Acute Brain Injuries
Conditions
Keywords
Psychiatry, Dyads, Patients, Caregivers, Psychosocial
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALRecovering 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
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients, 18 years or older * English fluency and literacy * Access to high speed internet for video sessions * Patient with an informal cg (family or friend who provides unpaid care) available and willing to participate * Hospitalized with an acute brain injury within 1-2 days when first approached, OR the primary caregiver of a patient currently admitted with an acute brain injury * Either patient or caregiver within the dyads screens in for depression, anxiety, and/or PTSD
Exclusion criteria
* Permanent or severe cognitive impairment severe enough to impede participation - This will be determined by nurses through an assessment conducted as part of usual care (MMSE). * Dyads where the patient is anticipated to die or to never be able to participate due to medical sequelae.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Client Satisfaction Questionnaire | post intervention (6 weeks after baseline) | This measure will assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction. |
| Feasibility of Recruitment (Ability to Recruit Dyads) | Baseline | Feasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled |
| Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads) | Feasibility of program delivery will be measured at 6 weeks | We will report number of sessions completed by each dyad. We will report any technical difficulties with live video delivery |
| Credibility and Expectancy Questionnaire | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyadic Relationship Scale | Baseline, post treatment, 3-month follow-up | 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. |
| Measures of Coping Style Part A | baseline to posttest to 3 months follow up | 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. |
| Cognitive and Affective Mindfulness Scale Revised | baseline to post test to 3 months follow up | Measures mindfulness skills used in daily life. The scale ranges from 12 to 48 with higher scores indicating higher mindfulness. |
| Hospital Anxiety and Depression Scale | baseline to posttest to 3 months follow up | 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. |
| Post Traumatic Checklist | baseline to posttest to 3 months follow up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 29 |
| 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 | 29 |
| 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. | 29 |
| 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. | 29 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Health Education: Caregivers | Health Education: Patients | Recovering Together: Caregivers | Recovering Together: Patients |
|---|---|---|---|---|---|
| Age, Continuous | 50.9 Years STANDARD_DEVIATION 15.5 | 52.1 Years STANDARD_DEVIATION 14.9 | 50.1 Years STANDARD_DEVIATION 16.4 | 52.4 Years STANDARD_DEVIATION 14.3 | 49.3 Years STANDARD_DEVIATION 16.7 |
| Employment status Employed full-time | 62 Participants | 18 Participants | 12 Participants | 14 Participants | 18 Participants |
| Employment status Employed part-time | 7 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants |
| Employment status Full-time or part-time student | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants |
| Employment status Homemaker | 5 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants |
| Employment status Other | 15 Participants | 2 Participants | 6 Participants | 3 Participants | 4 Participants |
| Employment status Retired | 23 Participants | 4 Participants | 8 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 3 Participants | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 4 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 94 Participants | 20 Participants | 24 Participants | 25 Participants | 25 Participants |
| Sex: Female, Male Female | 60 Participants | 17 Participants | 12 Participants | 22 Participants | 9 Participants |
| Sex: Female, Male Male | 56 Participants | 12 Participants | 17 Participants | 7 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 31 | 0 / 31 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 31 | 0 / 31 |
Outcome results
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.
Time frame: post intervention (6 weeks after baseline)
Population: Score on Client Satisfaction Questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Participants | Client Satisfaction Questionnaire | 10.65 score on a scale | Standard Deviation 1.18 |
| Health Education | Client Satisfaction Questionnaire | 9.87 score on a scale | Standard Deviation 2.7 |
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.
Time frame: Baseline
Population: Score on Credibility and Expectancy Questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Credibility and Expectancy Questionnaire | Credibility and Expectancy Questionnaire; credibility subscale | 22.0 score on a scale | Standard Deviation 4.4 |
| Eligible Participants | Credibility and Expectancy Questionnaire | Credibility and Expectancy Questionnaire; expectancy subscale | 19.0 score on a scale | Standard Deviation 5.2 |
| Health Education | Credibility and Expectancy Questionnaire | Credibility and Expectancy Questionnaire; credibility subscale | 20.3 score on a scale | Standard Deviation 4.8 |
| Health Education | Credibility and Expectancy Questionnaire | Credibility and Expectancy Questionnaire; expectancy subscale | 19.5 score on a scale | Standard Deviation 5.6 |
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
Time frame: Feasibility of program delivery will be measured at 6 weeks
Population: Number of dyads who started RT who had at least 1 member complete post treatment assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eligible Participants | Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads) | Number of dyads who started RT who had at least 1 member complete post treatment assessment | 29 dyads |
| Eligible Participants | Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads) | Number of dyads who started RT who had neither member complete post treatment assessment | 1 dyads |
| Health Education | Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads) | Number of dyads who started RT who had neither member complete post treatment assessment | 0 dyads |
| Health Education | Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads) | Number of dyads who started RT who had at least 1 member complete post treatment assessment | 31 dyads |
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
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eligible Participants | Feasibility of Recruitment (Ability to Recruit Dyads) | Participants who enrolled and randomized | 122 Participants |
| Eligible Participants | Feasibility of Recruitment (Ability to Recruit Dyads) | Participants who declined | 40 Participants |
| Eligible Participants | Feasibility of Recruitment (Ability to Recruit Dyads) | Participants who enrolled and did not randomize | 4 Participants |
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.
Time frame: baseline to post test to 3 months follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Cognitive and Affective Mindfulness Scale Revised | 3-month follow-up | 35.5 score on a scale | Standard Deviation 7.9 |
| Eligible Participants | Cognitive and Affective Mindfulness Scale Revised | Posttreatment | 36.7 score on a scale | Standard Deviation 7.7 |
| Eligible Participants | Cognitive and Affective Mindfulness Scale Revised | Baseline | 34.2 score on a scale | Standard Deviation 7 |
| Health Education | Cognitive and Affective Mindfulness Scale Revised | 3-month follow-up | 36.3 score on a scale | Standard Deviation 7.5 |
| Health Education | Cognitive and Affective Mindfulness Scale Revised | Baseline | 34.6 score on a scale | Standard Deviation 5.8 |
| Health Education | Cognitive and Affective Mindfulness Scale Revised | Posttreatment | 36.3 score on a scale | Standard Deviation 6.5 |
| Health Education: Patients | Cognitive and Affective Mindfulness Scale Revised | Posttreatment | 35.0 score on a scale | Standard Deviation 10.7 |
| Health Education: Patients | Cognitive and Affective Mindfulness Scale Revised | 3-month follow-up | 32.3 score on a scale | Standard Deviation 9 |
| Health Education: Patients | Cognitive and Affective Mindfulness Scale Revised | Baseline | 35.1 score on a scale | Standard Deviation 7.8 |
| Health Education: Caregivers | Cognitive and Affective Mindfulness Scale Revised | Posttreatment | 36.7 score on a scale | Standard Deviation 8.5 |
| Health Education: Caregivers | Cognitive and Affective Mindfulness Scale Revised | 3-month follow-up | 33.3 score on a scale | Standard Deviation 9.4 |
| Health Education: Caregivers | Cognitive and Affective Mindfulness Scale Revised | Baseline | 36.4 score on a scale | Standard Deviation 7.6 |
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.
Time frame: Baseline, post treatment, 3-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Dyadic Relationship Scale | Positive interactions: posttreatment | 3.4 score on a scale | Standard Deviation 0.6 |
| Eligible Participants | Dyadic Relationship Scale | Dyadic strain: posttreatment | 1.6 score on a scale | Standard Deviation 0.6 |
| Eligible Participants | Dyadic Relationship Scale | Positive interactions: 3-month follow-up | 3.2 score on a scale | Standard Deviation 0.6 |
| Eligible Participants | Dyadic Relationship Scale | Dyadic strain: 3-month follow-up | 1.9 score on a scale | Standard Deviation 0.8 |
| Eligible Participants | Dyadic Relationship Scale | Positive interactions: baseline | 3.1 score on a scale | Standard Deviation 0.5 |
| Eligible Participants | Dyadic Relationship Scale | Dyadic strain: baseline | 2.0 score on a scale | Standard Deviation 0.8 |
| Health Education | Dyadic Relationship Scale | Dyadic strain: 3-month follow-up | 2.2 score on a scale | Standard Deviation 0.8 |
| Health Education | Dyadic Relationship Scale | Positive interactions: 3-month follow-up | 3.2 score on a scale | Standard Deviation 0.6 |
| Health Education | Dyadic Relationship Scale | Positive interactions: baseline | 3.0 score on a scale | Standard Deviation 0.5 |
| Health Education | Dyadic Relationship Scale | Positive interactions: posttreatment | 3.3 score on a scale | Standard Deviation 0.5 |
| Health Education | Dyadic Relationship Scale | Dyadic strain: posttreatment | 2.01 score on a scale | Standard Deviation 0.8 |
| Health Education | Dyadic Relationship Scale | Dyadic strain: baseline | 2.0 score on a scale | Standard Deviation 0.7 |
| Health Education: Patients | Dyadic Relationship Scale | Dyadic strain: posttreatment | 2.0 score on a scale | Standard Deviation 0.9 |
| Health Education: Patients | Dyadic Relationship Scale | Positive interactions: posttreatment | 2.97 score on a scale | Standard Deviation 0.77 |
| Health Education: Patients | Dyadic Relationship Scale | Positive interactions: 3-month follow-up | 2.82 score on a scale | Standard Deviation 0.67 |
| Health Education: Patients | Dyadic Relationship Scale | Positive interactions: baseline | 3.2 score on a scale | Standard Deviation 0.6 |
| Health Education: Patients | Dyadic Relationship Scale | Dyadic strain: 3-month follow-up | 2.0 score on a scale | Standard Deviation 0.9 |
| Health Education: Patients | Dyadic Relationship Scale | Dyadic strain: baseline | 2.0 score on a scale | Standard Deviation 0.78 |
| Health Education: Caregivers | Dyadic Relationship Scale | Dyadic strain: 3-month follow-up | 2.2 score on a scale | Standard Deviation 0.8 |
| Health Education: Caregivers | Dyadic Relationship Scale | Positive interactions: posttreatment | 3.2 score on a scale | Standard Deviation 0.7 |
| Health Education: Caregivers | Dyadic Relationship Scale | Dyadic strain: posttreatment | 2.1 score on a scale | Standard Deviation 0.9 |
| Health Education: Caregivers | Dyadic Relationship Scale | Positive interactions: 3-month follow-up | 3.0 score on a scale | Standard Deviation 0.7 |
| Health Education: Caregivers | Dyadic Relationship Scale | Dyadic strain: baseline | 1.8 score on a scale | Standard Deviation 0.7 |
| Health Education: Caregivers | Dyadic Relationship Scale | Positive interactions: baseline | 3.3 score on a scale | Standard Deviation 0.4 |
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.
Time frame: baseline to posttest to 3 months follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Hospital Anxiety and Depression Scale | Baseline: depression | 8.7 score on a scale | Standard Deviation 4.2 |
| Eligible Participants | Hospital Anxiety and Depression Scale | Posttreatment: depression | 4.0 score on a scale | Standard Deviation 4.1 |
| Eligible Participants | Hospital Anxiety and Depression Scale | 3-month follow-up: depression | 3.7 score on a scale | Standard Deviation 3.3 |
| Eligible Participants | Hospital Anxiety and Depression Scale | Baseline: anxiety | 11.1 score on a scale | Standard Deviation 4.7 |
| Eligible Participants | Hospital Anxiety and Depression Scale | Posttreatment: anxiety | 3.3 score on a scale | Standard Deviation 4.1 |
| Eligible Participants | Hospital Anxiety and Depression Scale | 3-month follow-up: anxiety | 4.7 score on a scale | Standard Deviation 4.8 |
| Health Education | Hospital Anxiety and Depression Scale | Baseline: depression | 7.8 score on a scale | Standard Deviation 2.7 |
| Health Education | Hospital Anxiety and Depression Scale | Baseline: anxiety | 13.2 score on a scale | Standard Deviation 3.9 |
| Health Education | Hospital Anxiety and Depression Scale | 3-month follow-up: depression | 2.42 score on a scale | Standard Deviation 2.58 |
| Health Education | Hospital Anxiety and Depression Scale | 3-month follow-up: anxiety | 5.3 score on a scale | Standard Deviation 3.8 |
| Health Education | Hospital Anxiety and Depression Scale | Posttreatment: depression | 3.28 score on a scale | Standard Deviation 3.37 |
| Health Education | Hospital Anxiety and Depression Scale | Posttreatment: anxiety | 6.0 score on a scale | Standard Deviation 3.8 |
| Health Education: Patients | Hospital Anxiety and Depression Scale | Posttreatment: depression | 7.2 score on a scale | Standard Deviation 3.7 |
| Health Education: Patients | Hospital Anxiety and Depression Scale | 3-month follow-up: depression | 7.7 score on a scale | Standard Deviation 5 |
| Health Education: Patients | Hospital Anxiety and Depression Scale | 3-month follow-up: anxiety | 8.9 score on a scale | Standard Deviation 6 |
| Health Education: Patients | Hospital Anxiety and Depression Scale | Baseline: anxiety | 6.3 score on a scale | Standard Deviation 4 |
| Health Education: Patients | Hospital Anxiety and Depression Scale | Baseline: depression | 7.1 score on a scale | Standard Deviation 4 |
| Health Education: Patients | Hospital Anxiety and Depression Scale | Posttreatment: anxiety | 8.5 score on a scale | Standard Deviation 5.2 |
| Health Education: Caregivers | Hospital Anxiety and Depression Scale | 3-month follow-up: anxiety | 9.62 score on a scale | Standard Deviation 5.02 |
| Health Education: Caregivers | Hospital Anxiety and Depression Scale | Posttreatment: anxiety | 8.1 score on a scale | Standard Deviation 6.1 |
| Health Education: Caregivers | Hospital Anxiety and Depression Scale | Posttreatment: depression | 6.1 score on a scale | Standard Deviation 5.4 |
| Health Education: Caregivers | Hospital Anxiety and Depression Scale | Baseline: depression | 4.8 score on a scale | Standard Deviation 3.8 |
| Health Education: Caregivers | Hospital Anxiety and Depression Scale | Baseline: anxiety | 7.0 score on a scale | Standard Deviation 4.7 |
| Health Education: Caregivers | Hospital Anxiety and Depression Scale | 3-month follow-up: depression | 7.27 score on a scale | Standard Deviation 5.28 |
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.
Time frame: baseline to posttest to 3 months follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Measures of Coping Style Part A | 3-month follow-up | 2.5 score on a scale | Standard Deviation 0.7 |
| Eligible Participants | Measures of Coping Style Part A | Baseline | 2.2 score on a scale | Standard Deviation 0.8 |
| Eligible Participants | Measures of Coping Style Part A | Posttest | 2.7 score on a scale | Standard Deviation 0.8 |
| Health Education | Measures of Coping Style Part A | Baseline | 2.3 score on a scale | Standard Deviation 0.6 |
| Health Education | Measures of Coping Style Part A | 3-month follow-up | 2.5 score on a scale | Standard Deviation 0.9 |
| Health Education | Measures of Coping Style Part A | Posttest | 2.6 score on a scale | Standard Deviation 1.1 |
| Health Education: Patients | Measures of Coping Style Part A | Posttest | 2.4 score on a scale | Standard Deviation 0.8 |
| Health Education: Patients | Measures of Coping Style Part A | Baseline | 2.6 score on a scale | Standard Deviation 0.9 |
| Health Education: Patients | Measures of Coping Style Part A | 3-month follow-up | 2.2 score on a scale | Standard Deviation 1 |
| Health Education: Caregivers | Measures of Coping Style Part A | Baseline | 2.5 score on a scale | Standard Deviation 0.9 |
| Health Education: Caregivers | Measures of Coping Style Part A | 3-month follow-up | 2.3 score on a scale | Standard Deviation 1 |
| Health Education: Caregivers | Measures of Coping Style Part A | Posttest | 2.4 score on a scale | Standard Deviation 1.2 |
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.
Time frame: baseline to posttest to 3 months follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | Post Traumatic Checklist | Baseline | 41.6 score on a scale | Standard Deviation 12.9 |
| Eligible Participants | Post Traumatic Checklist | 3-month follow-up | 28.2 score on a scale | Standard Deviation 10.1 |
| Eligible Participants | Post Traumatic Checklist | Posttreatment | 26.4 score on a scale | Standard Deviation 10.8 |
| Health Education | Post Traumatic Checklist | Baseline | 43.2 score on a scale | Standard Deviation 10.7 |
| Health Education | Post Traumatic Checklist | 3-month follow-up | 27.3 score on a scale | Standard Deviation 7.7 |
| Health Education | Post Traumatic Checklist | Posttreatment | 39.3 score on a scale | Standard Deviation 9.8 |
| Health Education: Patients | Post Traumatic Checklist | Posttreatment | 34.6 score on a scale | Standard Deviation 12.1 |
| Health Education: Patients | Post Traumatic Checklist | Baseline | 29.3 score on a scale | Standard Deviation 12.1 |
| Health Education: Patients | Post Traumatic Checklist | 3-month follow-up | 41.7 score on a scale | Standard Deviation 16 |
| Health Education: Caregivers | Post Traumatic Checklist | Baseline | 29.4 score on a scale | Standard Deviation 12 |
| Health Education: Caregivers | Post Traumatic Checklist | 3-month follow-up | 37.7 score on a scale | Standard Deviation 16.1 |
| Health Education: Caregivers | Post Traumatic Checklist | Posttreatment | 35.9 score on a scale | Standard Deviation 16.6 |