The Impact of Stress Management Interventions on Stress Perception, Coping Strategies, and Residual Symptoms in Depression: a Randomized Controlled Trial Investigating Psychological, Biological, Epigenetic, and Brain Correlates
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- Medical University Innsbruck
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Total Change Scores on the Stress Processing Questionnaire (SVF-ak) among Study Completers
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of this clinical trial is to evaluate the effects of a Resilience and Stress Management Intervention Program (RASMUS) compared with yoga on stress perception, coping strategies, depressive symptoms, anxiety, resilience and quality of life in people diagnosed with major depressive disorder (MDD) in the short and long term.
In addition to psychological factors, biological parameters will be examined to define biomarkers involved in stress response. In the optional neuroimaging part, the effects of the planned interventions on the structure, metabolism and function of the brain will be investigated. The epigenetic part, which is also optional, will examine the effects of the planned interventions on the histone modifications.
Detailed Description
The aim of this clinical trial is to evaluate the effects of a Resilience and Stress Management Intervention Program (RASMUS) compared with yoga on stress perception, coping strategies, depressive symptoms, anxiety, resilience and quality of life in people diagnosed with major depressive disorder (MDD) in the short and long term. In addition to psychological factors, biological parameters will be examined to define biomarkers involved in stress response. In the optional neuroimaging part, the effects of the planned interventions on the structure, metabolism and function of the brain will be investigated. The epigenetic part, which is also optional, will examine the effects of the planned interventions on the histone modifications. A total of 80 participants per study arm are planned for both the MRI and epigenetic studies (20 per gender and per type of intervention). 150 outpatients diagnosed with MDD will be randomly assigned to one of two groups: an experimental group receiving RASMUS training, and a control group receiving body-oriented yoga. Both interventions will take place in a group setting of 10-12 participants once a week for one hour over a period of 10 weeks. RASMUS aims to build, reflect on and strengthen stress management strategies and resilience through mindfulness, self-compassion and self-care. Through body-oriented yoga, participants learn through physical exercises to better control and manage their perception of stress. The planned duration of the clinical trial is 4 years. Individual participation in the study will last approximately 8 months and include 4 study visits. The first visit will take place after enrolment. The second and third visits will take place after the fifth and final intervention. The fourth visit will be six months later.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Confirmed diagnosis of MDD,
- •Outpatient care for at least 3 months,
- •Ongoing psychopharmacological treatment,
- •Age between 18 and 65 years,
- •Knowledge of written and spoken German,
- •MADRS score ≤ 34 (moderate severity of symptoms),
- •Written informed consent.
Exclusion Criteria
- •Other Axis I psychiatric disorder (organic mental disorders, psychoactive substance use \[excl. caffeine and nicotine abuse\], schizophrenia, bipolar disorder, neurotic disorders \[excl. anxiety disorders\], eating disorders, acute suicidality)
- •Severe somatic illnesses,
- •Pregnancy/breastfeeding,
- •Undertaking regular yoga practice (more than once per week) over the past 3 months,
- •Current use of psychotherapy.
- •Further exclusion criteria for the neuroimaging sub-study:
- •History of neurological trauma or trauma to the central nervous system,
- •MRI contraindications (claustrophobia, metallic, electrical, magnetic or mechanically driven implants, tattoos on the head or neck or other clinically relevant contraindications)
- •Positive drug urine test.
Outcomes
Primary Outcomes
Total Change Scores on the Stress Processing Questionnaire (SVF-ak) among Study Completers
Time Frame: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Stress perception and stress processing modes in the sense of state characteristics will be assessed with the Stress Processing Questionnaire (SVF-ak) (Janke \& Erdmann, 1997; Janke et al., 1985; Kühn, 1986). The SVF-ak retrospectively asks about the stress processing methods used during a previous stress phase/period. The short version of this instrument which will be used in this study consists of 42 questions for the assessment of the extent to which the 19 processing strategies of the SVF - supplemented by the subtest helplessness - were used in certain stressful situations. Subjects indicate on a 4-point scale ranging from 0 (in no case) to 3 (for sure/ with certainty), how often the thought formulated in the item "went through their mind in the previous situation".
Total Change Scores on the Perceived Stress Scale (PSS-10) among Study Completers
Time Frame: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
The German version of the Perceived Stress Scale (PSS-10) by Klein et al. (2016) will be used to measure excessive demands and the perception of stress. Subjects indicate on a 5-point Likert scale ranging from null (never) to four (very often) the extent to which situations in their own lives were unpredictable, uncontrollable, and overwhelming in the past month.
Secondary Outcomes
- Total Change Scores on the State-Trait-Anxiety Inventory (STAI) among Study Completers(0 weeks (baseline), week 5 (mid), 10 weeks (post treatment) (post1) and 6-months follow-up (post2))
- Total Change Scores on the WHO Quality of Life - Brief Version (WHOQOL-BREF) among Study Completers(0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2))
- Total Change Scores on the Montgomery-Asberg Depression Rating Scale (MADRS) among Study Completers(0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2))
- Alcohol/ tobacco consumption(0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2))
- Total Change Scores on the Resilience Scale for Adults (RSA) among Study Completers(0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2))
- Total Change Scores on the Beck Depression Inventory-II (BDI-II) among Study Completers(0 weeks (baseline), week 5 (mid), 10 weeks (post treatment) (post1) and 6-months follow-up (post2))