DepressionFYPONCT04714528
Physical Exercise for Treatment of Depression and Anxiety - RCT
A study testing Physical Exercise and Relaxation Therapy in people with Depression and Anxiety, run by Region Örebro County at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Physical Exercise and Relaxation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2020to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Score ≥12 on MADRS or score ≥16 on BAI
- Inhabitant i Örebro County, Sweden
- BMI ≥18 kg/m^2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity as Treatment for Depression and Anxiety Towards Affordable Preventive Healthcare - a Randomised Controlled Study (RCT)
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.
- Conditions
- Depression, Anxiety
- Being tested
- Physical Exercise, Relaxation Therapy
- Keywords
- Post Traumatic Stress Disorder, Attention Deficit Hyperactivity Disorder, Exercise, Bipolar disorder, Cognitive functions, Biomarkers, Fatty acids, Cytokines, Neurotrophins, Accelerometer, Microbiota, Metabolomics, Lipidomics
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, Attention Deficit Disorder with Hyperactivity, Motor Activity, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExerciseOther
Physical exercise as described before.
Relaxation TherapyOther
Relaxation therapy as described before.
| Study group | Role | What they receive |
|---|---|---|
| Physical Exercise Group | Active comparator | 45 minutes of aerobic, high intensity group training, three times per week during a 12-week period. Receives: Other: Physical Exercise |
| Relaxation Group | Other | 45 minutes of relaxation therapy once per week for 12 weeks. Receives: Other: Relaxation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change of the score from the baseline to the score at 1 year.
Secondary outcomes (15)
Cognitive function: Trail Making Test Part A&B
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Measured: Comparison of results between baseline and week 12.
Cognitive function: Trail Making Test Part A&B
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Measured: Comparison of results between baseline and year 1.
Cognitive function: Symbol Digit Modalities Test
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Measured: Comparison of results between baseline and week 12.
Cognitive function: Symbol Digit Modalities Test
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Measured: Comparison of results between baseline and year 1.
Cognitive function: Corsi Block-Tapping Test forward
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Measured: Comparison of results between baseline and week 12.
Cognitive function: Corsi Block-Tapping Test forward
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Measured: Comparison of results between baseline and year 1.
Cognitive function: Rey Auditory Verbal Learning Test
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Measured: Comparison of results between baseline and week 12.
Cognitive function: Rey Auditory Verbal Learning Test
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Measured: Comparison of results between baseline and year 1.
Cognitive function: Stroop test
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Measured: Comparison of results between baseline and week 12.
Cognitive function: Stroop test
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Measured: Comparison of results between baseline and year 1.
Clinical Global Impression (CGI) severity scale
Clinician's impression of total severity of the mental illness. Scale between 0 and 7, higher point indicates worse outcome.
Measured: Up to 1 year from baseline.
Posttraumatic Stress Disorder Checklist (PCL-5)
Measures symptoms in posttraumatic stress disorder. Total points 0-80, higher point indicates worse outcome.
Measured: Up to 1 year from baseline.
Adult ADHD Self-Report Scale (ASRS)
Measures symptoms in attention deficiency and hyperactivity disorder (ADHD). Minimum 0 point to maximum 72 points. Higher point indicates worse outcome.
Measured: Up to 1 year from baseline.
Perceived Stress Scale (PSS-14)
Measures perceived stress. Minimum 0 point to maximum 56 points. Higher point indicates worse outcome.
Measured: Up to 1 year from baseline.
EuroQol-Health-Related Quality of Life (EQ-5D-5L)
Assesses the current overall health related to wellbeing and function experienced by the patient.
The questionnaire consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
The EQ visual analogue scale (EQ VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine' between 0 and 100. The higher point indicates better outcome.
Measured: Up to 1 year from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Oct 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden, Uppsala University, Karolinska Institutet
- Responsible party
- Principal investigator, Yvonne Freund-Levi, Region Örebro County
- Investigators
- Yvonne Freund-Levi, MD, PhD, Principal investigator, Region Örebro County/Örebro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714528
- Sponsor's protocol ID
- 273723
- Acronym
- FYPO
- Status last verified
- Apr 2024
- First submitted
- 6 Nov 2020
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31681117
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity as Treatment for Depression and Anxiety Towards Affordable Preventive Healthcare - a Randomised Controlled Study (RCT)
- ClinicalTrials.gov ID
- NCT04714528
- Acronym / sponsor ID
- FYPO / 273723
- Conditions
- Depression, Anxiety
- Keywords
- Post Traumatic Stress Disorder, Attention Deficit Hyperactivity Disorder, Exercise, Bipolar disorder, Cognitive functions, Biomarkers, Fatty acids, Cytokines
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Örebro University, Sweden, Uppsala University, Karolinska Institutet
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Exercise Group | Active comparator | Other: Physical Exercise45 minutes of aerobic, high intensity group training, three times per week during a 12-week period. |
| Relaxation Group | Other | Other: Relaxation Therapy45 minutes of relaxation therapy once per week for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Score ≥12 on MADRS or score ≥16 on BAI
- Inhabitant i Örebro County, Sweden
- BMI ≥18 kg/m^2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ExercisePhysical exercise as described before. | Other | Physical Exercise Group |
| Relaxation TherapyRelaxation therapy as described before. | Other | Relaxation Group |
Primary outcome
Symptom improvement in depression
Time frame: Change of the score from the baseline to the score at 12 weeks.
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.
Symptom improvement in depression
Time frame: Change of the score from the baseline to the score at 1 year.
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.
Symptom improvement in anxiety
Time frame: Change of the score from the baseline to the score at 12 weeks.
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.
Symptom improvement in anxiety
Time frame: Change of the score from the baseline to the score at 1 year.
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.
Subjective symptom improvement in depression
Time frame: Change of the score from the baseline to the score at 12 weeks.
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.
Subjective symptom improvement in depression
Time frame: Change of the score from the baseline to the score at 1 year.
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.
15 secondary outcomes
Cognitive function: Trail Making Test Part A&B
Time frame: Comparison of results between baseline and week 12.
Cognitive function: Trail Making Test Part A&B
Time frame: Comparison of results between baseline and year 1.
Cognitive function: Symbol Digit Modalities Test
Time frame: Comparison of results between baseline and week 12.
Cognitive function: Symbol Digit Modalities Test
Time frame: Comparison of results between baseline and year 1.
Cognitive function: Corsi Block-Tapping Test forward
Time frame: Comparison of results between baseline and week 12.
Cognitive function: Corsi Block-Tapping Test forward
Time frame: Comparison of results between baseline and year 1.
Cognitive function: Rey Auditory Verbal Learning Test
Time frame: Comparison of results between baseline and week 12.
Cognitive function: Rey Auditory Verbal Learning Test
Time frame: Comparison of results between baseline and year 1.
Cognitive function: Stroop test
Time frame: Comparison of results between baseline and week 12.
Cognitive function: Stroop test
Time frame: Comparison of results between baseline and year 1.
Clinical Global Impression (CGI) severity scale
Time frame: Up to 1 year from baseline.
Posttraumatic Stress Disorder Checklist (PCL-5)
Time frame: Up to 1 year from baseline.
Adult ADHD Self-Report Scale (ASRS)
Time frame: Up to 1 year from baseline.
Perceived Stress Scale (PSS-14)
Time frame: Up to 1 year from baseline.
EuroQol-Health-Related Quality of Life (EQ-5D-5L)
Time frame: Up to 1 year from baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Background: PubMed 31681117Bjorngrim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Freund-Levi, MD, PhD principal investigator
Region Örebro County/Örebro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise and Relaxation Therapy in people with Depression and Anxiety, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom improvement in depression (time frame: Change of the score from the baseline to the score at 12 weeks.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04714528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.