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The investigators will compare a dyadic intervention (Recovering Together) with an attention placebo educational control in dyads of patients with acute neurological illnesses and their caregivers at risk for chronic emotional distress. The primary aim of this study is to determine the feasibility, credibility, and satisfaction with Recovering Together. The second aim is to show proof of concept for sustained improvement in emotional distress, post traumatic stress (PTS), resiliency and interpersonal communication outcomes in patients and caregivers.
The investigators aim to improve the care of patients (pts) admitted to the Neuroscience Intensive Care Unit (NICU) and their family caregivers (cgs) by conducting a pilot feasibility randomized controlled trial (RCT; N=80 dyads; 60 completers) of the dyadic resiliency program ("Recovering Together") to prevent chronic emotional distress in both pts and their cgs. Eligible dyads include adult, English speaking pts with acute neurological injury (ANI) admitted to the NICU, cleared medically and cognitively for participation by the nursing team, and their primary cgs. Dyads who are randomly assigned to "Recovering Together" will receive 6 manualized sessions (2 in person at hospitalization and 4 through live video after discharge, to reduce burden and facilitate access to care) led by a clinical psychologist. Dyads who are randomly assigned to the attention placebo educational control condition will receive 6 manualized sessions (2 in person and 4 through live video with a clinical psychologist), modeled after the Recovering Together program that will control for the dose of the intervention and support from therapist. Dyads will complete assessment surveys before, after the intervention and 3 months later. Clinical data on demographics, diagnosis, ANI severity, and any medical complications will be extracted from electronic health records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recovering Together | Experimental | Dyads who are randomly assigned to the Recovering Together program will receive any usual clinic care as determined by their clinicians. Additionally, dyads will be invited to participate in 6 30-minute skills sessions. All sessions will include both pt and cg. A clinical psychologist will deliver the majority of sessions while the PI will deliver at least 10% of the sessions. The main intervention goal is to provide dyads with resiliency and interpersonal communication skills necessary to optimize their recovery and reduce emotional distress and PTS. |
|
| Health Education | No Intervention | Patients randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recovering Together | Behavioral | The intervention will teach resiliency skills (mindfulness, coping, interpersonal communication, etc) within 2 in person sessions at hospitalization and 4 live video sessions after discharge. Both patient and caregiver will participate in all sessions |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment (Ability to Recruit Dyads) | Feasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled | Baseline |
| Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads) | We will report number of sessions completed by each dyad. We will report any technical difficulties with live video delivery | Feasibility of program delivery will be measured at 6 weeks |
| Credibility and Expectancy Questionnaire | This measure will assess participants' belief that the intervention (or control) will be helpful. The score range is 3-27. Higher scores mean higher perception of credibility or expectancy. | Baseline |
| Client Satisfaction Questionnaire | This measure will assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction. | post intervention (6 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression Scale | Measures symptoms of emotional distress and estimates diagnoses. The scale has 14 items, 7 assess anxiety and 7 depression. Scores range from 0-21 on each subscale, wtih higher scores indicating more symptoms. Scores greater than 8 indicate clinically significant symptoms. | baseline to posttest to 3 months follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana-Maria Vranceanu, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36869208 | Derived | Brasil S, de Carvalho Nogueira R, Salinet ASM, Yoshikawa MH, Teixeira MJ, Paiva W, Malbouisson LMS, Bor-Seng-Shu E, Panerai RB. Critical Closing Pressure and Cerebrovascular Resistance Responses to Intracranial Pressure Variations in Neurocritical Patients. Neurocrit Care. 2023 Oct;39(2):399-410. doi: 10.1007/s12028-023-01691-8. Epub 2023 Mar 3. | |
| 34498896 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Recovering Together | Dyads who are randomly assigned, via RedCap randomization, to the Recovering Together program received any usual clinic care as determined by their clinicians. Additionally, dyads were invited to participate in 6 30-minute skills sessions. All sessions included both pt and cg. A clinical psychologist delivered the majority of sessions while the PI delivered at least 10% of the sessions. The main intervention goal was to provide dyads with resiliency and interpersonal communication skills necessary to optimize their recovery and reduce emotional distress and PTS. Recovering Together: The intervention taught resiliency skills (mindfulness, coping, interpersonal communication, etc) within 2 in person sessions at hospitalization and 4 live video sessions after discharge. Both patient and caregiver participated in all sessions |
| FG001 | Health Education | Dyads who were randomly assigned, via RedCap randomization, to the control condition received an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that were hypothesized to be responsible for improvement in emotional distress. These sessions included health education content on self-care, including sleep, diet, movement, and exercise. The control entailed 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge. Both patient and caregiver participated in all sessions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Total number of participants (patients and caregivers) who completed >=1 intervention or control session were analyzed and included in baseline population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Recovering Together: Patients | Participants who are randomly assigned to the Recovering Together program received any usual clinic care as determined by their clinicians. Additionally, participants were invited to participate in 6 30-minute skills sessions. All sessions included both pt and cg. A clinical psychologist delivered the majority of sessions while the PI delivered at least 10% of the sessions. The main intervention goal was to provide dyads with resiliency and interpersonal communication skills necessary to optimize their recovery and reduce emotional distress and PTS. Recovering Together: The intervention taught resiliency skills (mindfulness, coping, interpersonal communication, etc) within 2 in person sessions at hospitalization and 4 live video sessions after discharge. Both patient and caregiver participated in all sessions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Total number of participants (patients and caregivers) who completed >=1 intervention or control session were analyzed and included in baseline population. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Recruitment (Ability to Recruit Dyads) | Feasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled | Posted | Count of Participants | Participants | Baseline |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Recovering Together: Patients | Patients who are randomly assigned to the Recovering Together program will receive any usual clinic care as determined by their clinicians. Additionally, patients and their caregivers will be invited to participate in 6 30-minute skills sessions. All sessions will include both pt and cg. A clinical psychologist will deliver the majority of sessions while the PI will deliver at least 10% of the sessions. The main intervention goal is to provide dyads with resiliency and interpersonal communication skills necessary to optimize their recovery and reduce emotional distress and PTS. Recovering Together: The intervention will teach resiliency skills (mindfulness, coping, interpersonal communication, etc) within 2 in person sessions at hospitalization and 4 live video sessions after discharge. Both patient and caregiver will participate in all sessions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana-Maria Vranceanu | Massachusetts General Hospital | 6178931664 | avranceanu@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 6, 2019 | Aug 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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|
| Post Traumatic Checklist | The PTSD CheckList - Civilian Version measures symptoms of post traumatic stress and determines diagnoses. Scores range from 17-85. Higher scores indicate more severe stress. | baseline to posttest to 3 months follow up |
| Measures of Coping Style Part A | The MOCS-A measures various coping strategies such as relaxation or adaptive thinking. Scores range from 0 to 52, and higher scores indicate greater self-perceived proficiency with these skills. | baseline to posttest to 3 months follow up |
| Cognitive and Affective Mindfulness Scale Revised | Measures mindfulness skills used in daily life. The scale ranges from 12 to 48 with higher scores indicating higher mindfulness. | baseline to post test to 3 months follow up |
| Dyadic Relationship Scale | The Dyadic Relationship Scale (DRS) has 2 sub scales that assess dyadic strains and dyadic positive interaction. Scales on each sub scale range from 1 to 4, with higher scores indicating great severity of the relevant construct. | Baseline, post treatment, 3-month follow-up |
| Bannon SM, Cornelius T, Gates MV, Lester E, Mace RA, Popok P, Macklin EA, Rosand J, Vranceanu AM. Emotional distress in neuro-ICU survivor-caregiver dyads: The recovering together randomized clinical trial. Health Psychol. 2022 Apr;41(4):268-277. doi: 10.1037/hea0001102. Epub 2021 Sep 9. |
| 33052404 | Derived | Vranceanu AM, Bannon S, Mace R, Lester E, Meyers E, Gates M, Popok P, Lin A, Salgueiro D, Tehan T, Macklin E, Rosand J. Feasibility and Efficacy of a Resiliency Intervention for the Prevention of Chronic Emotional Distress Among Survivor-Caregiver Dyads Admitted to the Neuroscience Intensive Care Unit: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020807. doi: 10.1001/jamanetworkopen.2020.20807. |
| BG001 | Recovering Together: Caregivers | Participants who are randomly assigned to the Recovering Together program received any usual clinic care as determined by their clinicians. Additionally, participants were invited to participate in 6 30-minute skills sessions. All sessions included both pt and cg. A clinical psychologist delivered the majority of sessions while the PI delivered at least 10% of the sessions. The main intervention goal was to provide dyads with resiliency and interpersonal communication skills necessary to optimize their recovery and reduce emotional distress and PTS. Recovering Together: The intervention taught resiliency skills (mindfulness, coping, interpersonal communication, etc) within 2 in person sessions at hospitalization and 4 live video sessions after discharge. Both patient and caregiver participated in all sessions |
| BG002 | Health Education: Patients | Participants randomly assigned to the control condition received an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that were hypothesized to be responsible for improvement in emotional distress. The control entailed 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge. All sessions included both pt and cg. |
| BG003 | Health Education: Caregivers | Participants randomly assigned to the control condition received an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that were hypothesized to be responsible for improvement in emotional distress. The control entailed 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge. All sessions included both pt and cg. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Measure Analysis Population Description: Total number of participants (patients and caregivers) who completed >=1 intervention or control session were analyzed and included in baseline population. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Total number of participants (patients and caregivers) who completed >=1 intervention or control session were analyzed and included in baseline population. | Count of Participants | Participants |
|
| Employment status | Count of Participants | Participants |
|
|
| Primary | Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads) | We will report number of sessions completed by each dyad. We will report any technical difficulties with live video delivery | Number of dyads who started RT who had at least 1 member complete post treatment assessment | Posted | Number | dyads | Feasibility of program delivery will be measured at 6 weeks |
|
|
|
| Primary | Credibility and Expectancy Questionnaire | This measure will assess participants' belief that the intervention (or control) will be helpful. The score range is 3-27. Higher scores mean higher perception of credibility or expectancy. | Score on Credibility and Expectancy Questionnaire | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Client Satisfaction Questionnaire | This measure will assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction. | Score on Client Satisfaction Questionnaire | Posted | Mean | Standard Deviation | score on a scale | post intervention (6 weeks after baseline) |
|
|
|
| Secondary | Hospital Anxiety and Depression Scale | Measures symptoms of emotional distress and estimates diagnoses. The scale has 14 items, 7 assess anxiety and 7 depression. Scores range from 0-21 on each subscale, wtih higher scores indicating more symptoms. Scores greater than 8 indicate clinically significant symptoms. | Posted | Mean | Standard Deviation | score on a scale | baseline to posttest to 3 months follow up |
|
|
|
| Secondary | Post Traumatic Checklist | The PTSD CheckList - Civilian Version measures symptoms of post traumatic stress and determines diagnoses. Scores range from 17-85. Higher scores indicate more severe stress. | Posted | Mean | Standard Deviation | score on a scale | baseline to posttest to 3 months follow up |
|
|
|
| Secondary | Measures of Coping Style Part A | The MOCS-A measures various coping strategies such as relaxation or adaptive thinking. Scores range from 0 to 52, and higher scores indicate greater self-perceived proficiency with these skills. | Posted | Mean | Standard Deviation | score on a scale | baseline to posttest to 3 months follow up |
|
|
|
| Secondary | Cognitive and Affective Mindfulness Scale Revised | Measures mindfulness skills used in daily life. The scale ranges from 12 to 48 with higher scores indicating higher mindfulness. | Posted | Mean | Standard Deviation | score on a scale | baseline to post test to 3 months follow up |
|
|
|
| Secondary | Dyadic Relationship Scale | The Dyadic Relationship Scale (DRS) has 2 sub scales that assess dyadic strains and dyadic positive interaction. Scales on each sub scale range from 1 to 4, with higher scores indicating great severity of the relevant construct. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post treatment, 3-month follow-up |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Recovering Together: Caregivers | Caregivers who are randomly assigned to the Recovering Together program will receive any usual clinic care as determined by their clinicians. Additionally, caregivers and their patients will be invited to participate in 6 30-minute skills sessions. All sessions will include both pt and cg. A clinical psychologist will deliver the majority of sessions while the PI will deliver at least 10% of the sessions. The main intervention goal is to provide dyads with resiliency and interpersonal communication skills necessary to optimize their recovery and reduce emotional distress and PTS. Recovering Together: The intervention will teach resiliency skills (mindfulness, coping, interpersonal communication, etc) within 2 in person sessions at hospitalization and 4 live video sessions after discharge. Both patient and caregiver will participate in all sessions | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Health Education: Patients | Patients randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG003 | Health Education: Caregivers | Caregivers randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge. | 0 | 31 | 0 | 31 | 0 | 31 |
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| Posttreatment: depression |
|
| 3-month follow-up: depression |
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| Baseline: anxiety |
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| Posttreatment: anxiety |
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| 3-month follow-up: anxiety |
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| Posttreatment |
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| 3-month follow-up |
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| Posttest |
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| 3-month follow-up |
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| Posttreatment |
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| 3-month follow-up |
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| Dyadic strain: posttreatment |
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| Dyadic strain: 3-month follow-up |
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| Positive interactions: baseline |
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| Positive interactions: posttreatment |
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| Positive interactions: 3-month follow-up |
|