Clinical trial NCT04714528: Physical Exercise for Treatment of Depression and Anxiety - RCT
Official title: Physical Activity as Treatment for Depression and Anxiety Towards Affordable Preventive Healthcare - a Randomised Controlled Study (RCT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Keywords: Post Traumatic Stress Disorder
Attention Deficit Hyperactivity Disorder
Exercise
Bipolar disorder
Cognitive functions
Biomarkers
Fatty acids
Cytokines
Neurotrophins
Accelerometer
Microbiota
Metabolomics
Lipidomics
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Örebro University, Sweden
name: Uppsala University
name: Karolinska Institutet
First posted: 2021-01-19
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a 12 week randomly controlled open trial 102 participants with symptoms of depression and/or anxiety will be exposed to either aerobic high intensity training (HIT) or relaxation therapy. Cognitive functions, biomarkers, psychiatric symptom scales and physical status will be collected at baseline, after 12 weeks and after a year. Depression and anxiety will be measured twice during the intervention period.


Eligibility criteria: Inclusion Criteria:

* Score ≥12 on MADRS or score ≥16 on BAI
* Inhabitant i Örebro County, Sweden
* BMI ≥18 kg/m\^2

Exclusion Criteria:

* Diagnosis of chronic psychotic disease or ongoing psychotic episode.
* Ongoing manic state of bipolar disorder
* Severe somatic disease or condition where high intensity exercise is contraindicated
* Difficulty with reading, hearing or understanding the Swedish language

Primary outcomes:
measure: Symptom improvement in depression
timeFrame: Change of the score from the baseline to the score at 12 weeks.
measure: Symptom improvement in depression
timeFrame: Change of the score from the baseline to the score at 1 year.
measure: Symptom improvement in anxiety
timeFrame: Change of the score from the baseline to the score at 12 weeks.
measure: Symptom improvement in anxiety
timeFrame: Change of the score from the baseline to the score at 1 year.
measure: Subjective symptom improvement in depression
timeFrame: Change of the score from the baseline to the score at 12 weeks.
measure: Subjective symptom improvement in depression
timeFrame: Change of the score from the baseline to the score at 1 year.
Secondary outcomes:
measure: Cognitive function: Trail Making Test Part A&B
timeFrame: Comparison of results between baseline and week 12.
measure: Cognitive function: Trail Making Test Part A&B
timeFrame: Comparison of results between baseline and year 1.
measure: Cognitive function: Symbol Digit Modalities Test
timeFrame: Comparison of results between baseline and week 12.
measure: Cognitive function: Symbol Digit Modalities Test
timeFrame: Comparison of results between baseline and year 1.
measure: Cognitive function: Corsi Block-Tapping Test forward
timeFrame: Comparison of results between baseline and week 12.
measure: Cognitive function: Corsi Block-Tapping Test forward
timeFrame: Comparison of results between baseline and year 1.
measure: Cognitive function: Rey Auditory Verbal Learning Test
timeFrame: Comparison of results between baseline and week 12.
measure: Cognitive function: Rey Auditory Verbal Learning Test
timeFrame: Comparison of results between baseline and year 1.
measure: Cognitive function: Stroop test
timeFrame: Comparison of results between baseline and week 12.
measure: Cognitive function: Stroop test
timeFrame: Comparison of results between baseline and year 1.
measure: Clinical Global Impression (CGI) severity scale
timeFrame: Up to 1 year from baseline.
measure: Posttraumatic Stress Disorder Checklist (PCL-5)
timeFrame: Up to 1 year from baseline.
measure: Adult ADHD Self-Report Scale (ASRS)
timeFrame: Up to 1 year from baseline.
measure: Perceived Stress Scale (PSS-14)
timeFrame: Up to 1 year from baseline.
measure: EuroQol-Health-Related Quality of Life (EQ-5D-5L)
timeFrame: Up to 1 year from baseline.
Other outcomes:
measure: Changes in gut microbiomes
timeFrame: Up to 1 year from baseline.
measure: Investigation of inflammatory biomarkers profile
timeFrame: Up to 1 year from baseline.
measure: Investigation of fatty acid profiles
timeFrame: Up to 1 year from baseline.
Locations:
city: Örebro
country: Sweden
facility: Department of Psychiatry, University hospital Örebro
Study officials:
affiliation: Region Örebro County/Örebro University
name: Yvonne Freund-Levi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjorngrim S, van den Hurk W, Betancort M, Machado A, Lindau M. Comparing Traditional and Digitized Cognitive Tests Used in Standard Clinical Evaluation - A Study of the Digital Application Minnemera. Front Psychol. 2019 Oct 18;10:2327. doi: 10.3389/fpsyg.2019.02327. eCollection 2019.