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Accelerated Resolution Therapy for Complicated Grief

Primary Purpose

Grief, Depressive Symptoms, Trauma, Psychological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Accelerated Resolution Therapy
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Grief

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

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.

Sites / Locations

  • Harleah Buck

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Wait list controlled

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 8, 2018
Last Updated
December 3, 2020
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03484338
Brief Title
Accelerated Resolution Therapy for Complicated Grief
Official Title
Accelerated Resolution Therapy for Treatment of Complicated Grief in Senior Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Grief, Depressive Symptoms, Trauma, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Wait list controlled
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Accelerated Resolution Therapy
Intervention 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
Primary Outcome Measure Information:
Title
change in complicated grief symptoms
Description
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
Title
change in psychological trauma
Description
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
Title
change in depressive symptoms
Description
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 Outcome Measure Information:
Title
change in stress response
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harleah Buck, PhD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harleah Buck
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Accelerated Resolution Therapy for Complicated Grief

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