapy | Experimental | Participants will be given access to an online 10-module interactive tutorial about Prolonged Grief Disorder Therapy. Receives: Behavioral: Web Based Therapist Tutorial on Prolonged Grief Disorder Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
User Satisfaction Questionnaire (USQ)
The USQ evaluates participant satisfaction with the clinical content of web-based applications, and how effective the participant felt the learning was. The USQ contains 15 statements, each rated on a 4-point scale (strongly agree, agree, disagree, strongly disagree), and covers several dimensions of the user experience. It also solicits open-ended feedback. The scale ranges from 15 to 60, with a higher score indicating user satisfaction. The investigators will consider an overall mean score of 45 (i.e., an average score of 3 ["agree" on all items]) to demonstrate acceptable user satisfaction with the clinical content.
Measured: Week 5 (after training completion)
System Usability Scale (SUS)
The SUS is a 10-item self-report scale designed to evaluate the usability and user satisfaction with web-based and other technologies. It obtains quantitative feedback on a 0-100 scale regarding the effectiveness, efficiency, and satisfaction users experience while interacting with engineered systems. A mean SUS score significantly greater than 50.9 (mean rating for systems considered "Okay") would be evidence of system user-friendliness; "Good" is considered a mean rating of 71.4 or better.
Measured: Week 5 (after training completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start28 Oct 2021
- Primary completion1 Apr 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prolonged Grief DisorderStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Psychological Consultation, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Katherine Shear, MD, Columbia University
- Investigators
- Kenneth A. Kobak, PhD, Principal investigator, Center for Psychological Consultation, WIKatherine Shear, MD, Principal investigator, Columbia School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121792
- Sponsor's protocol ID
- AAAT7389 Study1
- Other IDs
- 1R41MH118126-01A1
- Status last verified
- Jul 2022
- First submitted
- 5 Nov 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15928281Shear 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.
PubMed 27276373Kobak K, Shear MK, Skritskaya NA, Bloom C, Bottex G. A Web-Based Therapist Training Tutorial on Prolonged Grief Disorder Therapy: Pre-Post Assessment Study. JMIR Med Educ. 2023 Mar 27;9:e44246. doi: 10.2196/44246.
PubMed 36972105
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web Based Therapist and Patient Tutorials on Prolonged Grief. Study 1
- ClinicalTrials.gov ID
- NCT05121792
- Acronym / sponsor ID
- AAAT7389 Study1
- Conditions
- Prolonged Grief Disorder
- Keywords
- grief, therapy, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Center for Psychological Consultation, National Institute of Mental Health (NIMH)
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Therapist online training in Prolonged Grief Disorder Therapy | Experimental | Behavioral: Web Based Therapist Tutorial on Prolonged Grief Disorder TherapyParticipants will be given access to an online 10-module interactive tutorial about Prolonged Grief Disorder Therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mental health professional
Key exclusion criteria (1 listed)
- Student or employee of Columbia University
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web Based Therapist Tutorial on Prolonged Grief Disorder TherapyThe tutorial consists of 10 online modules following the main procedures of the Prolonged Grief Disorder Therapy (formerly known as Complicated Grief Treatment). Each module includes didactic information and interactive activities and videos, and takes approximately 30 minutes to review. Participants can study the material at their own pace. | Behavioural | Therapist online training in Prolonged Grief Disorder Therapy |
Primary outcome
User Satisfaction Questionnaire (USQ)
Time frame: Week 5 (after training completion)
The USQ evaluates participant satisfaction with the clinical content of web-based applications, and how effective the participant felt the learning was. The USQ contains 15 statements, each rated on a 4-point scale (strongly agree, agree, disagree, strongly disagree), and covers several dimensions of the user experience. It also solicits open-ended feedback. The scale ranges from 15 to 60, with a higher score indicating user satisfaction. The investigators will consider an overall mean score of 45 (i.e., an average score of 3 ["agree" on all items]) to demonstrate acceptable user satisfaction with the clinical content.
System Usability Scale (SUS)
Time frame: Week 5 (after training completion)
The SUS is a 10-item self-report scale designed to evaluate the usability and user satisfaction with web-based and other technologies. It obtains quantitative feedback on a 0-100 scale regarding the effectiveness, efficiency, and satisfaction users experience while interacting with engineered systems. A mean SUS score significantly greater than 50.9 (mean rating for systems considered "Okay") would be evidence of system user-friendliness; "Good" is considered a mean rating of 71.4 or better.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 15928281Shear 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.
- Background: PubMed 27276373Shear 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.
- Derived from this study: PubMed 36972105Kobak K, Shear MK, Skritskaya NA, Bloom C, Bottex G. A Web-Based Therapist Training Tutorial on Prolonged Grief Disorder Therapy: Pre-Post Assessment Study. JMIR Med Educ. 2023 Mar 27;9:e44246. doi: 10.2196/44246.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth A. Kobak, PhD principal investigator
Center for Psychological Consultation, WI
Katherine Shear, MD principal investigator
Columbia School of Social Work
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web Based Therapist Tutorial on Prolonged Grief Disorder Therapy in people with Prolonged Grief Disorder, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User Satisfaction Questionnaire (USQ) (time frame: Week 5 (after training completion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05121792, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.