NCT Number: NCT04846777
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
University Park, Pennsylvania, 16802, United States
Location status: Recruiting
Michelle G. Newman, Ph.D.
CONTACT
Michelle G. Newman, Ph.D.
SUB_INVESTIGATOR
Nur Hani Zainal, M.S.
CONTACT
Nur Hani Zainal, M.S.
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline
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.
Contact information is provided by the study sponsor or research team.
Michelle G. Newman, Ph.D.
CONTACT
Nur Hani Zainal, M.S.
CONTACT
Penn State University
Other
Brief Smartphone Treatment Study for Anxiety and Depression
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