EASY: Effectiveness and Underlying Mechanisms of Applied Relaxation as Indicated Preventive Intervention
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Applied Relaxation
|
Behavioral: Applied Relaxation
10 training sessions (90 min. each) in Applied Relaxation (group format)
|
| No Intervention: usual care
|
Outcome Measures
Primary Outcome Measures
- primary outcome 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)]
reduction of tension/distress, anxiety and depressive symptoms (DASS-21 tension/stress, anxiety and depression)
- primary outcome prevention efficacy [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)]
rates of incident mental disorders (first incidence or recurrence of sub-threshold or threshold DSM-5-defined mental disorders; DIA-X/CIDI)
Secondary Outcome Measures
- 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)]
other symptom changes (DSM-5 CCSM anxiety, depression, anger, somatic symptoms, sleep disturbance)
- 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)]
other clinical changes from baseline- to post-assessment (e.g. impairment, disability)
- 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)]
changes of tension/distress, anxiety and depressive symptoms (DASS-21 tension/stress, anxiety and depression)
- 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)]
other symptom changes (DSM-5 CCSM anxiety, depression, anger, somatic symptoms, sleep disturbance)
- 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)]
other clinical changes (e.g. number of symptoms/diagnoses, impairment, disability)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Technische Universität Dresden | Dresden | Germany | 01187 |
Sponsors and Collaborators
- Technische Universität Dresden
Investigators
- Principal Investigator: Eva Asselmann, PhD, Technische Universität Dresden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AS 497/1-1