Anxiety, Burden, Dependency, Caregiver
Conditions
Brief summary
The Time for Living & Caring (TLC) intervention is an online, self-administered intervention, with the purpose of providing informal family caregivers with resources, support, and education to maximize the benefit of their respite time-use (respite is defined as planned time away from caregiving; it can be provided by a formal service provider or informal arrangements within families/networks). The study will use a full-powered pilot sample (anticipated n=150; actual n=166) and a randomized waitlist control design to examine feasibility and initial efficacy of the TLC intervention.
Detailed description
The purpose of this study is to redevelop the Time for Living and Caring (TLC) intervention, in which dementia caregivers are taught strategies to assess and identify ways to spend upcoming periods of respite time, to a fully online, self-administered virtual coaching format, and then to pilot-test the new TLC intervention for feasibility and efficacy. Aim 1 is to modify, adapt, and refine the existing intervention modules, utilizing a community-engaged design process where stakeholders (i.e., current or former caregivers, diverse community leaders, and respite providers) will work as consultants alongside the research, technical, and creative teams to develop and provide feedback on the TLC prototypes. The primary endpoint of this phase of the study is a fully-developed, tested, and ready-to-launch web-based intervention. Aim 2 is to conduct a pilot test with dementia caregivers who are currently using respite, using a full powered pilot sample and a randomized waitlist-control experimental design where participants are exposed to the redeveloped TLC intervention for 8 weeks and will provide assessments of daily respite use, respite time-use satisfaction, and wellbeing. These pilot data will be used to assess feasibility and to explore hypotheses regarding the potential efficacy of the intervention as well as the mechanism - time-use satisfaction -underlying the intervention's effect on wellbeing. \*\*Aim 2 uses a clinical trial methodology, and is therefore the part of the study that is described in detail here \*\* Aim 3 is intended to explore future implementation with respite providers, as yet another assessment of the intervention's feasibility. We will host webinars to demonstrate the features and functionality of the TLC intervention. We will then ask providers for feedback on their likelihood of implementation and barriers to using TLC with their clients. Together, these three aims represent a comprehensive approach to Stage 1 behavioral intervention research activities, with the overall goal of (re)developing an intervention that is useful to dementia caregivers and is scalable to real world applications. Each aim has a separate sample and study design. Aim 1 Sample & Design: a dozen community stakeholders, consisting of current and former AD/ADRD caregivers, respite providers, and community leaders that represent diverse local populations. These participants will be considered consultants (not human subjects), per IRB. They are providing feedback and advice to the research team and technical designers in the creation and translation of the TLC intervention tools to a self-administered, app-delivered intervention. Aim 2 Sample & Design: a total of 150 respite-using AD/ADRD caregivers. This is the sample that is participating in the clinical trial. \*\* eligibility, measures, study design for this phase of the overall project are described in greater detail here \*\* Aim 3 Sample & Design: a minimum of 100 respite providers, located anywhere in the US, such as staff from home health agencies, adult day care centers, area agencies on aging, long term care communities, hospices, hospitals, etc. Eligibility is based on their interest and willingness to learn more about the TLC intervention. This sample will provide feedback on the features and functionality of the TLC intervention, as well as specific advice on how it could serve their clients and be disseminated in the future. This is human subjects research, but is not part of the clinical trial.
Interventions
BEHAVIORALTime for Living and Caring (TLC)
Time for Living & Caring (TLC) is an online, self-administered intervention. It includes three types of modules: 1) virtual coaching module (defined as a series of prompts, reminders, and suggestions that guide caregivers through assessment, goal setting, and goal review activities) to monitor respite time-use and time-use goals, 2) an interactive calendar that can be used to schedule and track respite time, 3) resource pages (including links, printable forms, video guides) that provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?.
Sponsors
National Institute on Aging (NIA)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This study uses a full-powered pilot sample (n=150) and a randomized waitlist control design to examine feasibility and initial efficacy of the TLC intervention. After an initial orientation/control period (4 weeks), group A will receive access to the TLC intervention for 8 weeks, followed by an optional 8-week control period where they can continue to use the TLC intervention if they choose. After the initial 4-week orientation period, Group B will receive 8 weeks of waitlist (no treatment) control, followed by access to the TLC intervention for 8 weeks. Primary outcomes (defined as anxiety, caregiver burden) will be assessed by electronically delivered surveys every 4 weeks; respite time-use and time-use satisfaction will be assessed using ecological momentary analysis for each respite period taken during the 20-week study period; feasibility will be assessed using fixed-choice and open-ended survey questions collected post-intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* caregivers to persons with Alzheimer's Disease or Related Dementia (AD/ADRD) (self-identified) * use formal or informal respite for at least 4 hours per week. * primary caregiver (self-identified) * co-residing with the care recipient * 18 years or older AND * able to read and write in English.
Exclusion criteria
* caregivers to persons with disability or chronic condition, and not Alzheimer's Disease and Related Dementia (AD/ADRD) * caregivers who do not use respite for at least 4 hours per week * noncoresidential caregivers * younger than 18 years * not able to read and write in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form | Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B | Anxiety was measured with the PROMIS Anxiety short-form questionnaire for adults, a self-report, 8-item additive scale that standardizes the distribution of anxiety-related symptoms (T-score) on a population-distribution with a mean of 50 and standard deviation of 10: During the past 7 days, I felt nervous, anxious, fearful, uneasy, tense, worried, unable to focus on anything other than my anxiety, felt like I needed help with my anxiety each assessed with a five-category response (never, rarely, sometimes, often, always). Higher scores indicate a higher level of anxiety. |
| Caregiver Burden Score, as Measured by Caregiver Burden Inventory | Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B | Self-report multi-item index (24 items; range 0-96). Lower scores indicate lower levels of caregiver burden. Higher scores indicate higher levels of perceived burden associated with caregiving tasks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respite Time-Use (in Hours Per Week) | Pre-Intervention (baseline, week 1) and Post-Intervention (week-16) for both Group A and Group B | Participants were asked to self-report number of hours they typically receive respite in a typical week. The following survey question and description were asked to all participants On average, how many hours of respite do you get in a typical week? These would be hours that you can completely turn-off your caregiving responsibilities, while the needs and safety of your family member are not your primary responsibility. |
| Respite Satisfaction: Count (%) of Participants Who Agreed or Strongly Agreed With the Statement I am Happy With What I Choose to do During Respite | Pre-Intervention (baseline, week 1) and Post-Intervention (week 16) for both Group A and Group B | Self-report single item measure, assessing partcipants' perceived level of satisfaction with their respite time and time use. Respondents were asked about their level of agreement with the following statement: I am happy with what I choose to do during my respite time. Responses were recorded on a five-point Likert scale with strongly disagree=1 and strongly agree 5. This variable is dichotomized, showing the count (and percentage) of the sample that responded with agree or stongly agree. This self-report assessment was only collected at baseline (pre-intervention) and at time 16 (post-intervention) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms, as Measured by the PROMIS Depression Scale (Vol 1 Short Form) | Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B | Self-report multi-item index (8-items, additive), with higher scores indicating greater presence and frequency of depressive symptoms; scores are standardized to a distribution of depression-related symptoms on a population-distribution with a mean of 50 and standard deviation of 10 (T-score). Participants self-reported to the following survey questions: During the past 7 days, I felt worthless, helpless, depressed, hopeless, like a failure, unhappy, that I had nothing to look forward to, that nothing could cheer me up, each assessed with a five-category response (never, rarely, sometimes, often, always). Higher scores indicate a higher level of depressive symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment With Follow-up (Group A) Group A received access to the full Time for Living & Caring (TLC) intervention for 8 weeks (calendar + coaching + resources), followed by an 8-week maintenance period where they could continue to use the TLC intervention. The TLC intervention turned off after 16 weeks of exposure for all participants. | 83 |
| Waitlist Control (Group A) Group B received 8 weeks of waitlist control (minimal treatment - calendar only) , followed by access to the full Time for Living & Caring (TLC) intervention for an additional 8 weeks (calendar + coaching + resources). The TLC intervention turned off after 16 weeks of exposure for all participants. | 83 |
| Total | 166 |
Baseline characteristics
| Characteristic | Waitlist Control (Group A) | Total | Treatment With Follow-up (Group A) |
|---|---|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 12.9 | 61.7 years STANDARD_DEVIATION 13 | 60.8 years STANDARD_DEVIATION 13.1 |
| Annual Income $100,000 to $149,999 | 11 Participants | 28 Participants | 17 Participants |
| Annual Income $10,000 to $19,999 | 0 Participants | 2 Participants | 2 Participants |
| Annual Income $150,000 or more | 13 Participants | 17 Participants | 4 Participants |
| Annual Income $20,000 to $29,999 | 7 Participants | 13 Participants | 6 Participants |
| Annual Income $30,000 to $39,999 | 1 Participants | 8 Participants | 7 Participants |
| Annual Income $40,000 to $49,999 | 8 Participants | 16 Participants | 8 Participants |
| Annual Income $50,000 to $59,999 | 12 Participants | 22 Participants | 10 Participants |
| Annual Income $60,000 to $69,999 | 8 Participants | 20 Participants | 12 Participants |
| Annual Income $70,000 to $79,999 | 8 Participants | 11 Participants | 3 Participants |
| Annual Income $80,000 to $89,999 | 6 Participants | 11 Participants | 5 Participants |
| Annual Income $90,000 to $99,999 | 4 Participants | 11 Participants | 7 Participants |
| Annual Income Unknown or Not Reported | 5 Participants | 7 Participants | 2 Participants |
| Education Completed College or University Degree | 24 Participants | 46 Participants | 22 Participants |
| Education Completed High School Graduate | 4 Participants | 8 Participants | 4 Participants |
| Education Completed Postgraduate or Professional Degree | 22 Participants | 43 Participants | 21 Participants |
| Education Completed Some College, Associates Degree, and/or Vocational or Technical School | 27 Participants | 60 Participants | 33 Participants |
| Education Completed Some High School | 1 Participants | 3 Participants | 2 Participants |
| Education Completed Unknown or Not Reported | 5 Participants | 6 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 9 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants | 150 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 7 Participants | 0 Participants |
| Marital Status Divorced | 4 Participants | 12 Participants | 8 Participants |
| Marital Status Living with Partner | 2 Participants | 5 Participants | 3 Participants |
| Marital Status Married | 69 Participants | 134 Participants | 65 Participants |
| Marital Status Never Married | 2 Participants | 7 Participants | 5 Participants |
| Marital Status Unknown or Not Reported | 6 Participants | 6 Participants | 0 Participants |
| Marital Status Widowed | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 8 Participants | 0 Participants |
| Race (NIH/OMB) White | 66 Participants | 137 Participants | 71 Participants |
| Region of Enrollment United States | 83 participants | 166 participants | 83 participants |
| Sex: Female, Male Female | 65 Participants | 131 Participants | 66 Participants |
| Sex: Female, Male Male | 18 Participants | 35 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 83 | 0 / 83 |
| other Total, other adverse events | 0 / 83 | 0 / 83 |
| serious Total, serious adverse events | 0 / 83 | 0 / 83 |
Outcome results
Primary
Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form
Anxiety was measured with the PROMIS Anxiety short-form questionnaire for adults, a self-report, 8-item additive scale that standardizes the distribution of anxiety-related symptoms (T-score) on a population-distribution with a mean of 50 and standard deviation of 10: During the past 7 days, I felt nervous, anxious, fearful, uneasy, tense, worried, unable to focus on anything other than my anxiety, felt like I needed help with my anxiety each assessed with a five-category response (never, rarely, sometimes, often, always). Higher scores indicate a higher level of anxiety.
Time frame: Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B
Population: Three enrolled participants were excluded from this analysis due to missing baseline data (i.e., 163 person out of 166 enrolled have data).If a participant was missing more than 30% of the items (i.e., 2 or more items on the anxiety questionnaire), the scale score was coded as missing. Under these criteria, the full TLC sample has a calculated score for anxiety.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment With Follow-up (Group A) | Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form | T0 - baseline, Pre-Intervention | 55.51 T-score |
| Treatment With Follow-up (Group A) | Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form | T4 | 56.75 T-score |
| Treatment With Follow-up (Group A) | Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form | T8 | 56.39 T-score |
| Treatment With Follow-up (Group A) | Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form | T12 | 56.92 T-score |
| Treatment With Follow-up (Group A) | Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form | T16 - Post Intervention | 56.54 T-score |
| Treatment With Follow-up (Group A) | Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form | T20 - Follow-up | 58.15 T-score |
| Wait-List / Control Treatment With Follow-up (Group B) | Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form | T16 - Post Intervention | 52.75 T-score |
| Wait-List / Control Treatment With Follow-up (Group B) | Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form | T0 - baseline, Pre-Intervention | 53.93 T-score |
| Wait-List / Control Treatment With Follow-up (Group B) | Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form | T12 | 54.20 T-score |
| Wait-List / Control Treatment With Follow-up (Group B) | Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form | T4 | 57.35 T-score |
| Wait-List / Control Treatment With Follow-up (Group B) | Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form | T20 - Follow-up | 55.73 T-score |
| Wait-List / Control Treatment With Follow-up (Group B) | Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form | T8 | 56.99 T-score |
Primary
Caregiver Burden Score, as Measured by Caregiver Burden Inventory
Self-report multi-item index (24 items; range 0-96). Lower scores indicate lower levels of caregiver burden. Higher scores indicate higher levels of perceived burden associated with caregiving tasks.
Time frame: Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B
Population: Three enrolled participants were excluded from analysis due to missing baseline data.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment With Follow-up (Group A) | Caregiver Burden Score, as Measured by Caregiver Burden Inventory | T0 - Baseline | 45.94 score on a scale |
| Treatment With Follow-up (Group A) | Caregiver Burden Score, as Measured by Caregiver Burden Inventory | T4 | 45.33 score on a scale |
| Treatment With Follow-up (Group A) | Caregiver Burden Score, as Measured by Caregiver Burden Inventory | T8 - mid intervention | 45.02 score on a scale |
| Treatment With Follow-up (Group A) | Caregiver Burden Score, as Measured by Caregiver Burden Inventory | T12 | 45.72 score on a scale |
| Treatment With Follow-up (Group A) | Caregiver Burden Score, as Measured by Caregiver Burden Inventory | T16 - Post intervention | 49.91 score on a scale |
| Treatment With Follow-up (Group A) | Caregiver Burden Score, as Measured by Caregiver Burden Inventory | T20 - follow up | 50.09 score on a scale |
| Wait-List / Control Treatment With Follow-up (Group B) | Caregiver Burden Score, as Measured by Caregiver Burden Inventory | T16 - Post intervention | 42.05 score on a scale |
| Wait-List / Control Treatment With Follow-up (Group B) | Caregiver Burden Score, as Measured by Caregiver Burden Inventory | T0 - Baseline | 46.10 score on a scale |
| Wait-List / Control Treatment With Follow-up (Group B) | Caregiver Burden Score, as Measured by Caregiver Burden Inventory | T12 | 40.80 score on a scale |
| Wait-List / Control Treatment With Follow-up (Group B) | Caregiver Burden Score, as Measured by Caregiver Burden Inventory | T4 | 43.22 score on a scale |
| Wait-List / Control Treatment With Follow-up (Group B) | Caregiver Burden Score, as Measured by Caregiver Burden Inventory | T20 - follow up | 43.23 score on a scale |
| Wait-List / Control Treatment With Follow-up (Group B) | Caregiver Burden Score, as Measured by Caregiver Burden Inventory | T8 - mid intervention | 43.37 score on a scale |
Secondary
Respite Satisfaction: Count (%) of Participants Who Agreed or Strongly Agreed With the Statement I am Happy With What I Choose to do During Respite
Self-report single item measure, assessing partcipants' perceived level of satisfaction with their respite time and time use. Respondents were asked about their level of agreement with the following statement: I am happy with what I choose to do during my respite time. Responses were recorded on a five-point Likert scale with strongly disagree=1 and strongly agree 5. This variable is dichotomized, showing the count (and percentage) of the sample that responded with agree or stongly agree. This self-report assessment was only collected at baseline (pre-intervention) and at time 16 (post-intervention)
Time frame: Pre-Intervention (baseline, week 1) and Post-Intervention (week 16) for both Group A and Group B
Population: Three enrolled participants were excluded from this analysis due to missing baseline data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Follow-up (Group A) | Respite Satisfaction: Count (%) of Participants Who Agreed or Strongly Agreed With the Statement I am Happy With What I Choose to do During Respite | Pre Intervention (baseline, week 1) | 38 Participants |
| Treatment With Follow-up (Group A) | Respite Satisfaction: Count (%) of Participants Who Agreed or Strongly Agreed With the Statement I am Happy With What I Choose to do During Respite | Post Intervention (week 16) | 61 Participants |
| Wait-List / Control Treatment With Follow-up (Group B) | Respite Satisfaction: Count (%) of Participants Who Agreed or Strongly Agreed With the Statement I am Happy With What I Choose to do During Respite | Pre Intervention (baseline, week 1) | 34 Participants |
| Wait-List / Control Treatment With Follow-up (Group B) | Respite Satisfaction: Count (%) of Participants Who Agreed or Strongly Agreed With the Statement I am Happy With What I Choose to do During Respite | Post Intervention (week 16) | 59 Participants |
Secondary
Respite Time-Use (in Hours Per Week)
Participants were asked to self-report number of hours they typically receive respite in a typical week. The following survey question and description were asked to all participants On average, how many hours of respite do you get in a typical week? These would be hours that you can completely turn-off your caregiving responsibilities, while the needs and safety of your family member are not your primary responsibility.
Time frame: Pre-Intervention (baseline, week 1) and Post-Intervention (week-16) for both Group A and Group B
Population: Three enrolled participants were excluded from this analysis due to missing baseline data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment With Follow-up (Group A) | Respite Time-Use (in Hours Per Week) | Pre Intervention | 8.77 number of hours (self-reported) | Standard Deviation 8.89 |
| Treatment With Follow-up (Group A) | Respite Time-Use (in Hours Per Week) | Post Intervention | 13.44 number of hours (self-reported) | Standard Deviation 12.64 |
| Wait-List / Control Treatment With Follow-up (Group B) | Respite Time-Use (in Hours Per Week) | Pre Intervention | 7.81 number of hours (self-reported) | Standard Deviation 11.01 |
| Wait-List / Control Treatment With Follow-up (Group B) | Respite Time-Use (in Hours Per Week) | Post Intervention | 13.11 number of hours (self-reported) | Standard Deviation 10.82 |
Other Pre-specified
Depressive Symptoms, as Measured by the PROMIS Depression Scale (Vol 1 Short Form)
Self-report multi-item index (8-items, additive), with higher scores indicating greater presence and frequency of depressive symptoms; scores are standardized to a distribution of depression-related symptoms on a population-distribution with a mean of 50 and standard deviation of 10 (T-score). Participants self-reported to the following survey questions: During the past 7 days, I felt worthless, helpless, depressed, hopeless, like a failure, unhappy, that I had nothing to look forward to, that nothing could cheer me up, each assessed with a five-category response (never, rarely, sometimes, often, always). Higher scores indicate a higher level of depressive symptoms.
Time frame: Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B
Population: Three enrolled participants were excluded from this analysis due to missing baseline data. If a participant was missing more than 30% of the items (i.e., 2 or more items on the depression questionnaire), the scale score was coded as missing. Under these criteria, the full TLC sample has a calculated score for depression.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment With Follow-up (Group A) | Depressive Symptoms, as Measured by the PROMIS Depression Scale (Vol 1 Short Form) | T0 - preintervention | 54.34 T-score |
| Treatment With Follow-up (Group A) | Depressive Symptoms, as Measured by the PROMIS Depression Scale (Vol 1 Short Form) | T4 | 55.81 T-score |
| Treatment With Follow-up (Group A) | Depressive Symptoms, as Measured by the PROMIS Depression Scale (Vol 1 Short Form) | T8 - mid intervention | 54.68 T-score |
| Treatment With Follow-up (Group A) | Depressive Symptoms, as Measured by the PROMIS Depression Scale (Vol 1 Short Form) | T12 | 55.73 T-score |
| Treatment With Follow-up (Group A) | Depressive Symptoms, as Measured by the PROMIS Depression Scale (Vol 1 Short Form) | T16 - post-intervention | 54.75 T-score |
| Treatment With Follow-up (Group A) | Depressive Symptoms, as Measured by the PROMIS Depression Scale (Vol 1 Short Form) | T20 - follow-up | 56.25 T-score |
| Wait-List / Control Treatment With Follow-up (Group B) | Depressive Symptoms, as Measured by the PROMIS Depression Scale (Vol 1 Short Form) | T16 - post-intervention | 52.52 T-score |
| Wait-List / Control Treatment With Follow-up (Group B) | Depressive Symptoms, as Measured by the PROMIS Depression Scale (Vol 1 Short Form) | T0 - preintervention | 53.92 T-score |
| Wait-List / Control Treatment With Follow-up (Group B) | Depressive Symptoms, as Measured by the PROMIS Depression Scale (Vol 1 Short Form) | T12 | 53.19 T-score |
| Wait-List / Control Treatment With Follow-up (Group B) | Depressive Symptoms, as Measured by the PROMIS Depression Scale (Vol 1 Short Form) | T4 | 55.18 T-score |
| Wait-List / Control Treatment With Follow-up (Group B) | Depressive Symptoms, as Measured by the PROMIS Depression Scale (Vol 1 Short Form) | T20 - follow-up | 53.85 T-score |
| Wait-List / Control Treatment With Follow-up (Group B) | Depressive Symptoms, as Measured by the PROMIS Depression Scale (Vol 1 Short Form) | T8 - mid intervention | 54.38 T-score |