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Behavioral Intervention

PISCES for Generalized Anxiety Disorder

N/A
Waitlist Available
Research Sponsored by George Demiris, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to follow-up (time point 1 is pre-intervention-day 0 and time point 2 is post-intervention-approx. day 30)
Awards & highlights

Study Summary

This trial will compare the effectiveness of two different versions of an intervention designed to support caregivers of hospice patients, one delivered in person and one delivered online.

Eligible Conditions
  • Generalized Anxiety Disorder
  • Quality of Life
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to follow-up (time point 1 is pre-intervention-day 0 and time point 2 is post-intervention-approx. day 30)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to follow-up (time point 1 is pre-intervention-day 0 and time point 2 is post-intervention-approx. day 30) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Table 2. Comparison of 4 Groups
Table 3. Comparison of Traditional PISCES vs. Online PISCES
Table 4. Within-Group Comparison Baseline vs. Follow-up

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Group 4 (PISCESplus online)Experimental Treatment1 Intervention
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.
Group II: Group 3 (PISCESplus)Experimental Treatment1 Intervention
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.
Group III: Group 2 (PISCES delivered in a hybrid format)Experimental Treatment1 Intervention
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.
Group IV: Group 1 (PISCES face to face)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PISCES
2018
N/A
~530

Find a Location

Who is running the clinical trial?

National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,038 Total Patients Enrolled
George Demiris, PhDLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies in this medical experiment for participants?

"This particular medical trial, which was originally published on October 23rd 2018 and most recently updated in August 1st 2022 is not currently seeking study participants. Nevertheless, there are many other clinical trials that have open recruitment at the moment, with a total of 1364 studies recruiting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Problem Solving Intervention for Hospice Caregivers
George Demiris, PhD 2018. "A Problem Solving Intervention for Hospice Caregivers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03712410.
~80 spots leftby Apr 2025
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