Narrative Intervention for Chronic Illness

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Heart Failure, Heart Failure NYHA Class III, Heart Failure NYHA Class IV

Intervention / Treatment
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* Behavioral: Narrative Intervention for Chronic Illness-Heart Failure
* Other: Attention Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study will have two arms, intervention and attention control arms.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NICI-HF<br>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<br>* 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.<br>|
| Placebo Comparator: Attention control<br>This arm will receive regular emails with information about heart failure for 3 months. | Other: Attention Control<br>* Automated emails at similar time points to the intervention will be sent to participants in this arm. Emails will ask participants to reflect on their illness experience and offer general information about heart failure using standardized handouts from the American Heart Association and Up-To-Date.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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