LONG-CARE: Guilt Focused Psychological Intervention

Sponsor

Universidad Rey Juan Carlos (Other)

Overall Status

Terminated

CT.gov ID

NCT04656808

Collaborator

Ministerio de Economía y Competitividad, Spain (Other)

110

Enrollment

Location

Arms

45.4

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Guilt Depressive Symptoms Anxious Symptoms Stress, Physiological	Behavioral: Guilt Focused Intervention Behavioral: Cognitive behavioral therapy	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trial with two treatment conditionsRandomized 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 :

Jun 1, 2016

Actual Primary Completion Date :

Mar 15, 2020

Actual Study Completion Date :

Mar 15, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Guilt symptoms [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)
Depressive symptoms [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
Anxiety symptoms [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

Caregiving stressors [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).