Guilt Focused Psychological Intervention

Status Terminated

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04656808
Study type	Interventional
Source	Universidad Rey Juan Carlos
Contact
Status	Terminated
Phase	N/A
Start date	June 1, 2016
Completion date	March 15, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Guilt Focused Psychological Intervention — LONG-CARE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms