NCT03311529

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

3.2 years

First QC Date

March 10, 2017

Last Update Submit

March 25, 2021

Conditions

Anxiety DisordersDepressive DisorderStress Disorder

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • secondary outcomes intervention efficacy

    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

    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

    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

    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

    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)

Study Arms (2)

Applied Relaxation

EXPERIMENTAL
Behavioral: Applied Relaxation

usual care

NO INTERVENTION

Interventions

Applied RelaxationBEHAVIORAL

10 training sessions (90 min. each) in Applied Relaxation (group format)

Applied Relaxation

Eligibility Criteria

Age18 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technische Universität Dresden

Dresden, 01187, Germany

Location

Related Publications (4)

  • Asselmann E, Ruckert F, Kische H, Zenker M, Pieper L, Beesdo-Baum K. Cognitive, behavioral, and affective mechanisms underlying the efficacy of Applied Relaxation in reducing psychopathological symptoms: A randomized controlled trial. J Mood Anxiety Disord. 2024 Feb 22;6:100055. doi: 10.1016/j.xjmad.2024.100055. eCollection 2024 Jun.

    PMID: 40655922DERIVED

  • Asselmann E, Zenker M, Ruckert F, Kische H, Pieper L, Beesdo-Baum K. Ecological momentary assessment and applied relaxation: Results of a randomized indicated preventive trial in individuals at increased risk for mental disorders. PLoS One. 2023 Jun 8;18(6):e0286750. doi: 10.1371/journal.pone.0286750. eCollection 2023.

    PMID: 37289760DERIVED

  • 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.

    PMID: 35930850DERIVED

  • 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.

    PMID: 35285766DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepressive DisorderStress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Mental DisordersMood DisordersTrauma and Stressor Related Disorders

Study Officials

  • Eva Asselmann, PhD

    Technische Universität Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

March 10, 2017

First Posted

October 17, 2017

Study Start

September 1, 2016

Primary Completion

November 30, 2019

Study Completion

December 30, 2019

Last Updated

March 29, 2021

Record last verified: 2021-03

Locations

DE(1)