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Accelerated Resolution Therapy for Complicated Grief

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ClinicalTrials.gov Identifier: NCT03484338
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Kevin Kip, University of South Florida

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.

Condition or disease Intervention/treatment Phase
Grief Depressive Symptoms Trauma, Psychological Behavioral: Accelerated Resolution Therapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accelerated Resolution Therapy for Treatment of Complicated Grief in Senior Adults
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Behavioral: Accelerated 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

Active Comparator: Wait list controlled Behavioral: Accelerated 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




Primary Outcome Measures :
  1. change in complicated grief symptoms [ Time Frame: 4 weeks, follow up at 12 weeks ]
    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.

  2. change in psychological trauma [ Time Frame: 4 weeks, follow up at 12 weeks ]
    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.

  3. change in depressive symptoms [ Time Frame: 4 weeks, follow up at 12 weeks ]
    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 :
  1. change in stress response [ Time Frame: weekly pre to post ART and over the 4 week intervention period ]
    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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484338


Contacts
Contact: Cindy Tofthagen, PhD 8133689862 ctofthag@health.usf.edu

Locations
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Cindy Tofthagen, PhD    813-368-9862    ctofthag@health.usf.edu   
Principal Investigator: Kip Kevin, PhD         
Principal Investigator: Cindy Tofthagen, PhD         
Sub-Investigator: Maureen Groer, PhD         
Sponsors and Collaborators
University of South Florida
  Study Documents (Full-Text)

Documents provided by Kevin Kip, University of South Florida:

Responsible Party: Kevin Kip, Distinguished Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT03484338     History of Changes
Other Study ID Numbers: 1R21AG056584-01 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Psychological Trauma
Behavioral Symptoms
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders