StayFine: Personalised Relapse Prevention of Anxiety and Mood Disorders in Youths
Study Details
Study Description
Brief Summary
The current study examines the effectiveness of the StayFine app for relapse prevention of anxiety or depressive disorders in youth using a randomized controlled trial. In addition, ecological momentary assessment (EMA) is used to explore fluctuations in emotions, psychological factors as predictor of the intervention effect and potential differential mechanisms of change. A total of 254 healthy youths remitted from an anxiety and/or depressive disorder, aged 13-21 years old, will be recruited for the study. Participants will be randomized to either 1) use the StayFine app exclusively for monitoring, or 2) use the StayFine app for monitoring and interventions supported by an expert patient. Stratification blocks are of random size and depend on previous episodes (1/2/3 or more) and previous treatment (yes/no). The intervention is based on the well-established Preventive Cognitive Therapy (PCT) for relapse prevention for adults and Cognitive Behavioral therapy adapted for the relapse prevention phase, both supplemented for anxiety and adolescents. In both conditions adolescents monitor their symptoms five times in three years and feedback and treatment advice is given in case of relapse.
The primary outcome will be time to relapse. Secondary outcomes are (core) symptoms of depression and anxiety, number and duration of relapses, global functioning and quality of life. Mediators and moderators will be explored. Exploratory endpoints are monitoring and wearable outcomes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study was previously pre-registered in the Netherlands Trial Registry (NTR) on December 15th 2019 with number NL8237. Enrollment started December 16th 2019. This new registry is made because an error was detected in the eligibility criteria listed on the NTR. That registry is taken offline and cannot be updated. Therefore the investigators registered the same study again, but now with updates to correct the wrongly entered information. The previously registered information is available through: https://trialsearch.who.int/Trial2.aspx?TrialID=NL8237
The eligibility criteria and outcomes as defined in the current registry of ClinicalTrials.gov were used from the start of the study and have not been changed during enrollment and recruitment.
In the previous registry the use of a chat-group was mentioned in the intervention. Due to feasibility/planning issues, this was never implemented and therefore this is left out of the current registration. The outcome 'heart rate' is left out as well, because this outcome was not used after a switch in the wearable that measures activity level. Both changes were made before the first participant was enrolled in the study.
The StayFine app runs on the Minddistrict web-based platform that has a CE-certificate. It states that for the Minddistrict platform is in confirmatory with all relevant provisions of Medical Devices Directive 93/42/EEC in conjunction with the following relevant specifications: EN62304:2006+AC:2008; EN-ISO 14971:2012; EN 82304-1:2017.
The StayFine app runs on the Minddistrict web-based platform that has a CE-certificate. It states that for the Minddistrict platform is in conformity with all relevant provisions of Medical Devices Directive 93/42/EEC in conjunction with the following relevant specifications: EN62304:2006+AC:2008; EN-ISO 14971:2012; EN 82304-1:2017.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Monitoring + Intervention modules Monitoring: Ecological Momentary Assessment (EMA) of affect, thoughts and social company. Optionally with a wearable to measure activity level. Six times per day for two weeks. Timepoints: T0-T4. Intervention modules: StayFine guided app-based personalised intervention modules. Each individual receives six of eight modules of which three are mandatory and three others are selected based on a personalization procedure. Time point: after T0 over the course of three months. |
Behavioral: StayFine guided app-based personalised intervention modules
Participants work on guided app-based personalised intervention modules in the StayFine app over the course of three months. The modules are selected by the participant based on shared decision making and a personalized advice. The intervention is based on Preventive Cognitive Therapy (PCT) with elements of Cognitive Behavioral Therapy (CBT) and Positive Psychology. Modules are: psycho education (mandatory), cognitive restructuring (mandatory), positive affect, behavioral activation, exposure, wellness, sleep and a relapse prevention plan (mandatory).
Behavioral: StayFine app-based monitoring
Monitoring six times per day for two weeks in the StayFine app.
|
| Active Comparator: Monitoring Monitoring:Ecological Momentary Assessment (EMA) of affect, thoughts and social company. Optionally with a wearable to measure activity level. Six times per day for two weeks. Timepoints: T0-T4. |
Behavioral: StayFine app-based monitoring
Monitoring six times per day for two weeks in the StayFine app.
|
Outcome Measures
Primary Outcome Measures
- Time to anxiety and/or depressive relapse [up to 36 months (planned: 0, 4, 12, 24, 36 months)]
Time to anxiety and/or depressive relapse over 36 months as assessed by a semi-structured interview: the Kiddie Schedule for Affective Disorders and Schizophrenia - lifetime version (K-SADS-PL DSM-5).
Secondary Outcome Measures
- Number of relapses [up to 36 months (planned: 0, 4, 12, 24, 36 months)]
Measured during each semi-structured interview (K-SADS-PL DSM-5). An extra interview may be scheduled if relapse is expected.
- Duration of relapse in days [up to 36 months (planned: 0, 4, 12, 24, 36 months)]
Measured during each semi-structured interview (K-SADS-PL DSM-5). An extra interview may be scheduled if relapse is expected.
- Global Assessment of Functioning Scale (GAF) [up to 36 months (planned: 0, 4, 12, 24, 36 months)]
Global functioning (0-100). Higher scores mean a better outcome. Measured during each semi-structured interview. An extra interview may be scheduled if relapse is expected.
- Revised Children's Anxiety and Depression Scale (RCADS) [up to 36 months (planned: 0, 4, 12, 24, 36 months)]
Anxiety symptoms (0-3 for 31 items). Higher scores mean a worse outcome. Adapted self-report questionnaire RCADS (only including anxiety subscales, total 31 items).
- Beck Depression Inventory (BDI) [up to 36 months (planned: 0, 4, 12, 24, 36 months)]
Depressive symptoms (0-3 for 21 items). Higher scores mean a worse outcome.
- Dutch version of the EuroQol Questionaire (EQ-5D-Y) [0, 4, 12, 24, 36 months]
Quality of life (1-3 for 5 items). Higher scores mean a worse outcome. Quality of life (0-100). Higher scores mean a better outcome.
Other Outcome Measures
- Descriptives [0, 4, 12, 24, 36 months]
Age, ethnicity, education level, living situation, previous episodes, previous care, comorbidity, negative life events
- Ecological Momentary Assessment (affect, thoughts and social company) [0, 4, 12, 24, 36 months]
StayFine monitoring outcomes (exploratory endpoint): anxious, sad, angry, stressed, fatigue, experiential avoidance, behavioral avoidance, loneliness, activity costs energy (0-100). Higher scores mean a worse outcome. Energetic, relaxed, enthusiastic, happy, pleasurable activity (0-100). Higher scores mean a better outcome. Social company (yes/no).
- Wearable data (physical activity) [0, 4, 12, 24, 36 months]
StayFine monitoring outcomes (exploratory endpoint): the wearable continuously measures acceleration (i.e. movement, vibration and orientation changes in all 3-axes (x,y,z), converted to score estimates of physical activity). The unit of measure is mg (gravitational acceleration). Higher scores mean more activity.
- Wearable data (diurnal patterns) [0, 4, 12, 24, 36 months]
StayFine monitoring outcomes (exploratory endpoint): the wearable continuously measures acceleration (i.e. movement, vibration and orientation changes in all 3-axes (x,y,z), converted to score estimates of physical activity and sleep. This can be converted into diurnal patterns based on time of the day and amount of physical activity and sleep.
- Dysfunctional Attitude Scale-17 (DAS-17) [0, 4, 12, 24, 36 months]
Dysfunctional attitudes (1-7 for 17 items). Higher scores mean a worse outcome.
- Positive and negative affect scale (PANAS) [0, 4, 12, 24, 36 months]
Positive and negative affect (1-5 for 20 items). Higher scores on the 10 positive affect items mean a better outcome. Higher scores on the 10 negative affect items mean a worse outcome.
- Behavioral Activation for Depression Scale short form (BADS-SF) [0, 4, 12, 24, 36 months]
Behavioral Activation (1-7 for 9 items). High scores are consistent with the title of the subscales (e.g., high scores on activation mean more activation and thus a better outcome).
- Sleep Reduction Screening Questionnaire (SRSQ) [0, 4, 12, 24, 36 months]
Sleep (1-3 for 9 items). Higher scores mean a worse outcome.
- Perceived Stress Scale (PSS-10) [0, 4, 12, 24, 36 months]
Stress (0-4 for 10 items). Higher scores mean a worse outcome.
- Utrechtse Coping Lijst (UCL) [0, 4, 12, 24, 36 months]
Coping (1-4 for 47 items). Higher scores mean a better or worse outcome depending on the type of coping (7 in total). For maladaptive strategies higher scores mean a worse outcome, for adaptive strategies higher scores mean a better outcome.
- Brief Experiential Avoidance Questionnaire (BEAQ) [0, 4, 12, 24, 36 months]
Experiential Avoidance (1-6 for 15 items). Higher scores mean a worse outcome.
- Dutch Mental Health Continuum-Short Form (MHC-SF) [0, 4, 12, 24, 36 months]
Flourishing (0-5 for 14 items). Higher scores mean a better outcome.
- Adapted Multidimensional Scale of Perceived Social Support (MSPSS-N) [0, 4, 12, 24, 36 months]
Support (1-7 for 18 items). Higher scores mean a better outcome.
- System Usability Scale (SUS) [0, 4, 12, 24, 36 months]
Usability of StayFine app (1-5 for 10 items). Higher scores mean a better outcome.
- Service satisfaction scale (SSS) and 3 questions at the end of an intervention module [0, 4, 12, 24, 36 months]
Satisfaction with StayFine intervention modules measured using the SSS (1-4 for 4 items). Higher scores mean a better outcome. Satisfaction measured using two '0-100' questions at the end of an intervention module. Higher scores mean a better outcome. One open ended question.
- (Serious) adverse events [up to 36 months]
If the participants reports an adverse event, it will be registered. During each semi-structured interview, it will be asked as well.
- Patient Health Questionnaire for Depression and Anxiety (PHQ4) [0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 months]
A short 4-item screener for core symptoms of anxiety and depression is administered every three months and once extra after the first month (0-3 for 4 items).
Eligibility Criteria
Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria at entry of the study:
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Age 13-21 years
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Adolescents who do NOT meet criteria of a current anxiety disorder (separation -, social - or generalized anxiety disorder, specific phobia, panic disorder, agoraphobia) or depressive disorder (major depressive -, persistent depressive -, or disruptive mood dysregulation disorder) based on a semi-structured diagnostic interview (Kiddie Schedule for Affective Disorders and Schizophrenia - lifetime version (K-SADS-PL DSM-5)), but DO meet the criteria for at least one PREVIOUS episode of one or the combination of the above mentioned disorders
Exclusion Criteria:
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A potential subject who currently meets criteria of any of the following mental health problems will be excluded from participation in this study:
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Alcohol or drug misuse
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Previous hypomania and/or mania
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Bipolar disorder
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Previous and/or current psychotic episode
Other exclusion criteria include:
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Only in remission of another anxiety or mood disorder than mentioned above at the inclusion criteria, namely premenstrual dysphoric disorder, depressive disorder due to another medical condition, substance/medication-induced depressive disorder, other specified depressive disorder, unspecified depressive disorder, selective mutism, substance/medication-induced anxiety disorder or anxiety disorder due to another medical condition, other specified anxiety disorder, unspecified anxiety disorder
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only in remission of PTSD or OCD
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ongoing current treatment (more than twice a month) for a mental health disorder including those listed under the inclusion criteria
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no or insufficient mastery of the Dutch language.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GGZ Oost Brabant | Boekel | Netherlands |
Sponsors and Collaborators
- Ggz Oost Brabant
- University of Groningen
- Amsterdam UMC, location AMC
- Accare
- RINO ZUID
Investigators
- Principal Investigator: Yvonne Stikkelbroek, PhD, Ggz Oost Brabant
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 636310007