Covid19, Post Traumatic Stress Disorder, Solid Carcinoma
Conditions
Brief summary
In the context of the COVID-19 pandemic, concerns of the risk of infection may lead to fear, anxiety or psychological disorders that may become generalised and long-lasting, corresponding to post-traumatic stress disorder (PTSD). PTSD generally occurs in circumstances such as terrorist attacks, hostage-taking, bombings, aggression, accidents... The current health crisis also represents an increased risk of PTSD. After the first moments of stress, the illness becomes more diffuse: personality change (introverted/extraverted), sleep disorders, heart problems, hypervigilance reaction, agoraphobia, symptoms of reminiscence, irritability, decreased concentration, memory loss... In some people, PTSD can lead to more disabling problems such as (crowd) avoidance. In order to help patients with PTSD, clinical psychology offers therapeutic approaches which, starting from a debriefing with the patient, provide supportive therapy which (i) reassures by providing information on the symptomatology, in order to play down the present state of mind, (ii) allows for the expression of what was experienced during the event, (iii) initiates a process of elaboration of the trauma through transference. A previous study conducted at the François Baclesse Center during the first COVID-19 lockdown (April to June 2020), which included 735 patients, assessed the impact of the pandemic on cancer patients treated in day hospitals. That study found that 21% of patients met criteria for post-traumatic stress disorder (PTSD) and 23% reported insomnia. Based on these findings, the present study was designed to evaluate the effectiveness of an adapted psychological intervention for patients with pandemic-related PTSD.
Interventions
OTHERPsychological support
Psychological care will be based on a monthly interview lasting approximately 45 minutes for 6 months.
Sponsors
Centre Francois Baclesse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Psychological support
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient ≥ 18 years old * Patient treated or followed up for a solid tumour at the François Baclesse Centre * Patient with a score suggesting moderate or high posttraumatic stress symptoms (IES-R score ≥ 24) related to the COVID-19 epidemic * The patient's state of health is compatible with the programme: psychological care for 6 months. * Information note signed by the patient * Any associated geographical, social or psychopathological conditions that might compromise the patient's ability to participate in the study
Exclusion criteria
* Patient with no symptoms suggestive of moderate or high post-traumatic stress (IES-R score \<24) * Patient deprived of liberty or under guardianship * Patient already receiving psychological care * Patient whose diagnosis of the disease was made within one month prior to the proposal for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Improvement in Post-traumatic Stress Symptoms | 6 months | Improvement in post-traumatic stress symptoms observed during or at the end of the intervention, defined as a decrease below the threshold of 24 on the Impact of Event Scale-Revised (IES-R) compared with baseline. The Impact of Event Scale-Revised (IES-R) is a 22-item self-report questionnaire assessing post-traumatic stress symptoms across intrusion, avoidance, and hyperarousal domains, with total scores ranging from 0 to 88 and higher scores indicating higher symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resilience Scores | 6 months | Done with Connor-Davidson Resiliency Scale. The Connor-Davidson Resilience Scale (CD-RISC) is a self-report questionnaire (commonly 25 items) assessing resilience, with total scores ranging from 0 to 100 and higher scores indicating greater resilience. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAntony NARAYANASSAMY, M
Centre François Baclesse
Participant flow
Pre-assignment details
Patients aged ≥18 years, treated or followed for a solid tumor at Centre François Baclesse, and presenting moderate to high post-traumatic stress symptoms (score ≥24 on the Impact of Event Scale-Revised (IES-R)) related to the COVID-19 epidemic.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62 Years |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 29 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
None listed