Anxiety GeneralizedNCT03712410

A Problem Solving Intervention for Hospice Caregivers

A study testing PISCES in people with Anxiety Generalized and Quality of Life, run by George Demiris, PhD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Anxiety Generalized, Quality of Life, Depression
What is being tested?: PISCES
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 523 participants
Where: 1 siteUnited States
Study dates: 23 Oct 2018to 30 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Conditions: Anxiety Generalized, Quality of Life, Depression
Being tested: PISCES
Medical subject headings: Generalized Anxiety Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03712410
Study group	Role	What they receive
Group 1 (PISCES face to face)	Active comparator	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. Receives: Behavioral: PISCES
Group 2 (PISCES delivered in a hybrid format)	Experimental	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. 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. Receives: Behavioral: PISCES
Group 3 (PISCESplus)	Experimental	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. Receives: Behavioral: PISCES
Group 4 (PISCESplus online)	Experimental	Participants in this group receive the PISCES plus intervention (the PISCES intervention with the enhancement of the positive reappraisal elements) delivered fully online. All assessments and sessions take place online. Receives: Behavioral: PISCES

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 201830 Dec 2022

First posted19 Oct 2018
Study start23 Oct 2018
Primary completion15 Dec 2022
Study completion30 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Anxiety GeneralizedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 523 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03712410
Sponsor's protocol ID: 828990
Other IDs: R01NR012213
Status last verified: Jan 2023
First submitted: 15 Oct 2018
Last updated: 16 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Oh O, Oliver DP, Washington K, Demiris G. When Is the Best Time to Deliver Supportive Interventions to Hospice Family Caregivers? A Multi-Method Study. Gerontologist. 2025 Apr 9;65(5):gnaf085. doi: 10.1093/geront/gnaf085.
PubMed 39985289

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Problem Solving Intervention for Hospice Caregivers
ClinicalTrials.gov ID: NCT03712410
Acronym / sponsor ID: 828990
Conditions: Anxiety Generalized, Quality of Life, Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 523 participants (actual)
Lead sponsor: George Demiris, PhDUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: 23 Oct 2018 (actual)
Primary completion: 15 Dec 2022 (actual)
Study completion: 30 Dec 2022 (actual)
First posted: 19 Oct 2018 (actual)
Results: Posted 25 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1 (PISCES face to face)	Active comparator	Behavioral: PISCESFamily 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.
Group 2 (PISCES delivered in a hybrid format)	Experimental	Behavioral: PISCESIn 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. 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.
Group 3 (PISCESplus)	Experimental	Behavioral: PISCESPISCESplus 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.
Group 4 (PISCESplus online)	Experimental	Behavioral: PISCESParticipants in this group receive the PISCES plus intervention (the PISCES intervention with the enhancement of the positive reappraisal elements) delivered fully online. All assessments and sessions take place online.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PISCESThe intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients.	Behavioural	Group 1 (PISCES face to face), Group 2 (PISCES delivered in a hybrid format), Group 3 (PISCESplus), Group 4 (PISCESplus online)

Primary outcome

Table 2. Comparison of 4 Groups
Time frame: from 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 PISCES
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)
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-up
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)
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

Results and safety

Results posted to the registry on 25 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 (PISCES-f2f)	154	115
Group 2 (PISCES Video)	152	106
Group 3 (PISCESplus)	154	101
Group 4 PISCESplus Online	63	46

Primary outcome: Table 2. Comparison of 4 Groups

Time frame: from baseline to follow-up (prior to intervention-day 1 to post intervention-approx. day 30). Mean (Standard Deviation). Unit: units on a scale

Measure	Group 1 (PISCES Face to Face) n = 154	Group 2 (PISCES Delivered in a Hybrid Format) n = 152	Group 3 (PISCESplus) n = 154	Group 4 (PISCESplus Online) n = 63
Difference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)	-2.54 (4.25)	-1.49 (4.06)	-2.27 (4.56)	-1.52 (5.12)
Difference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)	-2.69 (4.29)	-1.56 (4.19)	-1.87 (4.59)	-2.02 (4.14)
Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)	1.14 (6.42)	0.77 (4.82)	0.27 (7.17)	1.15 (5.80)

Group 1 (PISCES Face to Face) vs Group 2 (PISCES Delivered in a Hybrid Format) vs Group 3 (PISCESplus) vs Group 4 (PISCESplus Online): p = 0.1860, Kruskal-Wallis
Group 1 (PISCES Face to Face) vs Group 2 (PISCES Delivered in a Hybrid Format) vs Group 3 (PISCESplus) vs Group 4 (PISCESplus Online): p = 0.2752, Kruskal-Wallis
Group 1 (PISCES Face to Face) vs Group 2 (PISCES Delivered in a Hybrid Format) vs Group 3 (PISCESplus) vs Group 4 (PISCESplus Online): p = 0.6233, Kruskal-Wallis

Primary outcome: Table 3. Comparison of Traditional PISCES vs. Online PISCES

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). Mean (Standard Deviation). Unit: units on a scale

Measure	Traditional PISCES n = 306	Online PISCES n = 217
Difference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)	-2.04 (4.18)	-2.03 (4.74)
Difference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)	-2.15 (4.27)	-1.91 (4.44)
Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)	0.96 (5.70)	0.54 (6.76)

Traditional PISCES vs Online PISCES: p = 0.5638, Wilcoxon (Mann-Whitney)
Traditional PISCES vs Online PISCES: p = 0.9848, Wilcoxon (Mann-Whitney)
Traditional PISCES vs Online PISCES: p = 0.9169, Wilcoxon (Mann-Whitney)

Primary outcome: Table 4. Within-Group Comparison Baseline vs. Follow-up

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). Mean (Standard Deviation). Unit: units on a scale

Measure	Traditional PISCES n = 306	Online PISCES n = 217
Generalised Anxiety Disorder Assessment (GAD-7)	-2.04 (4.18)	-2.03 (4.74)
Patient Health Questionnaire 9 (PHQ9)	-2.15 (4.27)	-1.91 (4.44)
Caregiver Quality of Life Index (CQLI-R)	0.96 (5.70)	0.54 (6.76)

Traditional PISCES: p <0.0001, Wilcoxon Signed Rank Test
Traditional PISCES: p <0.0001, Wilcoxon Signed Rank Test
Traditional PISCES: p = 0.0155, Wilcoxon Signed Rank Test

Adverse events

Time frame: Adverse event data were collected over the duration of an individual participant's time in the study (which ranged from 4 to 6 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 (PISCES-f2f)	0 of 154 (0%)	0 of 154 (0%)	0 of 154
Group 2 (PISCES Video)	0 of 152 (0%)	0 of 152 (0%)	0 of 152
Group 3 (PISCESplus)	0 of 154 (0%)	0 of 154 (0%)	0 of 154
Group 4 PISCESplus Online	0 of 63 (0%)	0 of 63 (0%)	0 of 63

Limitations and caveats (from the sponsor): Because of the COVID pandemic we implemented some changes in the study protocol for each group and converted data collection to online questionnaires.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39985289Oh O, Oliver DP, Washington K, Demiris G. When Is the Best Time to Deliver Supportive Interventions to Hospice Family Caregivers? A Multi-Method Study. Gerontologist. 2025 Apr 9;65(5):gnaf085. doi: 10.1093/geront/gnaf085.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

George Demiris, PhD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PISCES in people with Anxiety Generalized and Quality of Life, run by George Demiris, PhD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Table 2. Comparison of 4 Groups (time frame: from baseline to follow-up (prior to intervention-day 1 to post intervention-approx. day 30)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03712410, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.