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Expressive Writing Intervention for Emotional Distress in Caregivers

N/A

Recruiting

Research Sponsored by Arizona State University

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 change from baseline depression at 6 weeks

Awards & highlights

Study Summary

This trial will test if expressive writing can improve mood & quality of life for caregivers of persons with cancer in group-based sessions guided by trained facilitators.

Who is the study for?

This trial is for adults over 18 who speak English and are informal caregivers to an adult with stage II-IV breast, ovarian, prostate, colon, rectal, or lung cancer diagnosed in the last 2 years. They must have WIFI and a device for video calls and surveys. It's not for those caring for children with cancer.Check my eligibility

What is being tested?

The study tests if group-based expressive writing via videoconference can improve mood and quality of life in caregivers of cancer patients. Participants write about their feelings on caregiving then discuss it in groups led by a trained facilitator. Some will start immediately; others will wait to see which method works better.See study design

What are the potential side effects?

While there aren't typical medical side effects as this isn't a drug trial, participants may experience emotional distress or discomfort when sharing deep personal thoughts during the expressive writing sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline psychological distress at 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline psychological distress at 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline psychological distress at 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Psychological distress

Quality of life, caregiver-specific

Quality of life, general

Secondary outcome measures

Depression

Perceived stress

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active interventionExperimental Treatment1 Intervention

Participants will attend four group-based expressive writing sessions led by a trained facilitator. All sessions will be delivered via videoconference. Sessions will occur weekly over the course of 4 consecutive weeks and will not exceed 60 minutes in length. Each session will include a 15- to 20-minute writing stint whereby participants are asked to write about their deepest thoughts and feelings regarding their loved one's cancer and their role as caregiver. All participants will be given a Rocketbook for this purpose, a spiral notebook that has the look and feel of a standard paper notebook but uses a pen with erasable ink. The writing stint will be followed by a group discussion; participants will be invited to share what they wrote about (if so desired) and their reactions to the writing process. Each session will end with a debriefing and erasure of the writing content just created. This will ensure privacy of the material and may be perceived as cleansing.

Group II: Waitlist controlPlacebo Group1 Intervention

Procedures are exactly the same as for the experimental arm but delayed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Expressive writing intervention

2021

N/A

~700

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cancer Support Community ArizonaUNKNOWN

Arizona State UniversityLead Sponsor

283 Previous Clinical Trials

109,414 Total Patients Enrolled

Media Library

Expressive writing intervention Clinical Trial Eligibility Overview. Trial Name: NCT05859880 — N/A

Quality of Life Research Study Groups: Active intervention, Waitlist control

Quality of Life Clinical Trial 2023: Expressive writing intervention Highlights & Side Effects. Trial Name: NCT05859880 — N/A

Expressive writing intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05859880 — N/A

Frequently Asked Questions

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

Are there any remaining opportunities for people to participate in this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that, as of June 30th 2023, this trial is actively seeking participants; the initial posting was on 8th June 2023. A total of 100 patients will be recruited from a single location."

Answered by AI

What is the scope of participants in this experiment?

"Affirmative. Clinicaltrials.gov has verified that this trial, which was initially posted on June 8th 2023 is currently recruiting participants. A total of 100 individuals must be enrolled at a single medical facility."

Answered by AI

Recent research and studies

Social Psychiatry and Psychiatric EpidemiologyJournal

Evaluating the Seven-item Center for Epidemiologic Studies Depression Scale Short-form: A Longitudinal US Community Study

Levine, Stephen Z.. 2013. “Evaluating the Seven-item Center for Epidemiologic Studies Depression Scale Short-form: A Longitudinal US Community Study”. Social Psychiatry and Psychiatric Epidemiology. Springer Science and Business Media LLC. doi:10.1007/s00127-012-0650-2.

clinicaltrials.govStudy

Expressive Writing for Caregivers of Persons With Cancer

2023. "Expressive Writing for Caregivers of Persons With Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05859880.