Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570694
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
RCT Protocol for OverThinking A Mobile EMI for Reducing Experiential Avoidance
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Mobile Ecological Momentary Intervention for Reducing Experiential Avoidance in the Context of Rumination Protocol for a Randomised-Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this trial is to examine whether a mobile app intervention for rumination can modify a maladaptive feature of repetitive negative thinking RNT - this is understood by the link between daily RNT and well-being depressive and anxiety symptoms
The main questions it aims to answer are
1 If the intervention can modify the maladaptive feature of repetitive negative thinking - the investigators anticipate the link between daily rumination and maladaptive outcomes poorer wellbeing higher depressiveanxious symptoms will be weaker in the intervention groups
2 By examining 1 above to confirm the role played by avoidance in repetitive negative thinking
3 By splitting the intervention condition into two groups one receiving concurrent support from a therapist one not to evaluate if interventions such as these might be enhanced by therapist support
4 To examine if the impact of the intervention on depressive and anxious symptoms might be mediated by changes in beliefs regarding emotions eg the valuation of negative emotions
Researchers will compare across four groups to examine the above effects
1 intervention condition therapist support 2 intervention condition no therapist support 3 Partial intervention daily sampling and emotion valuation questions 4 Control group only daily sampling questions
Participants will
Be requested to participate in a four-week intervention providing daily assessments of depressive and anxiety symptoms affect repetitive negative thinking and rumination outcomes
Use a mobile application during the intervention period which has been designed by the research team intervention groups or provide daily assessment scores only control groups
Be assessed at pre-intervention all groups post-intervention all groups 1-month follow-up all groups and 3-month follow-up intervention groups only
The main questions it aims to answer are
1 If the intervention can modify the maladaptive feature of repetitive negative thinking - the investigators anticipate the link between daily rumination and maladaptive outcomes poorer wellbeing higher depressiveanxious symptoms will be weaker in the intervention groups
2 By examining 1 above to confirm the role played by avoidance in repetitive negative thinking
3 By splitting the intervention condition into two groups one receiving concurrent support from a therapist one not to evaluate if interventions such as these might be enhanced by therapist support
4 To examine if the impact of the intervention on depressive and anxious symptoms might be mediated by changes in beliefs regarding emotions eg the valuation of negative emotions
Researchers will compare across four groups to examine the above effects
1 intervention condition therapist support 2 intervention condition no therapist support 3 Partial intervention daily sampling and emotion valuation questions 4 Control group only daily sampling questions
Participants will
Be requested to participate in a four-week intervention providing daily assessments of depressive and anxiety symptoms affect repetitive negative thinking and rumination outcomes
Use a mobile application during the intervention period which has been designed by the research team intervention groups or provide daily assessment scores only control groups
Be assessed at pre-intervention all groups post-intervention all groups 1-month follow-up all groups and 3-month follow-up intervention groups only
Detailed Description:
The trial aims to examine whether a mobile application-based intervention for experiential avoidance in the context of rumination can modify a maladaptive feature of repetitive negative thinking RNT - this is understood by the link between daily RNT and well-being depressive and anxiety symptoms
The main questions which the trial aims to answer are as follows
1 If the intervention can modify the maladaptive feature of repetitive negative thinking - the investigators anticipate the link between daily rumination and maladaptive outcomes poorer wellbeing higher depressiveanxious symptoms will be weaker in the intervention groups
2 By examining 1 above to confirm the role played by avoidance in repetitive negative thinking
3 By splitting the intervention condition into two groups one receiving concurrent support from a therapist one not to evaluate if interventions such as these might be enhanced by therapist support
4 To examine if the impact of the intervention on depressive and anxious symptoms might be mediated by changes in beliefs regarding emotions eg the valuation of negative emotions
Researchers will compare across four groups to examine the above effects
1 intervention condition therapist support 2 intervention condition no therapist support 3 Partial intervention daily sampling and emotion valuation questions 4 Control group only daily sampling questions
The trial comprises of a four-arm parallel group randomised-controlled trial RCT Participation lasts approximately 2 months including eligibility screening and random allocation to condition random number generator a four-week intervention period delivered via the mobile application and supplemented with daily assessments post-intervention assessments and 1-month follow-up wherein the app will remain available for self-directed use without daily sampling concluding with follow-up assessments and measurement of any engagement with the application during this period
At the point of 1-month follow-up participants previously allocated to the control groups will receive access to the application without the feature of daily sampling and will be provided with guidance on using the intervention content While a 3-month follow-up assessment of intervention participants is planned the 1-month interval allows for control participants to access intervention content without being subject to extensive waitlist delay Active control groups have been chosen to not artificially inflate comparisons with outcomes in the intervention conditions
Analysis
Analysis of changes in outcomes across pre- post- and follow-up-measures PTQ EBQ PBRS NBRS HADS CAQ and BEAQ across all four conditions will be conducted using mixed-design ANOVA
Additionally for all conditions multilevel models daily observations on level 1 nested in participants on level 2 will be used on daily sampling data to assess the links between avoidance and mood and between rumination and mood and to determine if each of these links is moderated by condition Participants respond to these items once daily in the evening in response an in-app reminder alert the time of the alert can be determined by the participant All daily sampling items have been provided in the Measures section
Mixed-design ANCOVA will be used for the two intervention groups to examine if time spent engaging with the application content acts as a covariate in intervention outcomes PTQ EBQ PBRS NBRS HADS CAQ and BEAQ
Finally ongoing development of the application will be assisted using in-app user-feedback data obtained via CORTO implementation three items with gather a combination of quantitative and qualitative data Lukka et al 2024 This data will be coded deductively using the process outlined by Saldana 2016 and using the four categories identified by Lukka et al 2024 as high-level guidance 1 contextual use 2 interaction-elicited emotional experience 3 usability and 4 technical issues with more detailed coding examined as subdomains
The main questions which the trial aims to answer are as follows
1 If the intervention can modify the maladaptive feature of repetitive negative thinking - the investigators anticipate the link between daily rumination and maladaptive outcomes poorer wellbeing higher depressiveanxious symptoms will be weaker in the intervention groups
2 By examining 1 above to confirm the role played by avoidance in repetitive negative thinking
3 By splitting the intervention condition into two groups one receiving concurrent support from a therapist one not to evaluate if interventions such as these might be enhanced by therapist support
4 To examine if the impact of the intervention on depressive and anxious symptoms might be mediated by changes in beliefs regarding emotions eg the valuation of negative emotions
Researchers will compare across four groups to examine the above effects
1 intervention condition therapist support 2 intervention condition no therapist support 3 Partial intervention daily sampling and emotion valuation questions 4 Control group only daily sampling questions
The trial comprises of a four-arm parallel group randomised-controlled trial RCT Participation lasts approximately 2 months including eligibility screening and random allocation to condition random number generator a four-week intervention period delivered via the mobile application and supplemented with daily assessments post-intervention assessments and 1-month follow-up wherein the app will remain available for self-directed use without daily sampling concluding with follow-up assessments and measurement of any engagement with the application during this period
At the point of 1-month follow-up participants previously allocated to the control groups will receive access to the application without the feature of daily sampling and will be provided with guidance on using the intervention content While a 3-month follow-up assessment of intervention participants is planned the 1-month interval allows for control participants to access intervention content without being subject to extensive waitlist delay Active control groups have been chosen to not artificially inflate comparisons with outcomes in the intervention conditions
Analysis
Analysis of changes in outcomes across pre- post- and follow-up-measures PTQ EBQ PBRS NBRS HADS CAQ and BEAQ across all four conditions will be conducted using mixed-design ANOVA
Additionally for all conditions multilevel models daily observations on level 1 nested in participants on level 2 will be used on daily sampling data to assess the links between avoidance and mood and between rumination and mood and to determine if each of these links is moderated by condition Participants respond to these items once daily in the evening in response an in-app reminder alert the time of the alert can be determined by the participant All daily sampling items have been provided in the Measures section
Mixed-design ANCOVA will be used for the two intervention groups to examine if time spent engaging with the application content acts as a covariate in intervention outcomes PTQ EBQ PBRS NBRS HADS CAQ and BEAQ
Finally ongoing development of the application will be assisted using in-app user-feedback data obtained via CORTO implementation three items with gather a combination of quantitative and qualitative data Lukka et al 2024 This data will be coded deductively using the process outlined by Saldana 2016 and using the four categories identified by Lukka et al 2024 as high-level guidance 1 contextual use 2 interaction-elicited emotional experience 3 usability and 4 technical issues with more detailed coding examined as subdomains
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None