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Guilt Focused Psychological Intervention (LONG-CARE)

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ClinicalTrials.gov Identifier: NCT04656808
Recruitment Status : Terminated (COVID-19)
First Posted : December 7, 2020
Last Update Posted : December 7, 2020
Sponsor:
Collaborator:
Ministerio de Economía y Competitividad, Spain
Information provided by (Responsible Party):
Andrés Losada Baltar, Universidad Rey Juan Carlos

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Guilt Depressive Symptoms Anxious Symptoms Stress, Physiological Behavioral: Guilt Focused Intervention Behavioral: Cognitive behavioral therapy Not Applicable

Detailed Description:
  1. Contact with collaborator centers. Centers with previous collaboration with the research team will provide contact data of potential participants. In addition, information of the project will be made available through posters, news, and internet (e.g., social networks).
  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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial with two treatment conditions
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants and assessors are blinded to the study research objectives and aims and to the available and obtained treatment condition.
Primary Purpose: Treatment
Official Title: Guilt Feelings, Dysfunctional Thoughts, Cultural Values and Mental and Physical Health of Dementia Family Caregivers: Longitudinal, Intervention and Experimental Analysis
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : March 15, 2020
Actual Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Caregivers

Arm Intervention/treatment
Experimental: 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.
Behavioral: Guilt Focused Intervention
Psychotherapy, group intervention

Active Comparator: 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.
Behavioral: Cognitive behavioral therapy
Psychotherapy, group intervention




Primary Outcome Measures :
  1. Guilt symptoms [ Time Frame: Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention) ]
    Caregivers' feelings of guilt are measured using the Caregiver Guilt Questionnaire (Losada, A., Márquez-González, M., Peñacoba, C., & Romero-Moreno, R., 2010)

  2. Depressive symptoms [ Time Frame: Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention) ]
    The Center for Epidemiological Studies-Depression Scale (CES-D; Radloff, 1977) is used

  3. Anxiety symptoms [ Time Frame: Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention) ]
    Caregivers' symptoms of anxiety are measured through the Tension-Anxiety subscale from the Profile of Mood States (POMS; McNair, Lorr, & Droppleman, 1971)


Secondary Outcome Measures :
  1. Caregiving stressors [ Time Frame: Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention) ]
    Care-recipients' behavioral and psychological symptoms were measured with the disruptive behaviors subscale of the Revised Memory and Behavior Problems Checklist (RMBPC; Teri, 1992)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Identifying themselves as the main caregiver of the relative with dementia
  • 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).

Exclusion Criteria:

  • Those different to the inclusion criteria

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): NCT04656808


Locations
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Spain
Universidad Rey Juan Carlos
Madrid, Alcorcón, Spain, 28922
Sponsors and Collaborators
Universidad Rey Juan Carlos
Ministerio de Economía y Competitividad, Spain
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Responsible Party: Andrés Losada Baltar, Full Professor, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT04656808    
Other Study ID Numbers: PSI2015-65152-C2-1-R
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Under request to the Principal Investigator
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Once the study is published
Access Criteria: Upon request to the Principal Investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrés Losada Baltar, Universidad Rey Juan Carlos:
Caregivers
Dementia
Depression
Anxiety
Stress
Guilt
Psychotherapy
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms