Guilt Focused Psychological Intervention

Depressive Symptoms Clinical Trial

— LONG-CARE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04656808
• Other study ID #: PSI2015-65152-C2-1-R
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: March 15, 2020

Study information

• Verified date: December 2020
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxious Symptoms
• Depression
• Depressive Symptoms
• Guilt
• Stress, Physiological

Intervention

Behavioral:
• Guilt Focused Intervention
Psychotherapy, group intervention
• Cognitive behavioral therapy
Psychotherapy, group intervention

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos	Madrid	Alcorcón

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos	Ministerio de Economía y Competitividad, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)	Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)