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| Name | Class |
|---|---|
| University of Exeter | OTHER |
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The goal of this study is to understand why certain treatments help people reduce repetitive negative thinking (RNT), which is common in many mental health problems. We want to:
The main result we will look at is how much a person's repetitive negative thought patterns change from the start of the study to the end of treatment (16 weeks). We will measure this using the Perseverative Thinking Questionnaire at baseline and week 16.
Participants in this study will be randomly assigned to one of 16 different treatment groups. Each group will get a different mix of 1-5 tools or strategies taken from Rumination-Focused Cognitive Behavioral Therapy (RF-CBT).
All participants, regardless of their treatment assignment, will get a basic set of lessons about repetitive negative thinking (RNT) and how CBT can help. This means every participant gets therapeutic support.
Participants will use a digital therapy program through the MyDataHelps app. The CBT lessons are available in English or Spanish, according to the participant's preference. Each participant will also be offered 3-6 meetings with a coach from our team, to review the lessons and tools in the digital therapy program. It is expected that the digital therapy program and coaching sessions will be completed within 4 months on study. Once 4 months have passed since their start on study, participants are asked to complete online questionnaires that will measure their recent symptom experiences. Participants are then asked to complete these questionnaires again 1 year after starting on study. These questionnaires are used to measure changes in symptom experiences from baseline (before starting the digital therapy program).
In addition to the primary goals listed in the brief summary, this study also aims to look at the following:
d) Who benefits most from which components, so therapy can be more personalized in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychoeducation Only | Active Comparator | Participants receive only core psychoeducation without any additional RF-CBT components. |
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| Be Specific | Experimental | Participants receive training in increasing specificity and concreteness ("Be Specific") in addition to standard psychoeducation. |
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| Be Kind | Experimental | Participants receive training in self-compassion ("Be Kind") in addition to standard psychoeducation. |
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| Break Habit | Experimental | Participants receive training in breaking the habit of repetitive negative thinking ("Break Habit") in addition to standard psychoeducation. |
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| Be Present | Experimental | Participants receive training in absorption in direct experience ("Be Present") in addition to standard psychoeducation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Be Specific | Behavioral | Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style. Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity. Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Perseverative Thinking Questionnaire score from baseline to post-intervention | Change in repetitive negative thought as indexed by the Perseverative Thinking questionnaire | Baseline, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GAD-7 score from baseline to post-intervention | Change in anxiety measured with GAD-7 | Baseline, 16 weeks & 52 weeks |
| Change in PHQ-9 score from baseline to post-intervention | Change in depression measured with PHQ-9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial Valley College | Imperial | California | 92251 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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Participants will be randomized in a factorial design to one of 16 conditions for treatment, each consisting of 1-5 treatment components from Rumination-Focused CBT (RF-CBT). All participants will be exposed to a default core common content (e.g. psychoeducation about RNT and CBT approaches to coping) such that all participants receive a minimal-level intervention.
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| Be Specific + Be Kind | Experimental | Participants receive training in both specificity/concreteness and self-compassion in addition to standard psychoeducation. |
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| Be Specific + Be Present | Experimental | Participants receive training in both specificity/concreteness and absorption in direct experience in addition to standard psychoeducation. |
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| Be Kind + Be Present | Experimental | Participants receive training in both self-compassion and absorption in direct experience in addition to standard psychoeducation. |
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| Be Specific + Be Kind + Be Present | Experimental | Participants receive training in specificity/concreteness, self-compassion, and absorption in direct experience in addition to standard psychoeducation. |
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| Break Habit + Be Specific | Experimental | Participants receive training in both breaking the habit of RNT and increasing specificity/concreteness in addition to standard psychoeducation. |
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| Break Habit + Be Kind | Experimental | Participants receive training in both breaking the habit of RNT and self-compassion in addition to standard psychoeducation. |
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| Break Habit + Be Specific + Be Kind | Experimental | Participants receive training in breaking the habit of RNT, specificity/concreteness, and self-compassion in addition to standard psychoeducation. |
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| Break Habit + Be Present | Experimental | Participants receive training in both breaking the habit of RNT and absorption in direct experience in addition to standard psychoeducation. |
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| Break Habit + Be Specific+ Be Present | Experimental | Participants receive training in breaking the habit of RNT, specificity/concreteness, and absorption in direct experience in addition to standard psychoeducation. |
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| Break Habit + Be Kind + Be Present | Experimental | Participants receive training in breaking the habit of RNT, self-compassion, and absorption in direct experience in addition to standard psychoeducation. |
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| ALL | Experimental | Participants receive training in all four RF-CBT components: breaking the habit of RNT, specificity/concreteness, self-compassion, and absorption in direct experience; in addition to standard psychoeducation. |
|
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| Be Kind | Behavioral | Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion. Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT. Training self-compassion skills to counter harsh self-evaluation and support emotional regulation. |
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| Be Present | Behavioral | Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience. Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption. Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience. |
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| Break Habit | Behavioral | Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior. Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits. Training new behavioral and cognitive routines to replace automatic RNT patterns. |
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| Psychoeducation | Behavioral | Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs. Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences. This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding. |
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| Baseline, 16 weeks & 52 weeks |
| Change in WEMWBS from baseline to post-intervention | Change in mental wellbeing measured with WEMWBS (Warwick-Edinburgh Mental Wellbeing Scale short-form) | Baseline, 16 weeks & 52 weeks |
| Change in RRS-Brooding subscale from baseline to post-intervention | Change in levels of rumination measured with RRS-Brooding subscale | Baseline, 16 weeks & 52 weeks |
| Change in PSWQ score from baseline to post-intervention | Change in levels of worry measured with PSWQ (Penn State Worry Questionnaire short-form) | Baseline, 16 weeks & 52 weeks |
| Change in WSAS score from baseline to post-intervention | Change in social functioning measured with WSAS (Work and Social Adjustment Scale) | Baseline, 16 weeks & 52 weeks |
| Change in EMA from baseline to post-intervention | Change in repetitive negative thought (RNT) in everyday life measured with ecological momentary assessment (EMA) (aggregrate 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). This provides an ecologically valid measure, in the real-world, of extent of RNT and how it changes pre-to-post intervention. | Baseline, 16 weeks |