Effectiveness and Underlying Mechanisms of Applied Relaxation as Indicated Preventive Intervention (EASY)

Effectiveness and Underlying Mechanisms of Applied Relaxation as Indicated Preventive Intervention in Subjects at Increased Risk for Mental Disorders

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder; Anxiety Disorders; Stress Disorder
• Intervention / Treatment: Behavioral: Applied Relaxation

• Study Type: Interventional
• Enrollment (Actual): 277
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01187
    • Technische Universität Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 54 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria are as follows: at least mild symptoms of tension/distress, anxiety or depression (DASS-21 score of 8 or higher on tension/stress, of 4 or higher on anxiety, and of 5 or higher on depression)

Exclusion criteria are as follows: (1) a 12-month diagnosis of any mental disorder, (2) lifetime psychotic symptoms, (3) current psychological or psychopharmacological intervention, (4) acute suicidality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: usual care
Experimental: Applied Relaxation	Behavioral: Applied Relaxation; 10 training sessions (90 min. each) in Applied Relaxation (group format)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary outcome intervention efficacy	reduction of tension/distress, anxiety and depressive symptoms (DASS-21 tension/stress, anxiety and depression)	from baseline- (immediately prior to the 10-week intervention) to post-assessment (immediately after completion of the 10-week intervention or a comparable time frame in controls)
primary outcome prevention efficacy	rates of incident mental disorders (first incidence or recurrence of sub-threshold or threshold DSM-5-defined mental disorders; DIA-X/CIDI)	from entry exam (prior to the 10-week intervention) to follow-up-assessment (12 months after completion of the 10-week intervention or a comparable time frame in controls)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
secondary outcomes intervention efficacy	other symptom changes (DSM-5 CCSM anxiety, depression, anger, somatic symptoms, sleep disturbance)	from baseline- (immediately prior to the 10-week intervention) to post-assessment (immediately after completion of the 10-week intervention or a comparable time frame in controls)
secondary outcomes intervention efficacy	other clinical changes from baseline- to post-assessment (e.g. impairment, disability)	from baseline- (immediately prior to the 10-week intervention) to post-assessment (immediately after completion of the 10-week intervention or a comparable time frame in controls)
secondary outcomes prevention efficacy	changes of tension/distress, anxiety and depressive symptoms (DASS-21 tension/stress, anxiety and depression)	from post-assessment (immediately after completion of the 10-week intervention or a comparable time frame in controls) to follow-up-assessment (12 months after completion of the 10-week intervention or a comparable time frame in controls)
secondary outcomes prevention efficacy	other symptom changes (DSM-5 CCSM anxiety, depression, anger, somatic symptoms, sleep disturbance)	from post-assessment (immediately after completion of the 10-week intervention or a comparable time frame in controls) to follow-up-assessment (12 months after completion of the 10-week intervention or a comparable time frame in controls)
secondary outcomes prevention efficacy	other clinical changes (e.g. number of symptoms/diagnoses, impairment, disability)	from post-assessment (immediately after completion of the 10-week intervention or a comparable time frame in controls) to follow-up-assessment (12 months after completion of the 10-week intervention or a comparable time frame in controls)

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Investigators: Principal Investigator: Eva Asselmann, PhD, Technische Universität Dresden

Publications and helpful links

General Publications

• Beesdo-Baum K, Zenker M, Ruckert F, Kische H, Pieper L, Asselmann E. Efficacy of Applied Relaxation as indicated preventive intervention in individuals at increased risk for mental disorders: A randomized controlled trial. Behav Res Ther. 2022 Oct;157:104162. doi: 10.1016/j.brat.2022.104162. Epub 2022 Jul 20.
• Kische H, Zenker M, Pieper L, Beesdo-Baum K, Asselmann E. Applied relaxation and cortisol secretion: findings from a randomized controlled indicated prevention trial in adults with stress, anxiety, or depressive symptoms. Stress. 2022 Jan;25(1):122-133. doi: 10.1080/10253890.2022.2045939.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Depressive Disorder; Disease; Anxiety Disorders
• Other Study ID Numbers: AS 497/1-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No