ClinicalTrials.gg
CompletedNCT03311529EASYUpdated Mar 29, 2021

Effectiveness and Underlying Mechanisms of Applied Relaxation as Indicated Preventive Intervention

An interventional study of Applied Relaxation in Anxiety Disorders, Depressive Disorder and Stress Disorder, sponsored by Technische Universität Dresden. Completed at 1 site in Germany. Open to participants aged 18 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-29.

Sponsored by Technische Universität Dresden · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Sep 2016, registered Mar 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
277
Allocation
Randomized
Ages
18 Years to 54 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 133 studies in Anxiety Disorders with a site in Germany — 27 open to participants now, 30 under way, none of them phase 3. Anxiety Disorders · Germany.

Enrollment
22nd of 99
277 · median 138
Started
2016
with 3 others
No phase
76 of 133
21 open now
Registered
43rd of 133
by date

Among the 133 studies in Anxiety Disorders with a site in Germany, this one is the 22nd largest by enrollment of the 99 interventional ones that give a count, is one of 4 that started in 2016, is one of 76 with no phase, and was the 43rd registered.

Anxiety Disorders

7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

Browse Anxiety Disorders studies →

Open to participants now

27 of the 133 studies in Anxiety Disorders with a site in Germany are open now. Recruiting first, the newest first:

22 more — sign in →

All 27 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 944 Anxiety Disorders studies recruiting now, 417 (44%) set no upper age limit and 460 (49%) stop at 75 or younger; 233 take children under 18; 317 take healthy volunteers.

This study: 18 Years to 54 Years · all sexes · healthy volunteers too.

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02

Study 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.

03

Conditions studied

  • Anxiety Disorders
  • Depressive Disorder
  • Stress Disorder
04

Who can participate

Ages eligible
18 Years to 54 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
277 participants (actual)

Study arms

  • Experimental
    Applied Relaxation

    Behavioral: Applied Relaxation

  • No intervention
    usual care

Interventions

  • BehavioralApplied Relaxation

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

06

What researchers measure

Primary outcomes

  1. primary outcome intervention efficacy

    reduction of tension/distress, anxiety and depressive symptoms (DASS-21 tension/stress, anxiety and depression)

    Time frame: 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)

  2. 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)

    Time frame: 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

  1. secondary outcomes intervention efficacy

    other symptom changes (DSM-5 CCSM anxiety, depression, anger, somatic symptoms, sleep disturbance)

    Time frame: 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)

  2. secondary outcomes intervention efficacy

    other clinical changes from baseline- to post-assessment (e.g. impairment, disability)

    Time frame: 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)

  3. secondary outcomes prevention efficacy

    changes of tension/distress, anxiety and depressive symptoms (DASS-21 tension/stress, anxiety and depression)

    Time frame: 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)

  4. secondary outcomes prevention efficacy

    other symptom changes (DSM-5 CCSM anxiety, depression, anger, somatic symptoms, sleep disturbance)

    Time frame: 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)

  5. secondary outcomes prevention efficacy

    other clinical changes (e.g. number of symptoms/diagnoses, impairment, disability)

    Time frame: 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)

07

Study locations

1 site
  • Technische Universität Dresden
    Dresden, 01187, Germany
08

References and documents

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. PubMed 35930850 ↗
  • 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. PubMed 35285766 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2016 to primary completion in Nov 2019, 38 months.

Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 38 months is above that.

Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2017
First posted
Oct 17, 2017
StartActual
Sep 1, 2016
Primary completionActual
Nov 30, 2019
CompletionActual
Dec 30, 2019
Last update
Mar 29, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03311529
Responsible party
Dr. Eva Asselmann (Study Principal Investigator, Technische Universität Dresden) — Principal investigator
First posted
Oct 17, 2017
Start date
Sep 1, 2016
Primary completion
Nov 30, 2019
Completion
Dec 30, 2019
Last update
Mar 29, 2021

Study contacts

Eva Asselmann, PhD
principal investigator · Technische Universität Dresden

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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