NCT03311529: EASY

Effectiveness and Underlying Mechanisms of Applied Relaxation as Indicated Preventive Intervention

Completed NA Last updated 29 March 2021

What this trial tests

NA trial testing Applied Relaxation in Anxiety Disorders in 277 participants. Completed in 30 December 2019.

Timeline

1 September 2016

Primary endpoint
30 November 2019

30 December 2019

Quick facts

Lead sponsor	Technische Universität Dresden
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	277
Start date	1 September 2016
Primary completion	30 November 2019
Estimated completion	30 December 2019
Sites	1 location across Germany

Drugs / interventions tested

• Applied Relaxation

Conditions studied

• Anxiety Disorders — all drugs for Anxiety Disorders →
• Depressive Disorder — all drugs for Depressive Disorder →
• Stress Disorder — all drugs for Stress Disorder →

Sponsor

Technische Universität Dresden — full company profile →

Who can join

Adults 18 to 54, any sex, with Anxiety Disorders or Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 tension/distress, 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 tension/distress, 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 intervention/preventive 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ecological momentary assessment and applied relaxation: Results of a randomized indicated preventive trial in individuals at increased risk for mental disorders.
   Asselmann E, Zenker M, Rückert F, Kische H, et al · · 2023 · cited 3× · PMID 37289760 · DOI 10.1371/journal.pone.0286750
2. Cognitive, behavioral, and affective mechanisms underlying the efficacy of Applied Relaxation in reducing psychopathological symptoms: A randomized controlled trial.
   Asselmann E, Rückert F, Kische H, Zenker M, et al · · 2024 · cited 1× · PMID 40655922 · DOI 10.1016/j.xjmad.2024.100055