NCT04714528

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
8mo left

Started Oct 2020

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Oct 2020Dec 2026

Study Start

First participant enrolled

October 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

4.3 years

First QC Date

November 6, 2020

Last Update Submit

April 29, 2024

Conditions

DepressionAnxiety

Keywords

Post Traumatic Stress DisorderAttention Deficit Hyperactivity DisorderExerciseBipolar disorderCognitive functionsBiomarkersFatty acidsCytokinesNeurotrophinsAccelerometerMicrobiotaMetabolomicsLipidomics

Outcome Measures

Primary Outcomes (6)

  • Symptom improvement in depression

    Improvement of symptom severity grade are assessed with Montgomery-Åsberg Depression Rating Scale (MADRS). The minimum and the maximum score is 0 and 60 respectively, and the higher score means a worse outcome.

    Change of the score from the baseline to the score at 12 weeks.

  • Symptom improvement in depression

    Improvement of symptom severity grade are assessed with Montgomery-Åsberg Depression Rating Scale (MADRS). The minimum and the maximum score is 0 and 60 respectively, and the higher score means a worse outcome.

    Change of the score from the baseline to the score at 1 year.

  • Symptom improvement in anxiety

    Improvement of symptom severity grade are assessed with Beck Anxiety Inventory (BAI). The minimum and the maximum score is 0 and 63 respectively, and the higher score means a worse outcome.

    Change of the score from the baseline to the score at 12 weeks.

  • Symptom improvement in anxiety

    Improvement of symptom severity grade are assessed with Beck Anxiety Inventory (BAI). The minimum and the maximum score is 0 and 63 respectively, and the higher score means a worse outcome.

    Change of the score from the baseline to the score at 1 year.

  • Subjective symptom improvement in depression

    Improvement of symptom severity grade are assessed with Montgomery-Åsberg Depression Rating Scale Self-Rating Version (MADRS-S). The minimum and the maximum score is 0 and 60 respectively, and the higher score means a worse outcome.

    Change of the score from the baseline to the score at 12 weeks.

  • Subjective symptom improvement in depression

    Improvement of symptom severity grade are assessed with Montgomery-Åsberg Depression Rating Scale Self-Rating Version (MADRS-S). The minimum and the maximum score is 0 and 60 respectively, and the higher score means a worse outcome.

    Change of the score from the baseline to the score at 1 year.

Secondary Outcomes (15)

  • Cognitive function: Trail Making Test Part A&B

    Comparison of results between baseline and week 12.

  • Cognitive function: Trail Making Test Part A&B

    Comparison of results between baseline and year 1.

  • Cognitive function: Symbol Digit Modalities Test

    Comparison of results between baseline and week 12.

  • Cognitive function: Symbol Digit Modalities Test

    Comparison of results between baseline and year 1.

  • Cognitive function: Corsi Block-Tapping Test forward

    Comparison of results between baseline and week 12.

  • +10 more secondary outcomes

Other Outcomes (3)

  • Changes in gut microbiomes

    Up to 1 year from baseline.

  • Investigation of inflammatory biomarkers profile

    Up to 1 year from baseline.

  • Investigation of fatty acid profiles

    Up to 1 year from baseline.

Study Arms (2)

Physical Exercise Group

ACTIVE COMPARATOR

45 minutes of aerobic, high intensity group training, three times per week during a 12-week period.

Other: Physical Exercise

Relaxation Group

OTHER

45 minutes of relaxation therapy once per week for 12 weeks.

Other: Relaxation Therapy

Interventions

Physical ExerciseOTHER

Physical exercise as described before.

Physical Exercise Group
Relaxation TherapyOTHER

Relaxation therapy as described before.

Relaxation Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, University hospital Örebro

Örebro, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 31681117BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety DisordersStress Disorders, Post-TraumaticAttention Deficit Disorder with HyperactivityMotor ActivityBipolar Disorder

Interventions

ExerciseRelaxation Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Yvonne Freund-Levi, MD, PhD

    Region Örebro County/Örebro University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, M.D., Ph.D

Study Record Dates

First Submitted

November 6, 2020

First Posted

January 19, 2021

Study Start

October 1, 2020

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)