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
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
Browse Anxiety Disorders studies →27 of the 133 studies in Anxiety Disorders with a site in Germany are open now. Recruiting first, the newest first:
Goethe University · Sites in Germany
Ages 18–65
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) · Sites in Germany
Ages 18–99 · Women only
Dr. Nils B. Kroemer · Sites in Germany
Ages 18–40 · Healthy volunteers
Ruhr University of Bochum · Sites in Germany
Ages 18–65
Vera Guttenthaler · Sites in Germany
Ages 18+
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 →
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.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
133 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 9 · Phase 3 10 · Phase 4 3
First in 2001; this study’s year is marked. 4 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 277 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Median enrollment 138 across the 99 interventional studies, 629 across the 33 observational. Of the 89 that completed or were terminated, 5 (6%) have results posted.
This tab as a report to print or save as PDF → With an account.
19 of 133 have an industry lead sponsor. The 10 most frequent:
Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.
Technische Universität Dresden has 3 studies filed under Anxiety Disorders — fewer than ten, so there is no comparison to draw.
11 of the studies in Anxiety Disorders with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07568093Hannover Medical SchoolPARO-agitation-study | 2026-12 |
| NCT07270445Vera GuttenthalerEffect of Virtual Reality Use on Preoperative Anxiety | 2026-12-14 |
| NCT07432945Ruhr University of BochumIn Vivo Exposure vs. Videochat-Based Vicarious Exposure | 2026-12-31 |
| NCT07110896dsm-firmenich Switzerland AGStudy Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults | 2027-02 |
| NCT07065240Seaport TherapeuticsA Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study) | 2027-03 |
Add all 11 to your calendar (.ics) → With an account.
Among the 133 studies in Anxiety Disorders with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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
Behavioral: Applied Relaxation
10 training sessions (90 min. each) in Applied Relaxation (group format)
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)
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 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)
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)
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)
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)
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)
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.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Technische Universität Dresden →