Clinical trial NCT03311529: Effectiveness and Underlying Mechanisms of Applied Relaxation as Indicated Preventive Intervention
Official title: Effectiveness and Underlying Mechanisms of Applied Relaxation as Indicated Preventive Intervention in Subjects at Increased Risk for Mental Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Depressive Disorder
Stress Disorder
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: primary outcome intervention efficacy
timeFrame: 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)
measure: primary outcome prevention efficacy
timeFrame: 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 outcomes:
measure: secondary outcomes intervention efficacy
timeFrame: 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)
measure: secondary outcomes intervention efficacy
timeFrame: 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)
measure: secondary outcomes prevention efficacy
timeFrame: 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)
measure: secondary outcomes prevention efficacy
timeFrame: 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)
measure: secondary outcomes prevention efficacy
timeFrame: 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 outcomes:
Locations:
city: Dresden
country: Germany
facility: Technische Universität Dresden
Study officials:
affiliation: Technische Universität Dresden
name: Eva Asselmann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beesdo-Baum K, Zenker M, Ruckert F, Kische H, Pieper L, Asselmann E. Efficacy of Applied Relaxation as indicated preventive intervention in individuals at increased risk for mental disorders: A randomized controlled trial. Behav Res Ther. 2022 Oct;157:104162. doi: 10.1016/j.brat.2022.104162. Epub 2022 Jul 20.
citation: Kische H, Zenker M, Pieper L, Beesdo-Baum K, Asselmann E. Applied relaxation and cortisol secretion: findings from a randomized controlled indicated prevention trial in adults with stress, anxiety, or depressive symptoms. Stress. 2022 Jan;25(1):122-133. doi: 10.1080/10253890.2022.2045939.