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SkillJoy Clinical Trial (SkillJoy)

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SkillJoy Intervention
Active Self-Monitoring Control Intervention
Sponsored by
Skidmore College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Worry, Savoring, Ecological Momentary Intervention, Generalized Anxiety Disorder, Positive Emotion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Skidmore College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SkillJoy Intervention

Active Self-Monitoring Control Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Penn State Worry Questionnaire
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.
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Positive and Negative Affect Schedule, Expanded Form: Joviality Scale
An 8-item measure of positive emotions. Min. score of 8 and maximum score of 40. Increases in scores suggest a better outcome.
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Savoring the Moment Subscale of the Savoring Beliefs Inventory
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.

Secondary Outcome Measures

Pre- to Post-Trial and Pre-Trial to Follow-Up Change in Responses to Positive Affect Scale: Dampening Subscale
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.
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Prioritizing Positivity Scale
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.
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Life Orientation Test - Revised
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.
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Beck Depression Inventory II
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.
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in Contrast Avoidance Questionnaire - Worry
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.

Full Information

First Posted
August 24, 2021
Last Updated
September 1, 2021
Sponsor
Skidmore College
Collaborators
Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT05040061
Brief Title
SkillJoy Clinical Trial
Acronym
SkillJoy
Official Title
SkillJoy Randomized Controlled Trial: Testing a Smartphone Intervention for Anxiety and Reinforcement
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 17, 2018 (Actual)
Primary Completion Date
December 7, 2019 (Actual)
Study Completion Date
December 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Skidmore College
Collaborators
Penn State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Worry, Savoring, Ecological Momentary Intervention, Generalized Anxiety Disorder, Positive Emotion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants screened to select-in GAD with a clinical interview are randomly assigned to either a savoring treatment intervention condition (SkillJoy) or an active treatment control condition emphasizing self-monitoring.
Masking
Participant
Masking Description
Participant were not made aware of the existence of the condition to which they were not assigned, nor the nature of that condition.
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SkillJoy Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Self-Monitoring Control Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SkillJoy Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Self-Monitoring Control Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Penn State Worry Questionnaire
Description
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.
Time Frame
8 day post-trial; 30th day follow-up
Title
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Positive and Negative Affect Schedule, Expanded Form: Joviality Scale
Description
An 8-item measure of positive emotions. Min. score of 8 and maximum score of 40. Increases in scores suggest a better outcome.
Time Frame
8 day post-trial; 30th day follow-up
Title
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Savoring the Moment Subscale of the Savoring Beliefs Inventory
Description
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.
Time Frame
8 day post-trial; 30th day follow-up
Secondary Outcome Measure Information:
Title
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in Responses to Positive Affect Scale: Dampening Subscale
Description
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.
Time Frame
8 day post-trial; 30th day follow-up
Title
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Prioritizing Positivity Scale
Description
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.
Time Frame
8 day post-trial; 30th day follow-up
Title
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Life Orientation Test - Revised
Description
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.
Time Frame
8 day post-trial; 30th day follow-up
Title
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Beck Depression Inventory II
Description
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.
Time Frame
8 day post-trial; 30th day follow-up
Title
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in Contrast Avoidance Questionnaire - Worry
Description
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.
Time Frame
5 day mid-trial; 8 day post-trial; 30th day follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Skidmore College
City
Saratoga Springs
State/Province
New York
ZIP/Postal Code
12866
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

SkillJoy Clinical Trial

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