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| Name | Class |
|---|---|
| Ministerio de EconomÃa y Competitividad, Spain | OTHER_GOV |
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Participants in the intervention study will be 120 caregivers with guilt feelings linked with care and high levels of emotional distress (anxiety and/or depression), randomly allocated to the intervention conditions: intervention group and cognitive-behavioral comparison group. The intervention will be provided in a group setting and will consist in 8 sessions plus 3 booster sessions. The effect of the intervention on guilt feelings, depressive and anxious symptomatology, and biomarkers of cardiovascular risk will be assessed after the intervention and at follow-ups at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guilt focused intervention | Experimental | Following literature on factors associated with guilt experiences in caregivers (Gonyea et al., 2008; Gallego-Alberto et al., 2019; Losada et al., 2014; Prunty & Foli, 2019; Romero-Moreno et al., 2014; Spillers et al., 2008) and previous intervention studies testing an Acceptance and Commitment Therapy intervention for dementia family caregivers (Losada et al., 2015; Márquez-González et al., 2020), a guilt focused intervention was specifically designed for caregivers who experienced high levels of guilt and emotional distress. The program is based on CBT (Márquez-González et al., 2007) and Acceptance and Commitment Therapy (ACT) approaches (Losada et al., 2005; Márquez-González et al., 2010), combined with techniques of Compassion-Focused Therapy (CFT; Gilbert, 2009), which were adapted to work with guilt experienced by family dementia caregivers. |
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| Cognitive behavioral therapy | Active Comparator | Following the cognitive behavioral model adapted to caregiving (Losada et al., 2006) and considering other previous CBT intervention studies with dementia caregivers (Gallagher-Thompson et al., 2003), a CBT intervention developed and tested for dementia family caregivers (Márquez-González et al., 2007) was used for this study. Specifically, this intervention consists of different components that are described in more detail in Losada et al. (2011) and Márquez-González et al. (2007): a) a cognitive restructuring module aimed at modifying caregivers' dysfunctional thoughts about caregiving into other, more appropriate thoughts which promote the use of more adaptive coping strategies for caregivers; b) increasing pleasant activities or behavioral activation; c) asking for help skills; and d) relaxation techniques for reducing physiological activation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guilt Focused Intervention | Behavioral | Psychotherapy, group intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Guilt symptoms | Caregivers' feelings of guilt are measured using the Caregiver Guilt Questionnaire (Losada, A., Márquez-González, M., Peñacoba, C., & Romero-Moreno, R., 2010) | Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention) |
| Depressive symptoms | The Center for Epidemiological Studies-Depression Scale (CES-D; Radloff, 1977) is used | Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention) |
| Anxiety symptoms | Caregivers' symptoms of anxiety are measured through the Tension-Anxiety subscale from the Profile of Mood States (POMS; McNair, Lorr, & Droppleman, 1971) | Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiving stressors | Care-recipients' behavioral and psychological symptoms were measured with the disruptive behaviors subscale of the Revised Memory and Behavior Problems Checklist (RMBPC; Teri, 1992) | Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Rey Juan Carlos | Madrid | Alcorcón | 28922 | Spain |
Under request to the Principal Investigator
Once the study is published
Upon request to the Principal Investigator
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003704 | Dementia |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Randomized controlled trial with two treatment conditions
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Participants and assessors are blinded to the study research objectives and aims and to the available and obtained treatment condition.
| Cognitive behavioral therapy |
| Behavioral |
Psychotherapy, group intervention |
|
| D009422 |
| Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |