An interventional study of Psychological support in Solid Carcinoma, Post Traumatic Stress Disorder and Covid19, sponsored by Centre Francois Baclesse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Centre Francois Baclesse · Not applicable, Interventional, and Treatment
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.
2,237 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 553 are open to participants now.
This study's enrollment of 29 is below the median of 70 across 1,856 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Centre Francois Baclesse is the lead sponsor of 109 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Monthly psychological support
Other: Psychological support
Psychological care will be based on a monthly interview lasting approximately 45 minutes for 6 months.
Proportion of Patients With Improvement in Post-traumatic Stress Symptoms
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.
Time frame: 6 months
Resilience Scores
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.
Time frame: 6 months
| Milestone | Psychological Support |
|---|---|
| Started | 29 |
| Completed | 22 |
| Not completed | 7 |
| Withdrew: Death | 2 |
| Withdrew: Patient's decision | 5 |
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.
| Participants | Psychological Support |
|---|---|
| Proportion of Patients With Improvement in Post-traumatic Stress Symptoms | 12 |
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.
| Score range 0 to 100 | Psychological Support |
|---|---|
| Resilience Scores | 62 (18 to 93) |
Collected over 6 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Psychological Support | 2/29 (6.9%) | — | — |
All patients included were described at baseline
| Age, Continuous(Years) | Psychological Support |
|---|---|
| Median | 62 (39 to 80) |
| Sex: Female, Male(Participants) | Psychological Support |
|---|---|
| Female | 26 |
| Male | 3 |
| Race and Ethnicity Not Collected(Participants) | Psychological Support |
|---|
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic→
Centre Francois Baclesse