Health TrialsbyHealthPanel

Accelerated Resolution Therapy for Early Maladaptive Grief

ConditionGrief
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorMayo Clinic

About this trial

The purpose study is to test the effects of accelerated resolution therapy (ART) on pre-loss grief and prolonged grief disorder among older adult family caregivers (FCGs). Additionally, to better understand predictors of response to ART, and cognitive processes that occur among grieving individuals following ART.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Primary caregiver of immediate family member who has a life expectancy of less than 12 months

Score of 30 or higher on the PG-12-R, indicating clinically significant pre-loss grief

Denial of suicidal ideation or intent, with no evidence of psychotic behavior.

Disqualifiers

Since becoming a family caregiver (FCG), they have engaged in another trauma based psychotherapeutic regimen (EMDR, prolonged exposure therapy, trauma focused cognitive behavioral therapy) that could influence response to accelerated resolution therapy (ART).

Self-reported or clinically assessed major psychiatric disorder (e.g., bipolar disorder, schizophrenia).

Score of > 2 on the adapted CAGE questionnaire indicating alcohol /drug dependence.

Cognitive impairment (SPMSQ > 4 errors).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Accelerated Resolution Therapy

    Behavioral

    A brief psychotherapeutic intervention delivered by trained therapists in a maximum of 4 sessions. Sessions will focus on providing relief from the distress related to an anticipated loss and to shift focus from distress and loss back to the relationship.

  • Information and Support

    Other intervention

    4 sessions of a standardized social work intervention. Standard of care including education and active listening.

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: Accelerated Resolution Therapy GroupExperimental treatment 1 intervention
Group B: Information and Support GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in pre-loss grief

Measured by 14-item self-reported Prolonged Grief-12-Revised (PG-12-R) designed to measure the grief experience of current family caregivers of persons living with progressive disease. Total grief level scores greater than or equal to 30 indicate high levels of pre-loss grief.

Time frame
Baseline, 4 weeks
2

Changes in prolonged grief disorder

Measured by 13-item self-reported Prolonged Grief-13-Revised (PG-13-R) designed to assess indicators of pathological grief. Total scores range from 10-50; with score \>29 = prolonged grief.

Time frame
6 and 13 months post-bereavement
3

Changes in clinical measure of prolonged grief disorder

Measured by 31-item Structured Clinical Interview for Prolonged Grief Disorder (SCI-P) administered by healthcare professional. Higher scores = higher complicated grief symptoms.

Time frame
6 and 13 months post-bereavement

Secondary outcomes

Other outcomes

1

Change in depression

Measured using the self-reported 9-item Personal Health Questionnaire (PHQ-9) to assess how often subjects have been bother about specific problems in the last 2 weeks. Total scores range from 0-27; with score \>9 = depression.

Time frame
Baseline, 4 weeks, 6 and 13 months post-bereavement
2

Caregiver burden

Measured using the self-reported 4-item Caregiver Role Overload questionnaire. Individual statement agreement on scale of "completely" agree to "not at all". Higher responses indicate more burden.

Time frame
Baseline
3

Change in perceived stress

Measured using the self-reported 10-item NIH toolbox Item Bank/Fixed Form v2.0 - Perceived Stress questionnaire. Score range from 26-34; with higher score indicating worse stress.

Time frame
Baseline, 6 and 13 months post-bereavement
4

Change in physical and mental health

Measured using the self-reported 10-item Patient-Reported Outcomes Measurement Information System (PROMIS)-Global Health questionnaire. Total score range 0-20; with higher scores indicate better health.

Time frame
Baseline, 6 and 13 months post-bereavement

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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