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Clinical Trials/NCT03311529
NCT03311529CompletedNot Applicable

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

Technische Universität Dresden2 sites in 1 country277 target enrollmentStarted: September 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
277
Locations
2
Primary Endpoint
primary outcome intervention efficacy

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 54 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

primary outcome intervention efficacy

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)

reduction of tension/distress, anxiety and depressive symptoms (DASS-21 tension/stress, anxiety and depression)

primary outcome prevention efficacy

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)

rates of incident mental disorders (first incidence or recurrence of sub-threshold or threshold DSM-5-defined mental disorders; DIA-X/CIDI)

Secondary Outcomes

  • 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))
  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Eva Asselmann

Study Principal Investigator

Technische Universität Dresden

Study Sites (2)

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