Psychological Support for Critical Illness

Overseen By ACRU

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Dementia, Intellectual disability, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of ICU stay

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a psychological support approach can help critically ill patients feel more at ease. The treatment provides ICU patients with positive suggestions and explanations about their situation. Participants will receive either this psychological support or no intervention. Ideal candidates are critically ill adults who require breathing support, such as a ventilator, and are expected to remain in the ICU for more than two days. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance ICU care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this psychotherapeutic approach is safe for critically ill patients?

Research shows that doulas in healthcare settings are generally safe and well-received. Studies on childbirth have found that doulas help improve outcomes, such as reducing the need for cesarean sections and lowering the risk of postpartum depression. One small study examined trained doulas in the ICU, where they provided positive support to seriously ill patients. This approach aims to offer emotional support during difficult times. Although these findings are encouraging, the evidence remains limited. However, no major safety issues have been reported, indicating that this type of support is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Psychological Support Based on Positive Suggestions (PSBPS) because it offers a fresh approach to supporting critical illness patients. Unlike typical treatments that focus on medical interventions, PSBPS harnesses the power of positive mental reinforcement to aid recovery. This technique could provide a non-invasive, complementary option to standard care, potentially enhancing patient well-being and outcomes by boosting their mental resilience during recovery. By integrating psychological support, researchers hope to uncover new pathways for holistic healing in critical care settings.

What evidence suggests that Psychological Support Based on Positive Suggestions is effective for critically ill patients?

Research has shown that positive psychological support can help critically ill patients. In this trial, one arm involves ICU doulas providing support during patients' most vulnerable times. Most nurses in earlier studies found the doulas' assistance beneficial for both patients and healthcare staff. Although evidence remains limited, some findings suggest that this support can enhance patients' feelings and recovery. The support includes reassuring patients and clearly explaining their situations, which can reduce stress and confusion during serious illness. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for critically ill adults over 18 who need breathing support like non-invasive ventilation or mechanical ventilation and will likely stay in the ICU for more than 48 hours. It's not for those with dementia, severe brain dysfunction due to liver problems, on end-of-life care, unlikely to survive their hospital stay, don't speak English, have a history of serious mental illness or substance issues.

Inclusion Criteria

I am an adult in critical condition needing breathing support and expected to stay in care for more than 48 hours.

Exclusion Criteria

I am receiving care focused on my comfort.

I have been diagnosed with a psychotic disorder like schizophrenia.

You have an intellectual disability.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive psychological support based on positive suggestions (PSBPS) administered by trained ICU doulas daily during their ICU stay

Duration of ICU stay

Daily visits (in-person)

Follow-up

Participants are monitored for psychological and cognitive outcomes after ICU discharge

3 months

Follow-up by phone

Long-term Follow-up

Participants complete follow-up questionnaires measuring symptoms of anxiety, depression, acute stress, and cognitive function

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Psychological Support Based on Positive Suggestions (PSBPS)

Trial Overview The study tests a psychological support method using positive suggestions given daily in the ICU. The goal is to see if this approach helps improve mental health and cognitive function in patients facing critical illnesses.

How Is the Trial Designed?

Group I: Doula Experimental Treatment 1 Intervention

Group II: No Intervention Active Control 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The case report highlights the successful integration of psychological support based on positive suggestions (PSBPS) with traditional treatment for a 36-year-old male patient with acute pancreatitis, demonstrating its potential as an effective adjunct therapy in critical care settings.

After implementing PSBPS, the patient showed significant improvements in cooperation, recovery motivation, and overall medical condition, leading to a full recovery and return to work within 10 months post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological support based on positive suggestions in the treatment of a critically ill ICU patient - A case report. Varga, K., Varga, Z., Fritúz, G.[2021]

Mainstream psychotherapy has traditionally focused on treating symptoms of mental disorders but has often neglected the pursuit of happiness as a therapeutic goal, despite clients expressing a desire for happiness.

Positive psychology interventions offer systematic approaches to address various clinical problems by leveraging clients' strengths, rather than simply minimizing negatives, and can be integrated into a hybrid psychotherapy-coaching model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive interventions in clinical practice. Rashid, T.[2022]

Critically ill patients and their families experience high levels of mental stress, highlighting the need for integrated psychological care in intensive care units (ICUs) to address these challenges.

Psychological support in the ICU, provided by qualified professionals, aims to detect and treat mental symptoms in patients, offer crisis support to relatives, and assist staff in managing communication and coping strategies, ultimately enhancing the overall care experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychological care in the intensive care unit : Task areas, responsibilities, requirements, and infrastructure]. Deffner, T., Michels, G., Nojack, A., et al.[2020]

A small study involving 20 intubated patients showed that delivering psychological support based on positive suggestion by intensivists may help reduce psychological distress after acute respiratory failure, with 38% of patients meeting criteria for anxiety, depression, or acute stress.

Of the 13 patients who completed follow-up surveys, many found the intervention comforting, suggesting that PSBPS could be a valuable addition to medical treatment in critical care, warranting further research in a larger randomized study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Behavioral Intervention to Reduce Psychological Distress in Mechanically Ventilated Patients. Tan, Y., Gajic, O., Schulte, PJ., et al.[2021]

A program was successfully implemented to train doulas to provide psychological support based on positive suggestion to 43 critically ill patients in the ICU, showing that this approach can be beneficial even in altered cognitive states.

Feedback from patients, families, and ICU nurses was overwhelmingly positive, with 37 out of 40 patients recalling the intervention as comforting, indicating that doulas can effectively enhance emotional support in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

System of Psychological Support Based on Positive Suggestions to the Critically Ill Using ICU Doulas. Karnatovskaia, LV., Schultz, JM., Niven, AS., et al.[2022]

A systematic review of 29 studies, including 23 controlled trials, found that positive psychology interventions significantly improve stress-related symptoms, such as anxiety and posttraumatic stress disorder.

Despite the promising results, the review highlighted important methodological biases and variability among studies, indicating a need for further research to validate the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive interventions for stress-related difficulties: A systematic review of randomized and non-randomized trials. Ferrandez, S., Soubelet, A., Vankenhove, L.[2022]

Psychological support during ICU treatment, including techniques like relaxation and guided imagery, significantly improves patients' psychological and physiological outcomes, such as vital signs, pain levels, anxiety, and overall satisfaction.

The review of 14 studies indicates that systematic psychological support from nurses can lead to shorter hospital stays and better recovery, highlighting the need for ICU nurses to prioritize these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological support and outcomes for ICU patients. Papathanassoglou, ED.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8691072/

A pilot study of trained ICU doulas providing early ... Results. Forty-three patients (see Fig. 1) received the PSBPS intervention provided by two trained ICU doulas for a median of 4 days (3, 5) ...

2. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-021-03856-3

A pilot study of trained ICU doulas providing early ... In this project, ICU doulas delivered a unique positive suggestion intervention targeting the vulnerable time period during critical illness when these ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1049386724000215

United States Doula Programs and Their Outcomes Some studies have found associations between doula care and improved clinical outcomes for birthing people and infants, the evidence is limited.

4. healthlaw.org healthlaw.org/doula-care-improves-health-outcomes-reduces-racial-disparities-and-cuts-cost/

Doula Care Improves Health Outcomes, Reduces Racial ... Doula care reduces overall perinatal spending​​ Rigorous studies show that doula care results in substantial cost savings by reducing the need ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8078413/

System of Psychological Support Based on Positive ... The majority (28/32) of surveyed bedside ICU nurses reported that the doulas' involvement was helpful for both patients and nurses alike. All ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10292163/

The Effect of Doulas on Maternal and Birth Outcomes The studies in this review indicated that doula guidance in perinatal care was associated with positive delivery outcomes including reduced cesarean sections.

7. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(22)00261-9/fulltext

Evaluation of doula programs across three states using ... Women who received doula care had 52.9% lower odds of cesarean delivery (OR: 0.471 95% CI: 0.29–0.79) and 57.5% lower odds of postpartum depression/postpartum ...