SkillJoy Clinical Trial (SkillJoy)

September 1, 2021 updated by: Skidmore College

SkillJoy Randomized Controlled Trial: Testing a Smartphone Intervention for Anxiety and Reinforcement

This study is a randomized controlled trial comparing a smartphone-delivered savoring intervention (SkillJoy) for Generalized Anxiety Disorder to an active treatment control.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The current study seeks to determine if the positivity intervention SkillJoy, a smartphone-based, ecological momentary intervention (EMI), can reduce worry and generalized anxiety disorder (GAD) symptoms, increase positive emotion and wellbeing, improve reinforcement and probabilistic learning, increase savoring and reduce kill-joy thinking, and decrease avoidance of negative emotional shifts relative to an active treatment control in a GAD sample. Skills for generating positive emotion may reduce symptoms and increase well-being for those with GAD. To test this approach, participants with GAD were randomly assigned to either a savoring treatment or a self-monitoring control.The savoring treatment consisted of an ecological momentary intervention (EMI) for learning and practicing savoring skills-SkillJoy. SkillJoy prompted participants to attend to positive aspects of the present moment, plan and engage in enjoyable activities, record and reflect on positive experiences, note events that turned out well, and look forward to positive events. The active self-monitoring control EMI consisted of similar activities, but they all omitted savoring practices. These activities included attending to any current thoughts and feelings, planning everyday activities, remembering and recording daily events, and anticipating important events. Both EMIs were delivered by apps on participants' smartphones for seven days with 30th day follow-up. Secondarily, the current study will assess differences between those with GAD and non-anxious controls on a computerized probabilistic reinforcement learning task and baseline savoring questionnaires.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Saratoga Springs, New York, United States, 12866
        • Skidmore College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet clinical criteria for Generalized Anxiety Disorder on the GAD-Q-IV and the GAD section of the Mini-International Neuropsychiatric Interview (MINI).
  • Must be at least 18 years old to participate.
  • Pregnant women will be allowed to participate.

Exclusion Criteria:

  • They do not meet criteria for GAD on the GAD-Q-IV and the INI or do not fall one standard deviation below the subject pool mean on the GAD-Q-IV (i.e., they fall between these two scores).
  • They are younger than 18 years of age.
  • They do not speak English.
  • They are adults unable to consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: SkillJoy Intervention
The savoring treatment consisted of an ecological momentary intervention (EMI) for learning and practicing savoring skills-SkillJoy. SkillJoy prompted participants to attend to positive aspects of the present moment, plan and engage in enjoyable activities, record and reflect on positive experiences, note events that turned out well, and look forward to positive events.
Behavioral: SkillJoy Intervention
The savoring treatment consisted of an ecological momentary intervention (EMI) for learning and practicing savoring skills-SkillJoy. SkillJoy prompted participants to attend to positive aspects of the present moment, plan and engage in enjoyable activities, record and reflect on positive experiences, note events that turned out well, and look forward to positive events.
ACTIVE_COMPARATOR: Active Self-Monitoring Control Intervention
The active self-monitoring control EMI consisted of similar activities, but they all omitted savoring practices. These activities included attending to any current thoughts and feelings, planning everyday activities, remembering and recording daily events, and anticipating important events.
Behavioral: Active Self-Monitoring Control Intervention
The active self-monitoring control EMI prompted participants to notice and write current thoughts and feelings, plan the day's major activities, remember and write about their daily events, and anticipate upcoming important events.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Penn State Worry Questionnaire
Time Frame: 8 day post-trial; 30th day follow-up
A 16-item self-report scale of the severity and frequency of worry. Min. score of 16 and maximum score of 80. Decreases in scores suggest a better outcome.
8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Positive and Negative Affect Schedule, Expanded Form: Joviality Scale
Time Frame: 8 day post-trial; 30th day follow-up
An 8-item measure of positive emotions. Min. score of 8 and maximum score of 40. Increases in scores suggest a better outcome.
8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Savoring the Moment Subscale of the Savoring Beliefs Inventory
Time Frame: 8 day post-trial; 30th day follow-up
The SBI is a 14-item survey that measures beliefs about one's ability to savor. The savoring the moment subscale measures savoring of present-moment emotional experience. Min. score of 1 and maximum score of 7. Increases in scores suggest a better outcome.
8 day post-trial; 30th day follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in Responses to Positive Affect Scale: Dampening Subscale
Time Frame: 8 day post-trial; 30th day follow-up
Measure kill-joy thinking (a.k.a. "dampening"). Participants rated eight dampening items on a 5-point scale. Min. score of 8 and maximum score of 32. Decreases in scores suggest a better outcome.
8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Prioritizing Positivity Scale
Time Frame: 8 day post-trial; 30th day follow-up
Measures the degree to which participants prioritized seeking positive experiences on six items with which participants either agree or disagree on a nine-point scale. Min. score of 6 and maximum score of 54. Increases in scores suggest a better outcome.
8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Life Orientation Test - Revised
Time Frame: 8 day post-trial; 30th day follow-up
Measures optimism. It has 10 items rated on a four-point scale. Min. score of 6 and maximum score of 30. Increases in scores suggest a better outcome.
8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Beck Depression Inventory II
Time Frame: 8 day post-trial; 30th day follow-up
A 21-item self-report survey that measures the presence and severity of depressive symptoms. Minimum score of 0 and maximum score of 63. Decreases in scores suggest a better outcome.
8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in Contrast Avoidance Questionnaire - Worry
Time Frame: 5 day mid-trial; 8 day post-trial; 30th day follow-up
Measures frequency, severity, and motivation to use worry to cope with negative shifts in emotion and benefit from positive shifts in emotion. Min. score of 30 and maximum score of 150. Decreases in scores suggest a better outcome.
5 day mid-trial; 8 day post-trial; 30th day follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Skidmore College

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Penn State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2108-974

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Any relevant de-identified IPD will be shared to other researchers upon reasonable, direct request.

IPD Sharing Time Frame

Data will be available at the time of reasonable request.

IPD Sharing Access Criteria

Data will be provided to 1) trained and credentialed researchers who 2) make a direct request to the authors with 3) a clearly-stated rationale and purpose for receiving the data that is considered relatively reasonable by the authors (e.g., to re-analyze a published statistical analysis).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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