GuiltLONG-CARENCT04656808
Guilt Focused Psychological Intervention
A study testing Guilt Focused Intervention and Cognitive behavioral therapy in people with Guilt and Depressive Symptoms, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Guilt, Depressive Symptoms, Anxious Symptoms
- What is being tested?
- Guilt Focused Intervention and Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2016to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Those different to the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Guilt, Depressive Symptoms, Anxious Symptoms, Stress, Physiological
- Being tested
- Guilt Focused Intervention, Cognitive behavioral therapy
- Keywords
- Caregivers, Dementia, Depression, Anxiety, Stress, Guilt, Psychotherapy
- Medical subject headings
- Depression, Dementia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guilt Focused InterventionBehavioural
Psychotherapy, group intervention
Cognitive behavioral therapyBehavioural
Psychotherapy, group intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guilt symptoms
Caregivers' feelings of guilt are measured using the Caregiver Guilt Questionnaire (Losada, A., Márquez-González, M., Peñacoba, C., \& Romero-Moreno, R., 2010)
Measured: 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
Measured: 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)
Measured: Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)
Secondary outcomes (1)
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)
Measured: Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start1 Jun 2016
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GuiltStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two treatment conditions
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Principal investigator, Andrés Losada Baltar, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656808
- Sponsor's protocol ID
- PSI2015-65152-C2-1-R
- Acronym
- LONG-CARE
- Status last verified
- Dec 2020
- First submitted
- 29 Nov 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Under request to the Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guilt Feelings, Dysfunctional Thoughts, Cultural Values and Mental and Physical Health of Dementia Family Caregivers: Longitudinal, Intervention and Experimental Analysis
- ClinicalTrials.gov ID
- NCT04656808
- Acronym / sponsor ID
- LONG-CARE / PSI2015-65152-C2-1-R
- Conditions
- Guilt, Depressive Symptoms, Anxious Symptoms, Stress, Physiological
- Keywords
- Caregivers, Dementia, Depression, Anxiety, Stress, Guilt, Psychotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two treatment conditions
| Arm | Type | Receives |
|---|---|---|
| Guilt focused intervention | Experimental | Behavioral: Guilt Focused InterventionFollowing 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. |
| Cognitive behavioral therapy | Active comparator | Behavioral: Cognitive behavioral therapyFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- Those different to the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guilt Focused InterventionPsychotherapy, group intervention | Behavioural | Guilt focused intervention |
| Cognitive behavioral therapyPsychotherapy, group intervention | Behavioural | Cognitive behavioral therapy |
Primary outcome
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)
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
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)
1 secondary outcome
Caregiving stressors
Time frame: Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Individual participant dataSharing planned: Yes. Under request to the Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guilt Focused Intervention and Cognitive behavioral therapy in people with Guilt and Depressive Symptoms, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Guilt symptoms (time frame: Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.