Clinical trial NCT05040061: SkillJoy Clinical Trial
Official title: SkillJoy Randomized Controlled Trial: Testing a Smartphone Intervention for Anxiety and Reinforcement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Worry
Savoring
Ecological Momentary Intervention
Generalized Anxiety Disorder
Positive Emotion
Lead sponsor: Skidmore College
Sponsor class: OTHER
Collaborators: name: Penn State University
First posted: 2021-09-10
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Penn State Worry Questionnaire
timeFrame: 8 day post-trial; 30th day follow-up
measure: Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Positive and Negative Affect Schedule, Expanded Form: Joviality Scale
timeFrame: 8 day post-trial; 30th day follow-up
measure: Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Savoring the Moment Subscale of the Savoring Beliefs Inventory
timeFrame: 8 day post-trial; 30th day follow-up
Secondary outcomes:
measure: Pre- to Post-Trial and Pre-Trial to Follow-Up Change in Responses to Positive Affect Scale: Dampening Subscale
timeFrame: 8 day post-trial; 30th day follow-up
measure: Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Prioritizing Positivity Scale
timeFrame: 8 day post-trial; 30th day follow-up
measure: Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Life Orientation Test - Revised
timeFrame: 8 day post-trial; 30th day follow-up
measure: Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Beck Depression Inventory II
timeFrame: 8 day post-trial; 30th day follow-up
measure: Pre- to Post-Trial and Pre-Trial to Follow-Up Change in Contrast Avoidance Questionnaire - Worry
timeFrame: 5 day mid-trial; 8 day post-trial; 30th day follow-up
Other outcomes:
Locations:
city: Saratoga Springs
country: United States
facility: Skidmore College
state: New York
Study officials:
References: