NICI: Narrative Intervention for Chronic Illness

Sponsor

University of Colorado, Denver (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06097481

Collaborator

(none)

300

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The proposed study will test the NICI intervention. This study will gain insight into living with heart failure and learn if the NICI intervention is feasible and acceptable for people living with heart failure in both rural and urban locations. The study has two specific aims:

Explore patterns and themes in illness narratives shared using thematic narrative inquiry to inform the tailoring content of the intervention (Phase 1).
Establish the acceptability, satisfaction, and feasibility of an asynchronous narrative intervention for people living with HF in both rural and urban settings. Review trends and patterns in depression and anxiety outcomes in both rural and urban settings for efficacy. (Phase 2).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Heart Failure NYHA Class III Heart Failure NYHA Class IV	Behavioral: Narrative Intervention for Chronic Illness-Heart Failure	Phase 1/Phase 2

Detailed Description

This study will enroll people living with NYHA class III or IV heart failure. Participants will be randomized to the two arms.

In arm 1, participants write illness narratives in response to a prompt given to them by a licensed mental health therapist through email. Each participant will receive tailored feedback and additional prompts to reflect on their narrative and explore their experience using narrative therapy techniques.
In arm 2, participants will be encouraged to write about the illness experience and be offered handouts with information about heart failure. This will serve as an attention control.
Emails will be sent biweekly for 3 months for each arm.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Study will have two arms, intervention and attention control arms.Study will have two arms, intervention and attention control arms.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Participants will not know if they are in the intervention or attention control arm. Statisticians will not know arm when assessing outcomes.

Primary Purpose:

Supportive Care

Official Title:

The Narrative Intervention for Chronic Illness- Heart Failure (NICI-HF) Study

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NICI-HF This arm will receive the NICI-HF intervention with regular emails from a therapist for 3 months.	Behavioral: Narrative Intervention for Chronic Illness-Heart Failure The Narrative Intervention for Chronic Illness-Heart Failure includes narrative-based, strengths-based, solution-focused brief therapy, and Unitary Caring Science to improve depression (primary outcome) and anxiety (secondary outcome) for people living with heart failure.
Placebo Comparator: Attention control This arm will receive regular emails with information about heart failure for 3 months.	Behavioral: Narrative Intervention for Chronic Illness-Heart Failure The Narrative Intervention for Chronic Illness-Heart Failure includes narrative-based, strengths-based, solution-focused brief therapy, and Unitary Caring Science to improve depression (primary outcome) and anxiety (secondary outcome) for people living with heart failure.

Arm

Intervention/Treatment

Experimental: NICI-HF

This arm will receive the NICI-HF intervention with regular emails from a therapist for 3 months.

Behavioral: Narrative Intervention for Chronic Illness-Heart Failure

The Narrative Intervention for Chronic Illness-Heart Failure includes narrative-based, strengths-based, solution-focused brief therapy, and Unitary Caring Science to improve depression (primary outcome) and anxiety (secondary outcome) for people living with heart failure.

Placebo Comparator: Attention control

This arm will receive regular emails with information about heart failure for 3 months.

Behavioral: Narrative Intervention for Chronic Illness-Heart Failure

Outcome Measures

Primary Outcome Measures

Personal Health Questionarire-8 item (PHQ8) [Administered at baseline, 3 months, and 6 months]
The PHQ8 is a measurement of depression, found to be reliable for people living with heart failure.

Secondary Outcome Measures

Generalized Anxiety Disorder measurement- 7 item (GAD-7) [Administered at baseline, 3 months, and 6 months]
The GAD7 is a measurement of anxiety found to be reliable for people living with chronic illnesses like heart failure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Dx with Heart Failure, NYHA Class III and IV
Have an email address and able to check email regularly
Have a working phone number
Between the ages of 18-89 years old

Exclusion Criteria:

Conflicting research study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Colorado, Denver

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT06097481

Other Study ID Numbers:

23-0436

First Posted:

Oct 24, 2023

Last Update Posted:

Oct 24, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Chronic Disease

Study Results

No Results Posted as of Oct 24, 2023