Ignite Creation Date:
2024-05-06 @ 10:38 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03311529
Status:
COMPLETED
Last Update Posted:
2021-03-29
First Post:
2017-03-10
Brief Title:
Effectiveness and Underlying Mechanisms of Applied Relaxation as Indicated Preventive Intervention
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
Effectiveness and Underlying Mechanisms of Applied Relaxation as Indicated Preventive Intervention in Subjects at Increased Risk for Mental Disorders
Status:
COMPLETED
Status Verified Date:
2021-03
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:
EASY
Brief Summary:
As mental disorders constitute a core health care challenge of the 21th century increased research efforts on preventive interventions are indispensable In the field of clinical psychology indicated preventive interventions targeted to those with initial symptomatology appear particularly promising Applied relaxation AR is a well-established intervention technique proven to effectively reduce tensiondistress anxiety and depressive symptoms in the context of treatment of a wide variety of manifest mental disorders as well as somatic illnesses However it has not been studied so far whether AR as indicated preventive intervention in subjects with initial symptomatology but no full-threshold mental disorder yet is capable to prevent a further symptom escalation This randomized controlled trial in subjects with elevated tensiondistress anxiety or depressive symptomatology aims to investigate whether an AR intervention 10 sessions à 60 min can a effectively reduce present psychopathological symptoms as well as b prevent a further symptom progression to full-threshold DSM-5 mental disorders Putative mediators physiological emotional cognitive and behavioral changes including heart rate and heart rate variability hair and salivary cortisol secretion affectivity self-efficacy internal locus of control and cognitive behavioral coping and moderators sex age symptom severity at baseline and homework adherence during the intervention course of the interventionpreventive efficacy will be additionally studied Predictor and outcome measures will be assessed both conventionally via personal interview questionnaires and physiological measures during the respective main assessment and with ecological momentary assessments EMA applied via smart phone over a 1-week interval following the respective main assessment in everyday life
Detailed Description:
None
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