ClinicalTrials.gg
CompletedNCT03484338Updated Dec 7, 2020

Accelerated Resolution Therapy for Complicated Grief

An interventional study of Accelerated Resolution Therapy in Grief, Depressive Symptoms and Trauma, Psychological, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2020-12-07.

Sponsored by University of South Florida · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 14 studies in Depression by University of South Florida — 4 open to participants now, 4 under way, none of them phase 3. Depression · University of South Florida.

Enrollment
6th of 13
54 · median 48
Started
2018
with 1 other
No phase
13 of 14
4 open now
Registered
4th of 14
by date

Among the 14 studies in Depression by University of South Florida, this one is the 6th largest by enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2018, is one of 13 with no phase, and was the 4th registered.

Depression

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

Browse Depression studies →

Open to participants now

4 of the 14 studies in Depression by University of South Florida are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.

This study: 60 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 14 studies in Depression by University of South Florida, or all of them as a file.
02

Study summary

This study will examine whether accelerated resolution therapy (ART) is effective for the treatment of prolonged and complicated grief and associated psychological trauma among older adult hospice caregivers who have experienced the death of an immediate family member at least 12 months ago.

Read the detailed description

ART is an evidence-based therapy for the treatment of depressive symptoms and trauma and stress-related disorders that includes the core components of trauma-focused therapy including imaging rescripting, voluntary image replacement, guided visualization with use of eye movements, desensitization and processing of distressing memories, and in-vitro exposure to future feared triggers. Mental health professionals are delivering ART in clinical practice to assist with grief; however, there is a need for formal research evaluation of the effects of ART on complicated grief and psychological distress.

03

Conditions studied

  • Grief
  • Depressive Symptoms
  • Trauma, Psychological
04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult age 60 years of age or older
  • previous primary caregiver of immediate family member who died after enrollment in hospice with the death occurring at least 12 months prior to enrollment
  • current symptoms indicative of proposed diagnostic criteria for complicated grief disorder, as proposed by Shear et al. (2011)
  • current score of >25 on the 19-item Inventory of Complicated Grief
  • current symptoms indicative of significant psychological trauma, as documented by score >33on the 20-item PTSD checklist (PCL-5)26 or score >4 on the PDSQ PTSD subscale
  • denial of suicidal ideation or intent, with no evidence of psychotic behavior

Exclusion criteria

Exclusion Criteria:

  • engaged in another psychotherapy regimen that could also influence symptoms of PCG - - major psychiatric disorder (e.g. bipolar disorder) deemed likely to interfere with treatment delivery
  • current substance abuse dependence (alcohol and/or drug) treatment anticipated to interfere with treatment delivery.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Intervention

    Behavioral: Accelerated Resolution Therapy

  • Active comparator
    Wait list controlled

    Behavioral: Accelerated Resolution Therapy

Interventions

  • BehavioralAccelerated Resolution Therapy

    ART is an evidence-based therapy for the treatment of depressive symptoms and trauma and stress-related disorders that includes the core components of trauma-focused therapy including imaging rescripting, voluntary image replacement, guided visualization with use of eye movements, desensitization and processing of distressing memories, and in-vitro exposure to future feared triggers

06

What researchers measure

Primary outcomes

  1. change in complicated grief symptoms

    Response on the 19-item Inventory of Complicated Grief (ICF) over the course of the 4-week intervention period. Scores range from 0-76 with a score \>24 indicating presence of complicated grief.

    Time frame: 4 weeks, follow up at 12 weeks

  2. change in psychological trauma

    The PCL-5 (PTSD Patient Checklist)26 is a 20-item self-report instrument that will be used to assess the DSM-5 symptoms of PTSD (psychological trauma)(corresponding to criteria B-E). The total symptom severity score ranges from 0 to . A diagnostic cut-point for PTSD of 33 has been recommended. In addition, it is generally accepted that a reduction of 10 points or more on the PCL-5 is indicative of statistical and clinically meaningful improvement.

    Time frame: 4 weeks, follow up at 12 weeks

  3. change in depressive symptoms

    The Center for Epidemiologic Studies Depression Scale(CES-D)37is a widely used 20-item scale that has proven useful both as a screening instrument to detect individuals at risk for depression, and to measure the symptoms of depression.

    Time frame: 4 weeks, follow up at 12 weeks

Secondary outcomes

  1. change in stress response

    For the biomarkers of sAA and IL-6, measurement will occur using the protocols listed in the Salimetrics® α-Amylase Kinetic Enzyme Assay Kit for kinetic measurement of sAA activity (Appendix B) and Salimetrics® Salivary Interleukin-6 Elisa Kit KIT (Appendix C). The unstimulated passive drool method will be used. Participants will be asked to tilt head forward, allowing the saliva to pool on the floor of the mouth, and then pass the saliva through the SalivaBio Collection Aid (SCA) into a polypropylene vial.

    Time frame: weekly pre to post ART and over the 4 week intervention period

07

Study locations

1 site
  • Harleah Buck
    Tampa, Florida 33612, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Jul 2019, 17 months.

Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 17 months is below that.

Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2018
First posted
Mar 30, 2018
StartActual
Feb 20, 2018
Primary completionActual
Jul 31, 2019
CompletionActual
Oct 30, 2019
Last update
Dec 7, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03484338
Responsible party
Kevin Kip (Distinguished Professor, University of South Florida) — Principal investigator
First posted
Mar 30, 2018
Start date
Feb 20, 2018
Primary completion
Jul 31, 2019
Completion
Oct 30, 2019
Last update
Dec 7, 2020

Study contacts

Harleah Buck, PhD
principal investigator · University of South Florida

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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