Reducing Mental Health in Informal Caregivers

Study Overview
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Brief Summary
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The overarching goal of this project is to evaluate if evidence-based interventions can reduce PDG, burden, and stress in informal caregivers of individuals with dementia

Detailed Description
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Aim 1: Examine the effects of two individual evidence-based therapies for informal caregivers of dementia patients. Aim 2: Examine the effects of a modified evidence-based group therapy for informal caregivers of dementia patients.

Official Title
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Reducing Pre-Death Grief, Burden, and Stress in Informal Caregivers: A Group and Individual Therapy Approach

Conditions
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Mental Health Issue, Grief, Burden, Caregiver

Intervention / Treatment
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* Behavioral: Mindfulness Based Cognitive Therapy
* Behavioral: Behavior Activation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be informal caregivers (e.g., spouse; child; close friend) of individuals with dementia Informal caregivers can be family members or close friends Adults (18 to 89 years old) who read, write, and speak in English Mental Health Diagnosis (e.g., Generalized Anxiety Disorder; Major Depressive Disorder Exclusion Criteria: Formal caregivers (who are being paid to take care of the patient) Any informal caregivers with cognitive impairment is identified during the assessment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Mindfulness Based Cognitive Therapy; Behavior Activation; Group Therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Based Cognitive Therapy<br>Mindfulness-Based Cognitive Therapy (MBCT) combines the ideas of cognitive therapy with meditative practices and attitudes based on the cultivation of mindfulness. The heart of this work lies in becoming acquainted with the modes of mind that often characterize mood disorders while simultaneously learning to develop a new relationship to them. | Behavioral: Mindfulness Based Cognitive Therapy<br>* Individual therapy 12 to 16 weeks<br>* Other names: MBCT;|
| Experimental: Behavior Activation<br>BA Increase reinforcing behaviors in order to influence emotions and cognitions. | Behavioral: Behavior Activation<br>* Individual therapy 12 to 16 weeks<br>* Other names: BA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged Grief Scale-12 (measuring pre-death grief) | The PG-12 (range 11-55; higher scores mean higher pre-death grief), which is used to measure pre-death grief will be used to measure grief of having a loved one live with a life limiting illness and no longer be able to engage in valued activites. | through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zarit Burden Inventory (ZBI) | Informal caregivers, usually family member, have an increase in burden or feeling they are overwhelmed by their current circumstances. The ZBI is between 0-48, higher scores indicating higher burden. | through study completion, an average of 6 months | 
| Perceived Stress Scale | Informal caregivers, usually family members, are unpaid and have a tendency to feel tense and emotionally drained do to caregiving. Scores range from 0-40 with higher scores indicating higher rates of stress. | through study completion, an average of 6 months |