Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-13
Brief Title:
Combining Treatment Components in Transdiagnostic Therapy for Anxiety and Depression
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Combining Treatment Components in Transdiagnostic Therapy for Anxiety and Depression A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study is a randomized controlled trial that will evaluate the effect of combining two treatment components ie cognitive restructuring and detached mindfulness drawn from cognitive behavioral therapies CBTs that are often combined in clinical practice However knowledge about the effect of combining these treatment components is lacking Therefore this study aims to explore single combined and sequencing effects of these two treatment components in patients with depression andor anxiety disorders Furthermore the study aims to explore possible demographic and clinical moderators of the effects to address the question of what works for whom
Detailed Description:
A relatively large proportion of psychotherapists endorse practicing eclectic or integrative therapy drawing from different schools of therapy Norcross Alexander 2019 This tendency towards integrative therapy has been expressed by former president of the Association of Cognitive and Behavioral Therapies J B Persons who writes We clinicians rarely proceed through a single protocol from beginning to end Instead we use what might be called a mix-and-match strategy in which we select interventions or modules from one or even two or more protocols that we believe will be helpful to the patient Persons 2005 p 107 Indeed there has been a growing research and clinical interest in personalized therapy where treatment components from different therapies are combined with the aim of targeting the symptomatology and theorized maintenance processes of the individual patient Cohen et al 2021 DeRubeis et al 2014 Fisher et al 2019 Fisher Boswell 2016 Hayes et al 2022 Huibers et al 2021 Sauer-Zavala et al 2022 In addition to this an increasing number of therapies are designed by combining components from different treatment models eg modular and process-based therapies Barlow et al 2018 Hofmann Hayes 2019 Hofmann et al 2021 As a result patients are likely to be the recipients of several different techniques or strategies based on different theoretical models emphasizing different change principles However the extent to which compatibility exists between different treatment components remains an underexplored scientific question The present study aims to fill this gap
Combining cognitive behavioral therapies
Cognitive behavioral therapies CBTs are among the most well-researched psychological treatments for anxiety and depressive disorders Cuijpers 2017 Cuijpers et al 2014 While CBT is often viewed as one of the major schools of psychotherapy specific CBTs differ in their rationale and understanding of the key maintaining processes in psychopathology Hayes 2004 A core tenet of traditional CBT also known as second-wave CBT is that psychopathology is maintained by maladaptive or irrational thoughts Beck 1976 Thus a commonly used therapeutic component derived from second-wave CBT is cognitive restructuring where the patient is taught to think more realistically about emotion-evoking situations Beck et al 1979 Clark Beck 2010 Thus cognitive restructuring can be said to target the content of thoughts
In contrast newer contemporary or so-called third-wave CBTs such as metacognitive therapy MCT acceptance and commitment therapy ACT and mindfulness-based cognitive therapy MBCT target thought processes Hayes 2004 A commonly used therapeutic component across third-wave CBTs involves teaching the patient to meet their experiences with mindfulness and acceptance rather than attempting to change their form termed detached mindfulness in MCT defusion in ACT and decentering in MCT Hayes et al 2012 Segal et al 2002 Wells 2009 Thus it can be argued that second- and third-wave CBTs reflect very different ways of approaching ones inner life
Despite the differences between second- and third-wave CBTs treatment components from each wave are often combined One example of this is the widely employed Unified Protocol UP which is a transdiagnostic modular cognitive-behavioral treatment for emotional disorders eg anxiety and depression Barlow et al 2018 In UP patients are asked to engage in cognitive restructuring within the treatment module of cognitive flexibility in one module and to practice detached mindfulness within the treatment module of mindful emotion awareness in another Barlow et al 2018 Several studies have documented that UP is an effective treatment for anxiety and depression Longley Gleiser 2023 However since the treatment modules in UP are rooted in different therapeutic traditions with different rationales an intriguing question remains whether the treatment modules are in fact compatible If not then it is possible that UP is effective not because but rather despite the combination of the treatment modules OToole et al 2024
Compatibility of components
Regarding the combination of mindful emotion awareness and cognitive flexibility it is theoretically plausible that these modules might be incompatible since the technique of noticing and accepting ones thoughtsemotions in the module mindful emotion awareness could be argued to be in opposition to the technique of actively changing ones thoughts in the module cognitive flexibility This notion is supported by a small study N12 by Gkika and Wells 2015 which investigated the effect of cognitive restructuring and detached mindfulness in an anxiety-provoking situation in patients with elevated symptoms of social anxiety They found that each technique alone reduced symptoms of social anxiety However when combined a sequencing effect emerged where detached mindfulness followed by cognitive restructuring but not the reverse led to increased anxiety Gkika Wells 2015 Borlimi et al 2019 similarly demonstrated a sequencing effect They asked non-clinical participants N35 to recall an unpleasant experience and apply either cognitive restructuring or an acceptance technique Acceptance reduced sympathetic reactivity ie galvanic skin response more than cognitive restructuring and importantly the effect was significantly larger when acceptance followed cognitive restructuring than vice versa Borlimi et al 2019
The studies by Gkika and Wells 2015 and Borlimi et al 2019 are both laboratory experimental studies The question thus remains whether and how their findings can be generalized to a clinical context with longer duration of each treatment component Only one larger intervention study exploring combinatory and sequencing effects exists In this study Brose et al 2023 investigated the effect of internet-based cognitive restructuring and behavioral activation on symptoms of depression delivered over 6 weeks Individuals with mild to moderate depressive symptoms N2304 were randomized to one of two treatment arms one receiving behavioral activation followed by cognitive restructuring the other vice versa The groups had similar dropout rates and showed similar improvements over time indicating no incongruency between those two components Besides differences in size and setting experimental vs actual treatment the study by Brose et al 2023 also differs from the other clinical studies by testing a cognitive component against a behavioral component instead of comparing different cognitive components eg cognitive restructuring and detached mindfulness against each other In this case the rationales may be more consistent with each other
Taken together the research findings described above coupled with results from the few other available studies of combinatory effects Dibbets et al 2012 Woelk et al 2022 testify that combining otherwise effective stand-alone treatment components 1 does not necessarily yield an additive effect 2 may even sometimes detract from a positive outcome and 3 that the combined effect may depend on the order of the components Thus to be able to combine different treatment components for anxiety and depression effectively there is a need for intervention studies examining single combined and sequencing effects for treatment components from different therapies that are often combined Currently such research is sparse thereby motivating the present study Moreover understanding for whom these effects are likely to occur is important for the appropriate adaptations of therapeutic interventions to fit the needs of the individual patients ie personalized therapy Cohen et al 2021
Aims and hypotheses
The primary aim of the present study is to explore the effect of combining treatment components drawn from different CBTs Thus we will explore single combined and sequencing effects of two treatment modules ie mindful emotion awareness and cognitive flexibility These modules are routinely delivered together in UP for patients with anxiety disorders or MDD It is hypothesized that both mindful emotion awareness and cognitive flexibility when delivered individually will be effective in reducing symptoms of anxiety and depression The study will take an exploratory stance regarding combined and sequencing effects and will explore if combined effects are best understood as non-additive additive synergistic or antagonistic cf OToole et al 2024
A secondary aim of the study is to explore possible demographic and clinical moderators of the effects eg primary diagnosis baseline cognitive function and symptomatology to address the question of what works for whom
Combining cognitive behavioral therapies
Cognitive behavioral therapies CBTs are among the most well-researched psychological treatments for anxiety and depressive disorders Cuijpers 2017 Cuijpers et al 2014 While CBT is often viewed as one of the major schools of psychotherapy specific CBTs differ in their rationale and understanding of the key maintaining processes in psychopathology Hayes 2004 A core tenet of traditional CBT also known as second-wave CBT is that psychopathology is maintained by maladaptive or irrational thoughts Beck 1976 Thus a commonly used therapeutic component derived from second-wave CBT is cognitive restructuring where the patient is taught to think more realistically about emotion-evoking situations Beck et al 1979 Clark Beck 2010 Thus cognitive restructuring can be said to target the content of thoughts
In contrast newer contemporary or so-called third-wave CBTs such as metacognitive therapy MCT acceptance and commitment therapy ACT and mindfulness-based cognitive therapy MBCT target thought processes Hayes 2004 A commonly used therapeutic component across third-wave CBTs involves teaching the patient to meet their experiences with mindfulness and acceptance rather than attempting to change their form termed detached mindfulness in MCT defusion in ACT and decentering in MCT Hayes et al 2012 Segal et al 2002 Wells 2009 Thus it can be argued that second- and third-wave CBTs reflect very different ways of approaching ones inner life
Despite the differences between second- and third-wave CBTs treatment components from each wave are often combined One example of this is the widely employed Unified Protocol UP which is a transdiagnostic modular cognitive-behavioral treatment for emotional disorders eg anxiety and depression Barlow et al 2018 In UP patients are asked to engage in cognitive restructuring within the treatment module of cognitive flexibility in one module and to practice detached mindfulness within the treatment module of mindful emotion awareness in another Barlow et al 2018 Several studies have documented that UP is an effective treatment for anxiety and depression Longley Gleiser 2023 However since the treatment modules in UP are rooted in different therapeutic traditions with different rationales an intriguing question remains whether the treatment modules are in fact compatible If not then it is possible that UP is effective not because but rather despite the combination of the treatment modules OToole et al 2024
Compatibility of components
Regarding the combination of mindful emotion awareness and cognitive flexibility it is theoretically plausible that these modules might be incompatible since the technique of noticing and accepting ones thoughtsemotions in the module mindful emotion awareness could be argued to be in opposition to the technique of actively changing ones thoughts in the module cognitive flexibility This notion is supported by a small study N12 by Gkika and Wells 2015 which investigated the effect of cognitive restructuring and detached mindfulness in an anxiety-provoking situation in patients with elevated symptoms of social anxiety They found that each technique alone reduced symptoms of social anxiety However when combined a sequencing effect emerged where detached mindfulness followed by cognitive restructuring but not the reverse led to increased anxiety Gkika Wells 2015 Borlimi et al 2019 similarly demonstrated a sequencing effect They asked non-clinical participants N35 to recall an unpleasant experience and apply either cognitive restructuring or an acceptance technique Acceptance reduced sympathetic reactivity ie galvanic skin response more than cognitive restructuring and importantly the effect was significantly larger when acceptance followed cognitive restructuring than vice versa Borlimi et al 2019
The studies by Gkika and Wells 2015 and Borlimi et al 2019 are both laboratory experimental studies The question thus remains whether and how their findings can be generalized to a clinical context with longer duration of each treatment component Only one larger intervention study exploring combinatory and sequencing effects exists In this study Brose et al 2023 investigated the effect of internet-based cognitive restructuring and behavioral activation on symptoms of depression delivered over 6 weeks Individuals with mild to moderate depressive symptoms N2304 were randomized to one of two treatment arms one receiving behavioral activation followed by cognitive restructuring the other vice versa The groups had similar dropout rates and showed similar improvements over time indicating no incongruency between those two components Besides differences in size and setting experimental vs actual treatment the study by Brose et al 2023 also differs from the other clinical studies by testing a cognitive component against a behavioral component instead of comparing different cognitive components eg cognitive restructuring and detached mindfulness against each other In this case the rationales may be more consistent with each other
Taken together the research findings described above coupled with results from the few other available studies of combinatory effects Dibbets et al 2012 Woelk et al 2022 testify that combining otherwise effective stand-alone treatment components 1 does not necessarily yield an additive effect 2 may even sometimes detract from a positive outcome and 3 that the combined effect may depend on the order of the components Thus to be able to combine different treatment components for anxiety and depression effectively there is a need for intervention studies examining single combined and sequencing effects for treatment components from different therapies that are often combined Currently such research is sparse thereby motivating the present study Moreover understanding for whom these effects are likely to occur is important for the appropriate adaptations of therapeutic interventions to fit the needs of the individual patients ie personalized therapy Cohen et al 2021
Aims and hypotheses
The primary aim of the present study is to explore the effect of combining treatment components drawn from different CBTs Thus we will explore single combined and sequencing effects of two treatment modules ie mindful emotion awareness and cognitive flexibility These modules are routinely delivered together in UP for patients with anxiety disorders or MDD It is hypothesized that both mindful emotion awareness and cognitive flexibility when delivered individually will be effective in reducing symptoms of anxiety and depression The study will take an exploratory stance regarding combined and sequencing effects and will explore if combined effects are best understood as non-additive additive synergistic or antagonistic cf OToole et al 2024
A secondary aim of the study is to explore possible demographic and clinical moderators of the effects eg primary diagnosis baseline cognitive function and symptomatology to address the question of what works for whom
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None