SkillJoy Clinical Trial

NCT05040061 | Completed

• 1 other identifier: 2108-974
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Keywords

Worry; Savoring; Ecological Momentary Intervention; Generalized Anxiety Disorder; Positive Emotion

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  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 Outcomes (5)

• 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

• Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Prioritizing Positivity Scale

  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

  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

  8 day post-trial; 30th day follow-up

• 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

Study Arms (2)

SkillJoy Intervention

EXPERIMENTAL

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

Active Self-Monitoring Control Intervention

ACTIVE COMPARATOR

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

Interventions

SkillJoy Intervention BEHAVIORAL

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.

SkillJoy Intervention

Active Self-Monitoring Control Intervention BEHAVIORAL

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.

Active Self-Monitoring Control Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Skidmore College: lead
• Penn State University: collaborator

Study Sites (1)

Skidmore College

Saratoga Springs, New York, 12866, United States

Location

Related Publications (2)

• LaFreniere LS, Newman MG. Savoring changes novel positive mindset targets of GAD treatment: Optimism, prioritizing positivity, kill-joy thinking, and worry mediation. Behav Res Ther. 2024 Jun;177:104541. doi: 10.1016/j.brat.2024.104541. Epub 2024 Apr 16.

  PMID: 38640622 DERIVED

• LaFreniere LS, Newman MG. Upregulating positive emotion in generalized anxiety disorder: A randomized controlled trial of the SkillJoy ecological momentary intervention. J Consult Clin Psychol. 2023 Jun;91(6):381-387. doi: 10.1037/ccp0000794. Epub 2023 Jan 30.

  PMID: 36716146 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant were not made aware of the existence of the condition to which they were not assigned, nor the nature of that condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 10, 2021
• Study Start: May 17, 2018
• Primary Completion: December 7, 2019
• Study Completion: December 7, 2019
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available at the time of reasonable request.
• 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).

Locations

US (1)