Repetitive negative thought (overthinking, rumination, worry) Mental and Behavioural Disorders
Conditions
Interventions
If the participant has completed their baseline questionnaires and 60% of the mPath prompt questions within the specified time limits, they will proceed to be automatically randomised via the study da
Sponsors
University of Exeter
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Participants must satisfy ALL of the following criteria to be enrolled in the study, and will be excluded in sequence if an individual does not meet a criterion during screening (to minimise participant burden): 1. Lives in UK or USA 2. Aged 18 years and over 3. Access to a suitable smartphone/device to use the m-Path app and MyDataHelps intervention (i.e. MyDataHelps requires iOS 16.4 or later. iOS 16.4 is compatible with all iPhone models starting from the iPhone 8 and later. For Android devices, MyDataHelps requires Android version 8.0 or higher.) 4. Elevated RNT based on the following assessment scores – scoring in top quartile in one and in top tercile for the other based on prior studies: 4.1. RRS brooding score above 12 (top quartile) and PSWQ-short form score above 24 (top tercile) OR 4.2. RRS brooding score above 11 (top tercile) and PSQW-short form score above 26 (top quartile)
Exclusion criteria
Exclusion criteria: Participants who self-report meeting ANY of the following criteria at time of recruitment will be excluded from study participation: 1. Concurrent psychotherapy 2. Current self-reported diagnosis of any of the following conditions, including receiving or waiting for treatment: 2.1. Alcohol abuse/dependence 2.2. Substance abuse/dependence 3. Self-reported diagnosis of current or history of bipolar disorder or psychosis at any time 4. Taking antidepressants or anxiolytic medications at a stable dose for less than six weeks 5. Severe post-traumatic stress disorder (PTSD, assessed as a score of 17 or higher in total for the first six questions AND a score of 2 or higher on the seventh question of the adapted International Trauma Questionnaire; ITQ) 6. Suicidal thoughts* and self-harm assessed by a combination of PHQ-9 question 9 score of 1 or higher and a yes to question R1a and/or R1B, and a yes to either question R2 and/or R3 (detailed below): R1a = In the last 2 weeks have you been experiencing regular thoughts about suicide? R1b = In the last 2 weeks have you been experiencing regular thoughts about self-harm? R2 = In the last 2 weeks have you had any intention to hurt or kill yourself? R3 = In the last 2 weeks have you made any plans to harm yourself or end your life?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RNT as indexed by the Perseverative Thinking Questionnaire from baseline to post-treatment (16 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcomes will be measured using standardised validated measures at baseline, and post- treatment at 16 weeks and 52 weeks post-randomisation via participant survey on REDCap: 1. Anxiety measured with General Anxiety Disorder-7 (GAD-7) 2. Depression measured with Patient Health Questionnaire-9 (PHQ-9) 3. Mental wellbeing measured with Warwick-Edinburgh Mental Wellbeing Scale Short-form (WEMWBS) 4. Levels of rumination measured with RRS-Brooding subscale 5. Levels of worry measured with Penn State Worry Questionnaire –short-form (PSWQ) 6. Social functioning measured with Work and Social Adjustment Scale (WSAS) The following secondary outcome will only be measured at baseline and at 16 weeks post-randomisation (captured by the mPath app): 7. Repetitive negative thought (RNT) in everyday life measured with EMA (aggregate person-level ratings of RNT across 10 day period; variability of RNT; relationship of RNT to mood state & contextual events; automaticity of RNT, based on EMA items) We will also assess incidence of major depressive episodes and generalized anxiety disorder across the 12-month follow-up using standardized structured online measures (adapted lifetime history of depression and anxiety disorders (LIDAS) for depression, adapted GAD for anxiety), enabling us to test which factors have long-term effects on RNT and on the prevention of first incidence or recurrence of episodes of depression and anxiety, providing direct data to inform transformation of early interventions. | — |
Countries
England, United Kingdom, United States of America
Outcome results
None listed