Clinical trial NCT04656808: Guilt Focused Psychological Intervention
Official title: Guilt Feelings, Dysfunctional Thoughts, Cultural Values and Mental and Physical Health of Dementia Family Caregivers: Longitudinal, Intervention and Experimental Analysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Guilt
Depressive Symptoms
Anxious Symptoms
Stress, Physiological
Keywords: Caregivers
Dementia
Depression
Anxiety
Stress
Guilt
Psychotherapy
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2020-12-07
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two treatment conditions
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Guilt symptoms
timeFrame: Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)
measure: Depressive symptoms
timeFrame: Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)
measure: Anxiety symptoms
timeFrame: Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)
Secondary outcomes:
measure: Caregiving stressors
timeFrame: Pre-intervention, post-intervention (two months after the intervention) and follow-up (6 months after the intervention)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Rey Juan Carlos
state: Alcorcón
Study officials:
References: