SkillJoy Clinical Trial
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Behavioral: SkillJoy InterventionBehavioral: Active Self-Monitoring Control Intervention
- Registration Number
- NCT05040061
- Lead Sponsor
- Skidmore College
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SkillJoy Intervention 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 Self-Monitoring Control Intervention 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.
- Primary Outcome Measures
Name Time Method Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Savoring the Moment Subscale of the Savoring Beliefs Inventory 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.
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Positive and Negative Affect Schedule, Expanded Form: Joviality Scale 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.
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Penn State Worry Questionnaire 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.
- Secondary Outcome Measures
Name Time Method Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Prioritizing Positivity Scale 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.
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in Responses to Positive Affect Scale: Dampening Subscale 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.
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Life Orientation Test - Revised 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.
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Beck Depression Inventory II 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.
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in Contrast Avoidance Questionnaire - Worry 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.
Trial Locations
- Locations (1)
Skidmore College
🇺🇸Saratoga Springs, New York, United States