Guilt Focused Psychological Intervention (LONG-CARE)

December 4, 2020 updated by: Andrés Losada Baltar, Universidad Rey Juan Carlos

Guilt Feelings, Dysfunctional Thoughts, Cultural Values and Mental and Physical Health of Dementia Family Caregivers: Longitudinal, Intervention and Experimental Analysis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alcorcón
      • Madrid, Alcorcón, Spain, 28922
        • Universidad Rey Juan Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)
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
Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)
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)
Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Rey Juan Carlos

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministerio de Economía y Competitividad, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSI2015-65152-C2-1-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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