Ignite Creation Date:
2024-05-06 @ 12:26 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03752853
Status:
COMPLETED
Last Update Posted:
2020-10-23
First Post:
2018-11-13
Brief Title:
Stress Systems and Psychotherapy in Depression
Sponsor:
Freie Universität Berlin
Organization:
Freie Universität Berlin
Study Overview
Official Title:
Biological Correlates of an Internet-based Psychological Intervention for Depression
Status:
COMPLETED
Status Verified Date:
2020-10
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:
Bio-COPE
Brief Summary:
Dysregulation of the hypothalamus-pituitary-adrenal HPA axis as well as maladaptive activation of the autonomic nervous system ANS are discussed as relevant factors in the development of a major depressive episode and as a correlate of its clinical manifestation Preliminary evidence suggests that the hypercortisolaemic pattern in a subgroup of depressed patients may predict non-responses to psychotherapeutic treatment At the same time it is conceivable that disorder-related alterations in HPA axis and ANS regulation change in response to effective treatment such as cognitive behavioural therapy CBT and that those changes could parallel changes in depressive symptoms Identifying such associations may shed light on biological and psychological mechanisms of action underlying successful treatment
However so far no studies have investigated depressed patients with regard to dysregulation in both stress systems HPA axis and ANS before psychotherapeutic treatment nor have changes in functioning of both systems been inspected in response to treatment Moreover a detailed investigation of depressive symptom trajectories over the course of treatment and its associations with changes in HPA axis and ANS regulation is lacking It can be speculated that specific techniques of the treatment eg typical CBT elements such as behavioural activation or cognitive restructuring might particularly be associated with changes in HPA axis and ANS regulation
The main aims of this project are to investigate
1 whether diurnal salivary cortisol and alpha-amylase as well as hair cortisol concentrations change from pre- to post-intervention in treatment responders compared to non-responders
2 whether diurnal salivary cortisol and alpha-amylase concentrations change from pre- to mid-intervention and from mid- to post-intervention in treatment responders compared to non-responders
3 whether changes in diurnal salivary cortisol alpha-amylase and hair cortisol concentrations are significantly correlated with changes in depressive symptoms
4 whether concentrations of diurnal salivary cortisol and alpha-amylase as well as hair cortisol at pre-treatment predict future treatment response ie on a psychological level
On an exploratory level it will be investigated
5 which elements of a CBT intervention for depression behavioural activation vs cognitive restructuring are associated with changes in diurnal salivary cortisol and alpha-amylase concentrations
It is hypothesised
1 that pre- to post-intervention decreases in diurnal salivary cortisol and alpha-amylase as well as hair cortisol concentrations will be more pronounced in responders compared to non-responders
2 that pre- to mid-intervention and mid- to post-intervention decreases in diurnal salivary cortisol and alpha-amylase will be more pronounced in responders compared to non-responders
3 that changes in depressive symptoms will significantly correlate with changes in diurnal cortisol and diurnal alpha-amylase as well as hair cortisol concentrations
4 that pre-intervention diurnal salivary cortisol and alpha-amylase as well as hair cortisol concentrations will be higher in future non-responders compared to responders
However so far no studies have investigated depressed patients with regard to dysregulation in both stress systems HPA axis and ANS before psychotherapeutic treatment nor have changes in functioning of both systems been inspected in response to treatment Moreover a detailed investigation of depressive symptom trajectories over the course of treatment and its associations with changes in HPA axis and ANS regulation is lacking It can be speculated that specific techniques of the treatment eg typical CBT elements such as behavioural activation or cognitive restructuring might particularly be associated with changes in HPA axis and ANS regulation
The main aims of this project are to investigate
1 whether diurnal salivary cortisol and alpha-amylase as well as hair cortisol concentrations change from pre- to post-intervention in treatment responders compared to non-responders
2 whether diurnal salivary cortisol and alpha-amylase concentrations change from pre- to mid-intervention and from mid- to post-intervention in treatment responders compared to non-responders
3 whether changes in diurnal salivary cortisol alpha-amylase and hair cortisol concentrations are significantly correlated with changes in depressive symptoms
4 whether concentrations of diurnal salivary cortisol and alpha-amylase as well as hair cortisol at pre-treatment predict future treatment response ie on a psychological level
On an exploratory level it will be investigated
5 which elements of a CBT intervention for depression behavioural activation vs cognitive restructuring are associated with changes in diurnal salivary cortisol and alpha-amylase concentrations
It is hypothesised
1 that pre- to post-intervention decreases in diurnal salivary cortisol and alpha-amylase as well as hair cortisol concentrations will be more pronounced in responders compared to non-responders
2 that pre- to mid-intervention and mid- to post-intervention decreases in diurnal salivary cortisol and alpha-amylase will be more pronounced in responders compared to non-responders
3 that changes in depressive symptoms will significantly correlate with changes in diurnal cortisol and diurnal alpha-amylase as well as hair cortisol concentrations
4 that pre-intervention diurnal salivary cortisol and alpha-amylase as well as hair cortisol concentrations will be higher in future non-responders compared to responders
Detailed Description:
Recruitment
Patients will be recruited from an ongoing project providing an internet-based cognitive behavioral intervention for patients suffering from mild to moderate depression
Protocol
In this study a total of N42 patients fulfilling criteria for a current major depressive episode will undergo a 6-week internet-based cognitive behavioural intervention which consists of seven consecutive modules Diurnal salivary and hair cortisol as well as diurnal salivary alpha-amylase will be assessed immediately before and after treatment and at mid-treatment ie after four of seven modules Saliva samples six samples per day will be collected over two consecutive days One hair sample will be obtained at pre- and post-intervention assessments respectively
Patients will be recruited from an ongoing project providing an internet-based cognitive behavioral intervention for patients suffering from mild to moderate depression
Protocol
In this study a total of N42 patients fulfilling criteria for a current major depressive episode will undergo a 6-week internet-based cognitive behavioural intervention which consists of seven consecutive modules Diurnal salivary and hair cortisol as well as diurnal salivary alpha-amylase will be assessed immediately before and after treatment and at mid-treatment ie after four of seven modules Saliva samples six samples per day will be collected over two consecutive days One hair sample will be obtained at pre- and post-intervention assessments respectively
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