Effectiveness and Underlying Mechanisms of Applied Relaxation as Indicated Preventive Intervention

Not Applicable

Completed

• Conditions: Stress Disorder; Depressive Disorder; Anxiety Disorders
• Interventions: Behavioral: Applied Relaxation

• Registration Number: NCT03311529
• Lead Sponsor: Technische Universität Dresden

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-17
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 277

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Applied Relaxation	Applied Relaxation	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Technische Universität Dresden; 🇩🇪 Dresden, Germany