Brief Smartphone Treatment Study

Generalized Anxiety Disorder Clinical Trial

Official title:

Brief Smartphone Treatment Study for Anxiety and Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04846777
• Other study ID #: STUDY00010664
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2018
• Est. completion date: July 31, 2023

Study information

• Verified date: April 2022
• Source: Penn State University
• Contact: Nur Hani Zainal, M.S.
• Phone: 917-767-7088
• Email: nvz5057[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Little is known about whether and how brief mindfulness therapies yield clinically beneficial effects. This gap exists despite the rapid growth of smartphone mindfulness applications and presence of mental health treatment gap. Specifically, no prior brief, smartphone mindfulness ecological momentary intervention (MEMI) has targeted generalized anxiety disorder (GAD). Moreover, although theories propose that mindfulness intervention can boost attentional control (AC), executive functioning (EF), perspective-taking, and social cognition skills they have largely gone untested. Thus, this randomized controlled trial (RCT) aims to address these gaps by assessing the efficacy of a 14-day smartphone mindfulness EMI (vs. placebo). Participants with GAD will be randomly assigned to either MEMI or self-monitoring placebo (SMP). Those in treatment will exercise multiple core mindfulness strategies (open monitoring, acceptance, attending to small moments, slowed rhythmic diaphragmatic breathing). Also, those in MEMI will be reminded before bedtime that mindfulness is a lifelong practice. Comparatively, participants assigned to SMP will only be prompted to practice self-monitoring. They will notice their thoughts, rate any distress associated with them, and will not be taught any mindfulness strategies. All prompts will occur 5 times a day, for 14 consecutive days. They will complete self-reports and neuropsychological assessments at pre-, post-, and 1-month follow-up. Multilevel modeling analyses will determine if treatment (vs. self-monitoring placebo (SMP)) produces substantially larger reductions in trait worry and negative perseverative cognitions as well as steeper increases in AC and EF (inhibition, set-shifting, working memory updating). In addition, the investigators hypothesized that MEMI (vs. SMP) would lead to greater increases in performance-based and self-reported trait mindfulness, empathy, and perspective taking. Findings will advance understanding of the efficacy of unguided, technology-assisted, brief mindfulness in a clinical sample.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Presence of Generalized Anxiety Disorder based on the Generalized Anxiety Disorder Questionnaire-IV self-report and Mini International Neuropsychiatric Interview

• Current student at the Pennsylvania State University or a community-dwelling adult who expressed interest to participate through the PSU StudyFinder portal

• Expressed interest to seek treatment

• Currently not receiving treatment from a mental health professional

• Able to provide consent

• Proficient in English

Exclusion Criteria:

• Below age 18

• Failure to meet any of above inclusion criteria

• Participant currently undergoing

• Presence of suicidality, mania, psychosis, or substance use disorders

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Device:
• Mindfulness ecological momentary intervention
Access to a smartphone-delivered mindfulness ecological momentary intervention with the Personal Analytics Companion (PACO) app that regularly prompts participants to practice various mindfulness skills at 5 preset times each day.
• Self-monitoring placebo
Access to a smartphone-delivered self-monitoring placebo with the PACO app that regularly prompts participants to practice self-monitoring at 5 preset times each day.

Locations

Country	Name	City	State
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mental health disorder screening measures	Generalized anxiety disorder assessed using the Generalized Anxiety Disorder Questionnaire-IV (possible score range = 0 to 14). Higher score indicate worse outcome. Mental health disorders (generalized anxiety disorder, generalized anxiety disorder, major depressive disorder, manic and hypomanic episodes, agoraphobia, panic disorder, post-traumatic stress disorder, alcohol use disorder, substance use disorder, anorexia nervosa, bulimia nervosa, binge eating disorder), as well as rule out organic, drug, or medical causes of mental health problems were determined with the ADIS-5 (Brown & Barlow, 2014). Higher score indicate worse outcome.	Baseline
Primary	Change from Baseline Generalized Anxiety Disorder Symptoms at 14-Day Post-Treatment	Generalized Anxiety Disorder Questionnaire-IV (GAD-Q-IV) with categorical ('Yes' for presence and 'No' for absence) and continuous response formats (0 = not at all to 8 = very severely) (Newman et al., 2002) (Item 1 to Item 14 self-report; possible range = 0-12). Generalized Anxiety Disorder Questionnaire-Dimensional (Item 15 to Item 30) with consistent continuous 8-point Likert scale response formats that measures the frequency, intensity, uncontrollability, and degree of excessive worry (e.g., 0 = Always in control to 8 = Never in control) (Newman et al.) (possible range = 0-128). Larger reduction in score denote better outcome.	Baseline to 14-Day Post-Treatment
Primary	Change from Baseline Generalized Anxiety Disorder Symptoms at 6-Week Post-Randomization	Generalized Anxiety Disorder Questionnaire-IV (GAD-Q-IV) with categorical ('Yes' for presence and 'No' for absence) and continuous response formats (0 = not at all to 8 = very severely) (Newman et al., 2002) (Item 1 to Item 14 self-report; possible range = 0-12). Generalized Anxiety Disorder Questionnaire-Dimensional (Item 15 to Item 30) with consistent continuous 8-point Likert scale response formats that measures the frequency, intensity, uncontrollability, and degree of excessive worry (e.g., 0 = Always in control to 8 = Never in control) (Newman et al.) (possible range = 0-128). Larger reduction in score denote better outcome.	Baseline to 6-Week Post-Randomization
Primary	Change from Baseline Perseverative Cognitions at 14-Day Post-Treatment	The 45-item PCQ assessed perseverative cognitive traits linked to anxiety, depressive, and obsessive-compulsive symptoms. Respondents endorsed on a 6-point Likert scale (0 = strongly disagree to 5 = strongly agree). Further, the PCQ-45 comprised six factors: dwelling on the past; expecting the worst; lack of controllability; thoughts discrepant with ideal self; preparing for the future; searching for causes and meanings. Additionally, the PCQ had strong two-week retest reliability, discriminant validity, and convergent validity (Szkodny & Newman, 2019). A total score for PCQ was computed by summing the mean scores from each subscale (total possible score = 0-30). Larger reduction in score denote better outcome.	Baseline to 14-Day Post-Treatment
Primary	Change from Baseline Perseverative Cognitions at 6-Week Post-Randomization	The 45-item PCQ assessed perseverative cognitive traits linked to anxiety, depressive, and obsessive-compulsive symptoms. Respondents endorsed on a 6-point Likert scale (0 = strongly disagree to 5 = strongly agree). Further, the PCQ-45 comprised six factors: dwelling on the past; expecting the worst; lack of controllability; thoughts discrepant with ideal self; preparing for the future; searching for causes and meanings. Additionally, the PCQ had strong two-week retest reliability, discriminant validity, and convergent validity (Szkodny & Newman, 2019). A total score for PCQ was computed by summing the mean scores from each subscale (total possible score = 0-30). Larger reduction in score denote better outcome.	Baseline to 6-Week Post-Randomization
Secondary	Change from Baseline Depression Symptom Severity at 14-Day Post-Treatment	Beck Depression Inventory (Beck, Steer, & Brown, 1996) (21 of 21 items; self-report; possible range = 0-63). Larger reduction in score denote better outcome.	Baseline to 14-Day Post-Treatment
Secondary	Change from Baseline Depression Symptom Severity at 6-Week Post-Randomization	Beck Depression Inventory (Beck, Steer, & Brown, 1996) (21 of 21 items; self-report; possible range = 0-63). Larger reduction in score denote better outcome.	Baseline to 6-Week Post-Randomization
Secondary	Change from Baseline Attentional Control at 14-Day Post-Treatment	Attentional Control Questionnaire (Derryberry & Reed, 2002) (21 of 21 items; self-report; possible range = 0-60). Larger reduction in score denote better outcome.	Baseline to 14-Day Post-Treatment
Secondary	Change from Baseline Attentional Control at 6-Week Post-Randomization	Attentional Control Questionnaire (Derryberry & Reed, 2002) (21 of 21 items; self-report; possible range = 0-60). Larger reduction in score denote better outcome.	Baseline to 6-Week Post-Randomization
Secondary	Change from Baseline Working Memory at 14-Day Post-Treatment	Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV; Wechsler, 2008) (21 of 21 items; self-report; possible range = 0-78). Larger increase in score denote better outcome.	Baseline to 14-Day Post-Treatment
Secondary	Change from Baseline Working Memory at 6-Week Post-Randomization	Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV; Wechsler, 2008) (21 of 21 items; self-report; possible range = 0-78). Larger increase in score denote better outcome.	Baseline to 6-Week Post-Randomization
Secondary	Change from Baseline Set-Shifting at 14-Day Post-Treatment	Trail Making Test Part A and Part B (TMT-A and B; Strauss, Sherman, & Spreen, 2006) (2 of 2 items; self-report; possible range = 0-480). Larger reduction in score denote better outcome.	Baseline to 14-Day Post-Treatment
Secondary	Change from Baseline Set-Shifting at 6-Week Post-Randomization	Trail Making Test Part A and Part B (TMT-A and B; Strauss, Sherman, & Spreen, 2006) (2 of 2 items; self-report; possible range = 0-480). Larger reduction in score denote better outcome.	Baseline to 6-Week Post-Randomization
Secondary	Change from Baseline Inhibitory Control at 14-Day Post-Treatment	Color-Word Interference Test response time (Delis, Kaplan, & Kramer, 2001) (1 of 4 items; self-report; possible range = 0-960). Larger reduction in score denote better outcome.	Baseline to 14-Day Post-Treatment
Secondary	Change from Baseline Inhibitory Control at 6-Week Post-Randomization	Color-Word Interference Test response time (Delis, Kaplan, & Kramer, 2001) (1 of 4 items; self-report; possible range = 0-960). Larger reduction in score denote better outcome.	Baseline to 6-Week Post-Randomization
Secondary	Change from Baseline Verbal Fluency at 14-Day Post-Treatment	Phonemic cue; category fluency; switching fluency (Delis, Kaplan, & Kramer, 2001) (3 of 3 items; self-report; possible range = 0-240). Larger increase in score denote better outcome.	Baseline to 14-Day Post-Treatment
Secondary	Change from Baseline Verbal Fluency at 6-Week Post-Randomization	Phonemic cue; category fluency; switching fluency (Delis, Kaplan, & Kramer, 2001) (3 of 3 items; self-report; possible range = 0-240). Larger increase in score denote better outcome.	Baseline to 6-Week Post-Randomization
Secondary	Change from Baseline Empathy at 14-Day Post-Treatment	Bell-Lysaker Emotion Recognition Test (BLERT; Bryson, Bell, & Lysaker, 1997) (21 of 21 items; self-report; possible range = 0-21). Larger increase in score denote better outcome.	Baseline to 14-Day Post-Treatment
Secondary	Change from Baseline Empathy at 6-Week Post-Randomization	Bell-Lysaker Emotion Recognition Test (BLERT; Bryson, Bell, & Lysaker, 1997) (21 of 21 items; self-report; possible range = 0-21). Larger increase in score denote better outcome.	Baseline to 6-Week Post-Randomization
Secondary	Change from Baseline Interpersonal Reactivity Traits at 14-Day Post-Treatment	Interpersonal Reactivity Index (IRI; Davis, 1980) (28 of 28 items; self-report; possible range = 0-140). Larger increase in score denote better outcome.	Baseline to 14-Day Post-Treatment
Secondary	Change from Baseline Interpersonal Reactivity Traits at 6-Week Post-Randomization	Interpersonal Reactivity Index (IRI; Davis, 1980) (28 of 28 items; self-report; possible range = 0-140). Larger increase in score denote better outcome.	Baseline to 6-Week Post-Randomization
Secondary	Change from Baseline Trait Mindfulness at 14-Day Post-Treatment	Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2008) (28 of 28 items; self-report; possible range = 0-395). Larger increase in score denote better outcome.	Baseline to 14-Day Post-Treatment
Secondary	Change from Baseline Trait Mindfulness at 6-Week Post-Randomization	Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2008) (28 of 28 items; self-report; possible range = 0-395). Larger increase in score denote better outcome.	Baseline to 6-Week Post-Randomization