Guilt Focused Psychological Intervention

NCT04656808 | Terminated

• 1 other identifier: PSI2015-65152-C2-1-R
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Guilt; Depressive Symptoms; Anxious Symptoms; Stress, Physiological

Keywords

Caregivers; Dementia; Depression; Anxiety; Stress; Guilt; Psychotherapy

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (1)

• Caregiving stressors

  Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)

Study Arms (2)

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.

Behavioral: Guilt Focused Intervention

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.

Behavioral: Cognitive behavioral therapy

Interventions

Guilt Focused Intervention BEHAVIORAL

Psychotherapy, group intervention

Guilt focused intervention

Cognitive behavioral therapy BEHAVIORAL

Psychotherapy, group intervention

Cognitive behavioral therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

Universidad Rey Juan Carlos

Madrid, Alcorcón, 28922, Spain

Location

MeSH Terms

Conditions

Depression; Dementia; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and assessors are blinded to the study research objectives and aims and to the available and obtained treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Randomized controlled trial with two treatment conditions

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: December 7, 2020
• Study Start: June 1, 2016
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Once the study is published
• Access Criteria: Upon request to the Principal Investigator

Locations

ES (1)