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A Problem Solving Intervention for Hospice Caregivers

A Problem Solving Intervention for Hospice Caregivers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03712410
Enrollment
523
Registered
2018-10-19
Start date
2018-10-23
Completion date
2022-12-30
Last updated
2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Generalized, Depression, Quality of Life

Brief summary

Hospice care is conceptualized as quality compassionate care for people facing a life-limiting illness, with services that cover clinical care, pain management, and emotional and spiritual support tailored to patients' and families' needs and preferences. Family members, spouses, friends or others who assume the unpaid or informal caregiving role are essential to the delivery of hospice services; however, stress and caregiver burden can negatively affect caregivers' morbidity and mortality. The emotional needs of individuals caring for dying persons at home are not well attended, and interventions aiming to provide support to hospice caregivers are notably lacking. The investigator team recently completed a study with 514 hospice caregivers to test a problem-solving therapy (PST) intervention tailored specifically for the hospice setting, entitled PISCES (Problem-solving Intervention to Support Caregivers in End of Life care Settings). The findings demonstrate that the PISCES intervention when delivered face to face was effective leading to statistically significant decrease in anxiety and increase in quality of life when compared to the other groups (video group and attention control). An additional lesson learned from that RCT study was that caregivers wanted to focus not only on specific problems or challenges, but also on recognizing the positive aspects of caregiving. This approach of positive reappraisal has been found to enhance problem solving interventions in other settings. The specific aims of this new study are: 1) to compare the effectiveness of the PISCES intervention when delivered face to face and when delivered in a hybrid platform (with the first session in person and remaining sessions via video) to hospice caregivers; 2) to compare the effectiveness of the PISCES intervention to the refined PISCES intervention (PISCESplus) that integrates positive reappraisal elements; 3) to assess caregivers' perceptions of and satisfaction with the PISCESplus intervention; and 4) to conduct a cost analysis of the three intervention groups.

Interventions

BEHAVIORALPISCES

The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
George Demiris, PhD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* enrolled as a family/informal caregiver of a hospice patient * 18 years or older * with access to a standard phone line or Internet and computer access at home * without functional hearing loss or with a hearing aid that allows the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver) * speak and read English, with at least a 6th-grade education

Exclusion criteria

* hearing or visual impairment that prohibits from conducting phone conversations or video conference sessions

Design outcomes

Primary

MeasureTime frameDescription
Table 2. Comparison of 4 Groupsfrom baseline to follow-up (prior to intervention-day 1 to post intervention-approx. day 30)Comparison of 4 groups Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more anxiety) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome (more distress) Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome (better quality of life)
Table 3. Comparison of Traditional PISCES vs. Online PISCESfrom baseline to follow-up (time point 1 is pre-intervention, i.e., day 0 and time point 2 is post-intervention, approx. day 30)Comparison of Traditional PISCES vs. Online PISCES Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more problems) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome
Table 4. Within-Group Comparison Baseline vs. Follow-upfrom baseline to follow-up (time point 1 is pre-intervention-day 0 and time point 2 is post-intervention-approx. day 30)Within-Group Comparison Baseline vs. Follow-up Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more problems) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome

Countries

United States

Participant flow

Participants by arm

ArmCount
Group 1 (PISCES-f2f)
Family caregivers will receive three sessions of the PISCES intervention in person. The agenda for the first face to face visit for caregivers (suggested timeline 5-7 days after hospice admission) includes an explanation of the purpose of the visit/call. During the first session, the interventionist works on steps one and two of the ADAPT model, namely Attitude and Defining the Problem and Setting Realistic Goals. During the second visit (suggested timeline 11-13 days after hospice admission) the interventionist covers steps three and four of the ADAPT model. Step three encourages caregivers in being creative and generating alternative solutions. Step four focuses on predicting the consequences and developing a solution plan. The third visit (suggested timeline 16-18 days after hospice admission) focuses on step five, namely trying out the solution plan and determining if it works. PISCES: The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients.
154
Group 2 (PISCES Video)
In this group, participants will receive the PISCES intervention in three sessions; however, the first session will be delivered face to face and the other two via video or phone. The three intervention sessions will be scheduled with a suggested timeline between days 5 and 18 of the hospice admission. The first session will take place in person (suggested timeline 5-7 days after hospice admission). After the first session where the in-person encounter will allow for the establishment of rapport between the interventionist and the caregiver, the second session (suggested timeline 11-13 days after hospice admission) and the third session (suggested timeline 16-18 days after hospice admissions) will be conducted via live videoconferencing. If the caregiver already has access to a computer and Internet, they will utilize the videoconferencing solution. If videoconferencing is not feasible, the sessions will be delivered over the regular phone. PISCES: The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients.
152
Group 3 (PISCESplus)
PISCESplus is meant to be an enhanced version of the PISCES intervention including the original problem solving therapy modules with the addition of positive reappraisal elements. The suggested timeline for the first session which will be in person is 5-7 days after hospice admission. At the end of the first session, the interventionist will ask the caregiver to take the time to think about and identify some positive aspects of caregiving. At the end of the second session (which is scheduled to take place via video approx. 11-13 days after admission) the interventionist will ask the caregiver to go over the benefits or positive aspects of caregiving that they had identified and ask them to comment as to why they perceive these as positive or beneficial. The third session will also take place via video. PISCES: The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients.
154
Group 4 PISCESplus Online
In this group, participants receive the entire intervention (PISCES plus-so the PISCES intervention with the positive reappraisal enhancements) online and complete all surveys electronically. All pre-and post assessments are conducted online and the PISCES sessions are carried out online as well.
63
Total523

Baseline characteristics

CharacteristicGroup 1 (PISCES-f2f)Group 2 (PISCES Video)Group 3 (PISCESplus)Group 4 PISCESplus OnlineTotal
Age, Continuous56.8 years
STANDARD_DEVIATION 12.7
58.8 years
STANDARD_DEVIATION 12.8
57.4 years
STANDARD_DEVIATION 12.2
56.1 years
STANDARD_DEVIATION 17.2
57.4 years
STANDARD_DEVIATION 13.2
Caregiver Added Expense
Decline to Answer
1 Participants1 Participants1 Participants0 Participants3 Participants
Caregiver Added Expense
No
32 Participants36 Participants33 Participants19 Participants120 Participants
Caregiver Added Expense
Unknown or Not Reported
9 Participants11 Participants20 Participants1 Participants41 Participants
Caregiver Added Expense
Yes
112 Participants104 Participants100 Participants43 Participants359 Participants
Caregiver Dementia
Don't Know
35 Participants35 Participants35 Participants5 Participants110 Participants
Caregiver Dementia
No
14 Participants8 Participants9 Participants1 Participants32 Participants
Caregiver Dementia
Unknown or Not Reported
99 Participants105 Participants105 Participants36 Participants345 Participants
Caregiver Dementia
Yes
6 Participants4 Participants5 Participants21 Participants36 Participants
Caregiver Diagnosis
Cancer
11 Participants6 Participants10 Participants5 Participants32 Participants
Caregiver Diagnosis
Dementia
2 Participants3 Participants2 Participants13 Participants20 Participants
Caregiver Diagnosis
Other
38 Participants35 Participants33 Participants5 Participants111 Participants
Caregiver Diagnosis
Unknown or Not Reported
103 Participants108 Participants109 Participants40 Participants360 Participants
Caregiver Distance from Receiver
Decline to Answer
2 Participants0 Participants1 Participants0 Participants3 Participants
Caregiver Distance from Receiver
Less than 1 hour away
49 Participants61 Participants42 Participants19 Participants171 Participants
Caregiver Distance from Receiver
More than 1 hour away
4 Participants8 Participants10 Participants6 Participants28 Participants
Caregiver Distance from Receiver
Unknown or Not Reported
9 Participants11 Participants20 Participants1 Participants41 Participants
Caregiver Distance from Receiver
With you
90 Participants72 Participants81 Participants37 Participants280 Participants
Caregiver Education
Bachelor's Degree
40 Participants27 Participants37 Participants17 Participants121 Participants
Caregiver Education
Graduate/Professional Degree
41 Participants45 Participants28 Participants22 Participants136 Participants
Caregiver Education
High School/GED
24 Participants27 Participants25 Participants6 Participants82 Participants
Caregiver Education
Less than High School
2 Participants1 Participants2 Participants0 Participants5 Participants
Caregiver Education
Some College/Associate Degree
38 Participants42 Participants43 Participants17 Participants140 Participants
Caregiver Education
Unknown or Not Reported
9 Participants10 Participants19 Participants1 Participants39 Participants
Caregiver Generalized Anxiety Disorder (GAD-7) Score6.69 units on a scale
STANDARD_DEVIATION 5.4
5.74 units on a scale
STANDARD_DEVIATION 4.9
6.32 units on a scale
STANDARD_DEVIATION 4.9
5.85 units on a scale
STANDARD_DEVIATION 5.2
6.2 units on a scale
STANDARD_DEVIATION 5.1
Caregiver Marital Status
Decline to Answer
0 Participants1 Participants0 Participants0 Participants1 Participants
Caregiver Marital Status
Married/Partnered
67 Participants69 Participants76 Participants33 Participants245 Participants
Caregiver Marital Status
Separated/Divorced
18 Participants18 Participants14 Participants7 Participants57 Participants
Caregiver Marital Status
Single/Never Married/Partnered
37 Participants38 Participants25 Participants20 Participants120 Participants
Caregiver Marital Status
Unknown or Not Reported
9 Participants10 Participants19 Participants1 Participants39 Participants
Caregiver Marital Status
Widowed
23 Participants16 Participants20 Participants2 Participants61 Participants
Caregiver PHQ-9 Score7.54 units on a scale
STANDARD_DEVIATION 5.7
6.6 units on a scale
STANDARD_DEVIATION 5.4
6.99 units on a scale
STANDARD_DEVIATION 5.3
6.78 units on a scale
STANDARD_DEVIATION 5.36
7.0 units on a scale
STANDARD_DEVIATION 5.5
Caregiver Quality of Life Index (CQLI-R)27.7 units on a scale
STANDARD_DEVIATION 8
28.5 units on a scale
STANDARD_DEVIATION 8.4
29.32 units on a scale
STANDARD_DEVIATION 7.2
28.31 units on a scale
STANDARD_DEVIATION 7.7
28.5 units on a scale
STANDARD_DEVIATION 7.9
Caregiver Relation
Adult Child
70 Participants69 Participants74 Participants38 Participants251 Participants
Caregiver Relation
Decline to Answer
1 Participants0 Participants0 Participants0 Participants1 Participants
Caregiver Relation
Other
20 Participants20 Participants12 Participants7 Participants59 Participants
Caregiver Relation
Parent
7 Participants7 Participants5 Participants1 Participants20 Participants
Caregiver Relation
Sibling
6 Participants4 Participants3 Participants1 Participants14 Participants
Caregiver Relation
Spouse/Partner
41 Participants42 Participants41 Participants15 Participants139 Participants
Caregiver Relation
Unknown or Not Reported
9 Participants10 Participants19 Participants1 Participants39 Participants
Caregiver Status
Active
107 Participants102 Participants103 Participants59 Participants371 Participants
Caregiver Status
Bereaved
43 Participants47 Participants46 Participants4 Participants140 Participants
Caregiver Status
Unknown or Not Reported
4 Participants3 Participants5 Participants0 Participants12 Participants
Caregiver Time Caring
1-3 years
32 Participants31 Participants28 Participants26 Participants117 Participants
Caregiver Time Caring
3 years or more
69 Participants62 Participants65 Participants22 Participants218 Participants
Caregiver Time Caring
Decline to Answer
2 Participants2 Participants1 Participants1 Participants6 Participants
Caregiver Time Caring
Less than 1 year
42 Participants46 Participants40 Participants13 Participants141 Participants
Caregiver Time Caring
Unknown or Not Reported
9 Participants11 Participants20 Participants1 Participants41 Participants
Caregiver Time Spent Caring per week
11-20 hours
22 Participants13 Participants20 Participants9 Participants64 Participants
Caregiver Time Spent Caring per week
5-10 hours
16 Participants20 Participants12 Participants11 Participants59 Participants
Caregiver Time Spent Caring per week
Decline to Answer
1 Participants2 Participants2 Participants1 Participants6 Participants
Caregiver Time Spent Caring per week
Less than 5 hours
6 Participants10 Participants7 Participants4 Participants27 Participants
Caregiver Time Spent Caring per week
More than 20 hours
100 Participants96 Participants93 Participants37 Participants326 Participants
Caregiver Time Spent Caring per week
Unknown or Not Reported
9 Participants11 Participants20 Participants1 Participants41 Participants
Caregiver Work Status
Decline to Answer
1 Participants0 Participants0 Participants0 Participants1 Participants
Caregiver Work Status
No
83 Participants75 Participants73 Participants35 Participants266 Participants
Caregiver Work Status
Unknown or Not Reported
9 Participants11 Participants20 Participants1 Participants41 Participants
Caregiver Work Status
Yes
61 Participants66 Participants61 Participants27 Participants215 Participants
Caregiver Work Support
Cut back on hours or quit work entirely
18 Participants15 Participants16 Participants4 Participants53 Participants
Caregiver Work Support
Decline to Answer
4 Participants8 Participants5 Participants0 Participants17 Participants
Caregiver Work Support
Left one job for a different one
1 Participants3 Participants1 Participants2 Participants7 Participants
Caregiver Work Support
None of these apply
8 Participants4 Participants6 Participants9 Participants27 Participants
Caregiver Work Support
Selected More than 1 option
25 Participants29 Participants29 Participants8 Participants91 Participants
Caregiver Work Support
Taken a job or worked additional hours to earn more money
1 Participants0 Participants2 Participants2 Participants5 Participants
Caregiver Work Support
Taken an unpaid leave or any leave under Family Medical Leave Act
5 Participants4 Participants6 Participants1 Participants16 Participants
Caregiver Work Support
Unknown or Not Reported
72 Participants76 Participants74 Participants28 Participants250 Participants
Caregiver Work Support
Used your own sick leave or vacation time
20 Participants13 Participants15 Participants9 Participants57 Participants
Care Receiver Ethnicity
Decline to Answer
2 Participants1 Participants2 Participants2 Participants7 Participants
Care Receiver Ethnicity
Hispanic
6 Participants8 Participants11 Participants5 Participants30 Participants
Care Receiver Ethnicity
Non-Hispanic
136 Participants133 Participants120 Participants55 Participants444 Participants
Care Receiver Ethnicity
Unknown or Not Reported
10 Participants10 Participants21 Participants1 Participants42 Participants
Care Receiver Gender
Female
75 Participants83 Participants64 Participants47 Participants269 Participants
Care Receiver Gender
Male
69 Participants59 Participants69 Participants15 Participants212 Participants
Care Receiver Gender
Unknown or Not Reported
10 Participants10 Participants21 Participants1 Participants42 Participants
Care Receiver Marital Status
Married/Partnered
57 Participants59 Participants58 Participants24 Participants198 Participants
Care Receiver Marital Status
Separated/Divorced
21 Participants20 Participants15 Participants9 Participants65 Participants
Care Receiver Marital Status
Single/Never Married/Partnered
19 Participants18 Participants12 Participants10 Participants59 Participants
Care Receiver Marital Status
Unknown or Not Reported
10 Participants10 Participants20 Participants1 Participants41 Participants
Care Receiver Marital Status
Widowed
47 Participants45 Participants49 Participants19 Participants160 Participants
Care Receiver Race
American Indian or Alaska Native
0 Participants0 Participants1 Participants0 Participants1 Participants
Care Receiver Race
Asian
5 Participants2 Participants3 Participants3 Participants13 Participants
Care Receiver Race
Black or African American
63 Participants55 Participants50 Participants25 Participants193 Participants
Care Receiver Race
More than one race
9 Participants8 Participants10 Participants2 Participants29 Participants
Care Receiver Race
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Care Receiver Race
Unknown or Not Reported
2 Participants3 Participants3 Participants0 Participants8 Participants
Care Receiver Race
White
75 Participants84 Participants87 Participants33 Participants279 Participants
Care Receiver Residence
Assisted Living Facility/Nursing Home/Skilled Nursing Facility
18 Participants22 Participants13 Participants2 Participants55 Participants
Care Receiver Residence
Other
4 Participants5 Participants4 Participants6 Participants19 Participants
Care Receiver Residence
Private Home Residence/Adult Group Home
123 Participants115 Participants117 Participants54 Participants409 Participants
Care Receiver Residence
Unknown or Not Reported
9 Participants10 Participants20 Participants1 Participants40 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants8 Participants11 Participants9 Participants35 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
138 Participants136 Participants134 Participants51 Participants459 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
9 Participants8 Participants9 Participants3 Participants29 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants1 Participants1 Participants2 Participants
Race (NIH/OMB)
Asian
3 Participants1 Participants3 Participants2 Participants9 Participants
Race (NIH/OMB)
Black or African American
64 Participants56 Participants53 Participants23 Participants196 Participants
Race (NIH/OMB)
More than one race
12 Participants8 Participants14 Participants8 Participants42 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants5 Participants4 Participants1 Participants13 Participants
Race (NIH/OMB)
White
72 Participants82 Participants79 Participants28 Participants261 Participants
Sex/Gender, Customized
Female
129 Participants113 Participants130 Participants51 Participants423 Participants
Sex/Gender, Customized
Male
23 Participants34 Participants20 Participants12 Participants89 Participants
Sex/Gender, Customized
Unknown or Decline to Answer
2 Participants5 Participants4 Participants0 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 1540 / 1520 / 1540 / 63
other
Total, other adverse events
0 / 1540 / 1520 / 1540 / 63
serious
Total, serious adverse events
0 / 1540 / 1520 / 1540 / 63

Outcome results

Primary

Table 2. Comparison of 4 Groups

Comparison of 4 groups Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more anxiety) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome (more distress) Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome (better quality of life)

Time frame: from baseline to follow-up (prior to intervention-day 1 to post intervention-approx. day 30)

ArmMeasureGroupValue (MEAN)Dispersion
Group 1 (PISCES Face to Face)Table 2. Comparison of 4 GroupsDifference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)1.14 units on a scaleStandard Deviation 6.42
Group 1 (PISCES Face to Face)Table 2. Comparison of 4 GroupsDifference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)-2.54 units on a scaleStandard Deviation 4.25
Group 1 (PISCES Face to Face)Table 2. Comparison of 4 GroupsDifference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)-2.69 units on a scaleStandard Deviation 4.29
Group 2 (PISCES Delivered in a Hybrid Format)Table 2. Comparison of 4 GroupsDifference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)0.77 units on a scaleStandard Deviation 4.82
Group 2 (PISCES Delivered in a Hybrid Format)Table 2. Comparison of 4 GroupsDifference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)-1.56 units on a scaleStandard Deviation 4.19
Group 2 (PISCES Delivered in a Hybrid Format)Table 2. Comparison of 4 GroupsDifference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)-1.49 units on a scaleStandard Deviation 4.06
Group 3 (PISCESplus)Table 2. Comparison of 4 GroupsDifference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)-2.27 units on a scaleStandard Deviation 4.56
Group 3 (PISCESplus)Table 2. Comparison of 4 GroupsDifference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)-1.87 units on a scaleStandard Deviation 4.59
Group 3 (PISCESplus)Table 2. Comparison of 4 GroupsDifference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)0.27 units on a scaleStandard Deviation 7.17
Group 4 (PISCESplus Online)Table 2. Comparison of 4 GroupsDifference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)-1.52 units on a scaleStandard Deviation 5.12
Group 4 (PISCESplus Online)Table 2. Comparison of 4 GroupsDifference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)1.15 units on a scaleStandard Deviation 5.8
Group 4 (PISCESplus Online)Table 2. Comparison of 4 GroupsDifference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)-2.02 units on a scaleStandard Deviation 4.14
p-value: 0.186Kruskal-Wallis
p-value: 0.2752Kruskal-Wallis
p-value: 0.6233Kruskal-Wallis
Primary

Table 3. Comparison of Traditional PISCES vs. Online PISCES

Comparison of Traditional PISCES vs. Online PISCES Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more problems) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome

Time frame: from baseline to follow-up (time point 1 is pre-intervention, i.e., day 0 and time point 2 is post-intervention, approx. day 30)

ArmMeasureGroupValue (MEAN)Dispersion
Group 1 (PISCES Face to Face)Table 3. Comparison of Traditional PISCES vs. Online PISCESDifference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)-2.04 units on a scaleStandard Deviation 4.18
Group 1 (PISCES Face to Face)Table 3. Comparison of Traditional PISCES vs. Online PISCESDifference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)-2.15 units on a scaleStandard Deviation 4.27
Group 1 (PISCES Face to Face)Table 3. Comparison of Traditional PISCES vs. Online PISCESDifference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)0.96 units on a scaleStandard Deviation 5.7
Group 2 (PISCES Delivered in a Hybrid Format)Table 3. Comparison of Traditional PISCES vs. Online PISCESDifference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)-2.03 units on a scaleStandard Deviation 4.74
Group 2 (PISCES Delivered in a Hybrid Format)Table 3. Comparison of Traditional PISCES vs. Online PISCESDifference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)-1.91 units on a scaleStandard Deviation 4.44
Group 2 (PISCES Delivered in a Hybrid Format)Table 3. Comparison of Traditional PISCES vs. Online PISCESDifference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)0.54 units on a scaleStandard Deviation 6.76
p-value: 0.5638Wilcoxon (Mann-Whitney)
p-value: 0.9848Wilcoxon (Mann-Whitney)
p-value: 0.9169Wilcoxon (Mann-Whitney)
Primary

Table 4. Within-Group Comparison Baseline vs. Follow-up

Within-Group Comparison Baseline vs. Follow-up Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more problems) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome

Time frame: from baseline to follow-up (time point 1 is pre-intervention-day 0 and time point 2 is post-intervention-approx. day 30)

ArmMeasureGroupValue (MEAN)Dispersion
Group 1 (PISCES Face to Face)Table 4. Within-Group Comparison Baseline vs. Follow-upGeneralised Anxiety Disorder Assessment (GAD-7)-2.04 units on a scaleStandard Deviation 4.18
Group 1 (PISCES Face to Face)Table 4. Within-Group Comparison Baseline vs. Follow-upPatient Health Questionnaire 9 (PHQ9)-2.15 units on a scaleStandard Deviation 4.27
Group 1 (PISCES Face to Face)Table 4. Within-Group Comparison Baseline vs. Follow-upCaregiver Quality of Life Index (CQLI-R)0.96 units on a scaleStandard Deviation 5.7
Group 2 (PISCES Delivered in a Hybrid Format)Table 4. Within-Group Comparison Baseline vs. Follow-upGeneralised Anxiety Disorder Assessment (GAD-7)-2.03 units on a scaleStandard Deviation 4.74
Group 2 (PISCES Delivered in a Hybrid Format)Table 4. Within-Group Comparison Baseline vs. Follow-upPatient Health Questionnaire 9 (PHQ9)-1.91 units on a scaleStandard Deviation 4.44
Group 2 (PISCES Delivered in a Hybrid Format)Table 4. Within-Group Comparison Baseline vs. Follow-upCaregiver Quality of Life Index (CQLI-R)0.54 units on a scaleStandard Deviation 6.76
p-value: <0.0001Wilcoxon Signed Rank Test
p-value: <0.0001Wilcoxon Signed Rank Test
p-value: 0.0155Wilcoxon Signed Rank Test
p-value: <0.0001Wilcoxon Signed Rank Test
p-value: <0.0001Wilcoxon Signed Rank Test
p-value: 0.0504Wilcoxon Signed Rank Test

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026