NCT03484338

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2020

Enrollment Period

1.4 years

First QC Date

March 8, 2018

Last Update Submit

December 3, 2020

Conditions

GriefDepressive SymptomsTrauma, Psychological

Outcome Measures

Primary Outcomes (3)

  • 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.

    4 weeks, follow up at 12 weeks

  • 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.

    4 weeks, follow up at 12 weeks

  • 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.

    4 weeks, follow up at 12 weeks

Secondary Outcomes (1)

  • change in stress response

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

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Accelerated Resolution Therapy

Wait list controlled

ACTIVE COMPARATOR
Behavioral: Accelerated Resolution Therapy

Interventions

Accelerated Resolution TherapyBEHAVIORAL

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

InterventionWait list controlled

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 DSM-5 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harleah Buck

Tampa, Florida, 33612, United States

Location

Related Publications (1)

  • Buck HG, Benitez B, Mason T, Hernandez D, Tofthagen C, Mogle J. Exploring the role of expectancy in older US participants' response to an accelerated resolution therapy intervention for prolonged grief disorder. Health Soc Care Community. 2022 Nov;30(6):e4191-e4198. doi: 10.1111/hsc.13813. Epub 2022 Apr 9.

    PMID: 35396879DERIVED

MeSH Terms

Conditions

DepressionPsychological Trauma

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Harleah Buck, PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 30, 2018

Study Start

February 20, 2018

Primary Completion

July 31, 2019

Study Completion

October 30, 2019

Last Updated

December 7, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)