Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
110 participants
INTERVENTIONAL
2016-06-01
2020-03-15
Brief Summary
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Detailed Description
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2. Previous to the assessment each participant will be randomly allocated to the intervention conditions (guilt focused intervention (GFI) and cognitive behavioral therapy (CBT)) following the CONSORT recommendations. Randomization will be made through random numbers using computerized procedures.
3. Once contacted, caregivers will be requested to sign an informed consent and, if the inclusion criteria are met, the interview will take place. Interviews will be conducted by trained psychologists blinded to the project aims and hypothesis.
4. The interviews will consist in questions and questionnaires specifically selected for the project.
5. The intervention conditions have been developed following previous studies by the team or recognized researchers, or following previous research studies in the topic of caregiving stress or related topics (e.g. psychotherapeutic strategies for reducing distress).
6. The interventions will take place in group format (maximum 8 participants per group). Each intervention will consist in 8 weekly sessions plus 3 booster sessions in a 5 month period.
7. Participants will be assessed again after the intervention (2 months) and at the follow-up (6 months).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Guilt focused intervention
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.
Guilt Focused Intervention
Psychotherapy, group intervention
Cognitive behavioral therapy
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.
Cognitive behavioral therapy
Psychotherapy, group intervention
Interventions
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Guilt Focused Intervention
Psychotherapy, group intervention
Cognitive behavioral therapy
Psychotherapy, group intervention
Eligibility Criteria
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Inclusion Criteria
* Dedicating at least one daily hour to caregiving tasks
* Having cared for at least three consecutive months
* Not having participated in a psychotherapeutic intervention in the last year
* Showing scores equal or higher than 16 on the Center for Epidemiological Studies-Depression Scale (CES-D; Radloff, 1977) and/or 13 on the Tension-Anxiety subscale from the Profile of Mood States scale (POMS; McNair et al., 1971)
* Showing a score of at least 16 in the Caregiver Guilt Questionnaire (Losada et al., 2010).
18 Years
ALL
Yes
Sponsors
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Ministerio de Economía y Competitividad, Spain
OTHER_GOV
Universidad Rey Juan Carlos
OTHER
Responsible Party
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Andrés Losada Baltar
Full Professor
Locations
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Universidad Rey Juan Carlos
Madrid, Alcorcón, Spain
Countries
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Other Identifiers
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PSI2015-65152-C2-1-R
Identifier Type: -
Identifier Source: org_study_id