Impact of an Online Positive Affect Journaling Intervention

NCT ID: NCT01873599

Last Updated: 2014-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-02-28

Brief Summary

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In this study the investigators plan to recruit 70 patients reporting high levels of stress to test the impact of Positive Affect Journaling. Patients randomized to use the online intervention will be asked to journal about one of seven topics, several days each week, for three months. The topics (e.g., "What went well") are designed to help the individual focus on some positive aspect of their life or themselves over the past day. Each topic is based on prompts shown to be effective in studies of up to one week in duration. In the summer of 2012, our research team pilot tested each prompt with 20 patients with high levels of anxiety, which led to important changes to the prompts, to increase their potential impact. The main aim is to understand the impact of Positive Affect Journaling on psychological distress, as measured by the National Health Interview Survey.

Detailed Description

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Conditions

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Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Participants in the intervention condition will be asked to write for 15 minutes on three days each week to one of the seven positive affect writing prompts on www.stressvax.com. Subjects who do not complete a journal entry within 7 days will receive an email reminder, in case they have lost their password or have some technical problem accessing the site.

Group Type EXPERIMENTAL

Positive Affect Journaling

Intervention Type BEHAVIORAL

Control

As there is no clinical standard of care treatment for psychological distress, patients randomized into this condition will receive their usual care. At the end of three months, subjects in this condition will be given access to the positive affect journaling intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Positive Affect Journaling

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Fluently speaks, writes, and read English
* Report elevated levels of stress
* Be between 21-80 years of age
* Have access to the Internet
* Have an ECOG Performance Status of 0 (Fully active) through 3 (Limited self-care)

Exclusion Criteria

* High risk for suicidality on the Structured Clinical Interview for DSM Disorders (SCID).
* Pregnant or planning to get pregnant in the next 3 months
* Moving in the next 6 months
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Penn State University

OTHER

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Christopher Sciamanna, MD, MPH

Chief, Division of General Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Sciamanna

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

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Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

References

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Smyth JM, Johnson JA, Auer BJ, Lehman E, Talamo G, Sciamanna CN. Online Positive Affect Journaling in the Improvement of Mental Distress and Well-Being in General Medical Patients With Elevated Anxiety Symptoms: A Preliminary Randomized Controlled Trial. JMIR Ment Health. 2018 Dec 10;5(4):e11290. doi: 10.2196/11290.

Reference Type DERIVED
PMID: 30530460 (View on PubMed)

Other Identifiers

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41160EP

Identifier Type: -

Identifier Source: org_study_id

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