NCT04656808

Guilt Focused Psychological Intervention

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Universidad Rey Juan Carlos · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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).

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Guilt Focused Intervention	Psychotherapy, group intervention
BEHAVIORAL	Cognitive behavioral therapy	Psychotherapy, group intervention

Timeline

• Start date: 2016-06-01
• Primary completion: 2020-03-15
• Completion: 2020-03-15
• First posted: 2020-12-07
• Last updated: 2020-12-07

Locations

1 site across 1 country: Spain