Effectiveness and Underlying Mechanisms of Applied Relaxation as Indicated Preventive Intervention

Study Overview
=================
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.

Official Title
-----------------
Effectiveness and Underlying Mechanisms of Applied Relaxation as Indicated Preventive Intervention in Subjects at Increased Risk for Mental Disorders

Conditions
-----------------
Anxiety Disorders, Depressive Disorder, Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Applied Relaxation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Applied Relaxation<br> | Behavioral: Applied Relaxation<br>* 10 training sessions (90 min. each) in Applied Relaxation (group format)<br>|
| No Intervention: usual care<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |