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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Applied Relaxation | Experimental |
| |
| usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Applied Relaxation | Behavioral | 10 training sessions (90 min. each) in Applied Relaxation (group format) |
|
| 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) |
| 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) |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Eva Asselmann, PhD | Technische Universität Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technische Universität Dresden | Dresden | 01187 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40655922 | Derived | 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. | |
| 37289760 |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003866 | Depressive Disorder |
| D040921 | Stress Disorders, Traumatic |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D019964 | Mood Disorders |
| D000068099 | Trauma and Stressor Related Disorders |
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| 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) |
| 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. |
| 35930850 | Derived | 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. |
| 35285766 | Derived | 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. |