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Guilt Focused Psychological Intervention (LONG-CARE)

Primary Purpose

Guilt, Depressive Symptoms, Anxious Symptoms

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Guilt Focused Intervention
Cognitive behavioral therapy
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Guilt focused on measuring Caregivers, Dementia, Depression, Anxiety, Stress, Guilt, Psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad Rey Juan Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Guilt focused intervention

Cognitive behavioral therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Guilt symptoms
Caregivers' feelings of guilt are measured using the Caregiver Guilt Questionnaire (Losada, A., Márquez-González, M., Peñacoba, C., & Romero-Moreno, R., 2010)
Depressive symptoms
The Center for Epidemiological Studies-Depression Scale (CES-D; Radloff, 1977) is used
Anxiety symptoms
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

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)

Full Information

First Posted
November 29, 2020
Last Updated
December 4, 2020
Sponsor
Universidad Rey Juan Carlos
Collaborators
Ministerio de Economía y Competitividad, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT04656808
Brief Title
Guilt Focused Psychological Intervention
Acronym
LONG-CARE
Official Title
Guilt Feelings, Dysfunctional Thoughts, Cultural Values and Mental and Physical Health of Dementia Family Caregivers: Longitudinal, Intervention and Experimental Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
Collaborators
Ministerio de Economía y Competitividad, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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). 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. 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. The interviews will consist in questions and questionnaires specifically selected for the project. 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). 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. Participants will be assessed again after the intervention (2 months) and at the follow-up (6 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Guilt, Depressive Symptoms, Anxious Symptoms, Stress, Physiological
Keywords
Caregivers, Dementia, Depression, Anxiety, Stress, Guilt, Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with two treatment conditions
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and assessors are blinded to the study research objectives and aims and to the available and obtained treatment condition.
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guilt focused intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive behavioral therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Guilt Focused Intervention
Intervention Description
Psychotherapy, group intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Description
Psychotherapy, group intervention
Primary Outcome Measure Information:
Title
Guilt symptoms
Description
Caregivers' feelings of guilt are measured using the Caregiver Guilt Questionnaire (Losada, A., Márquez-González, M., Peñacoba, C., & Romero-Moreno, R., 2010)
Time Frame
Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)
Title
Depressive symptoms
Description
The Center for Epidemiological Studies-Depression Scale (CES-D; Radloff, 1977) is used
Time Frame
Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)
Title
Anxiety symptoms
Description
Caregivers' symptoms of anxiety are measured through the Tension-Anxiety subscale from the Profile of Mood States (POMS; McNair, Lorr, & Droppleman, 1971)
Time Frame
Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)
Secondary Outcome Measure Information:
Title
Caregiving stressors
Description
Care-recipients' behavioral and psychological symptoms were measured with the disruptive behaviors subscale of the Revised Memory and Behavior Problems Checklist (RMBPC; Teri, 1992)
Time Frame
Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Madrid
State/Province
Alcorcón
ZIP/Postal Code
28922
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Under request to the Principal Investigator
IPD Sharing Time Frame
Once the study is published
IPD Sharing Access Criteria
Upon request to the Principal Investigator

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Guilt Focused Psychological Intervention

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