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NCT Number: NCT03311529

Effectiveness and Underlying Mechanisms of Applied Relaxation as Indicated Preventive Intervention

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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Key information

Age range

18 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Technische Universität Dresden

Dresden, 01187, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Applied Relaxation

Behavioral

10 training sessions (90 min. each) in Applied Relaxation (group format)

Primary outcomes

  1. 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)

  2. 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

  1. secondary outcomes 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)

    other symptom changes (DSM-5 CCSM anxiety, depression, anger, somatic symptoms, sleep disturbance)

  2. secondary outcomes 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)

    other clinical changes from baseline- to post-assessment (e.g. impairment, disability)

  3. secondary outcomes prevention efficacy

    Time frame: 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)

  4. secondary outcomes prevention efficacy

    Time frame: 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)

  5. secondary outcomes prevention efficacy

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

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

Acronym: EASY

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 17, 2017
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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