AnxietyNCT06881758
High Intensity Training for Patients with Anxiety
A study testing Exercise in people with Anxiety and Depression Anxiety Disorder, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The aim of the current project is to examine the effects of high intensity exercise (by using 1x4 intervals) to reduce symptoms of anxiety in patients in mental health care. The expected benefits for patients are positive health effects, by improving physical fitness and reducing psychological symptom burden. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Depression Anxiety Disorder, Blood Pressure Check (Hypertension Screening)
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNorway
- Study dates
- 15 Apr 2025to 31 Dec 2027
- 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
- Patients with mild/moderate anxiety disorders, aged 18-60 years. Anxiety disorders in accordance with F 41 in ICD-10, including generalised anxiety disorder, agoraphobia/panic disorder, social phobia, post-traumatic stress disorder, hypochondria, and obsessive-compulsive disorder.
- Comorbidity will occur, so the patient may also have depression. However, the main disorder should be anxiety.
Who cannot join
- Somatic diseases that may impede training: cardiovascular disease, severe asthma, severe COPD, cancer, poorly regulated diabetes.
- Schizophrenia or bipolar disease
- Suicidality (prior attempts or ongoing risk of suicide)
- Substance addiction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of the current project is to examine the effects of high intensity exercise (by using 1x4 intervals) to reduce symptoms of anxiety in patients in mental health care. The expected benefits for patients are positive health effects, by improving physical fitness and reducing psychological symptom burden. The patients will have the opportunity to learn to use physical activity as a specific measure to be used in their own lives and be a source of coping. Furthermore, knowledge about physical activity and mental health may be applicable in mental health care as a part of a treatment plan.
Read the detailed description
The study is a randomised controlled trial ("RCT") design with a 1:1 allocation into two groups. The two groups are high intensity exercise (1x4 minutes performed two times per week with a heart rate above 85% of maximal heart rate) and low intensity exercise (45 minutes performed two times per week with a heart rate of approximately 60% of maximal heart rate). The total amount of training sessions for both groups will be eight. The high intensity exercise group will serve as the intervention group, while the low intensity exercise group will serve as an active control group.
The patients will be randomly allocated (randomised) to these groups. An exercise physiologist (holding a master's degree in exercise physiology) will supervise the training sessions. The training sessions will take place in a dedicated room using a treadmill and a heart rate monitor. The training sessions will be individual.
The primary outcome measure will be degree of anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS) and Beck Naxiety Inventory (BAI) prior to the first (pre) and after the last (post) training session is completed. Secondary outcome measures will be compliance, i.e. to what degree the patient is able to sustain the exercise regimen three months after participating in the project, in addition to the patient's blood pressure.
- Being tested
- Exercise
- Keywords
- physical exercise, mental health, high intensity training
- Medical subject headings
- Anxiety Disorders, Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
The investigators will investigate the differences between high and low intensity training
| Study group | Role | What they receive |
|---|---|---|
| High intensity exercise training | Experimental | High intensity exercise training Receives: Behavioral: Exercise |
| Low intensity exercise training | Active comparator | Low intensity exercise training Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Hospital Anxiety and Depression Scale (HADS). This a questionnaire generating a scale ranging from 0 to 42 points. Lower scores mean a better outcome.
Measured: HADS will be performed on the first day the patient attends the study and on the very last day the patient attends.
Secondary outcomes (2)
Systolic and diastolic blood pressure
Blood pressure
Measured: We will measure the blood pressure on the first day the patient attends the study and on the very last day the patient attends.
Beck Depression Inventory
Beck Depression Inventory is a questionnaire for detecting depressive symptoms. This questionnaire range from 0 to 63. Lower scores mean a better outcome.
Measured: Beck Depression Inventory will be performed on the first day the patient attends the study and on the very last day the patient attends.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start15 Apr 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (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 AnxietyStudies 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Responsible party
- Principal investigator, Martin Kragnes Bystad, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881758
- Sponsor's protocol ID
- 714458
- Status last verified
- Jan 2025
- First submitted
- 13 Dec 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to various reasons, including concerns about patient privacy and confidentiality, legal or ethical restrictions, the potential risk of re-identifying participants, and the protection of sensitive data.
Publications
Bystad M, Rydland S, Bugge C, Hogmo S, Brondbo B, Jacobsen R, Garcia-Fernandez L, Rodriguez-Jimenez R, Romero-Ferreiro V, Wynn R. High-intensity training vs. low-intensity training for patients with anxiety: a randomised controlled trial. Trials. 2026 Jan 27;27(1):153. doi: 10.1186/s13063-026-09472-2.
PubMed 41593737
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Training for Patients with Anxiety
- ClinicalTrials.gov ID
- NCT06881758
- Acronym / sponsor ID
- 714458
- Keywords
- physical exercise, mental health, high intensity training
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Mar 2025 (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.
The aim of the current project is to examine the effects of high intensity exercise (by using 1x4 intervals) to reduce symptoms of anxiety in patients in mental health care. The expected benefits for patients are positive health effects, by improving physical fitness and reducing psychological symptom burden. The patients will have the opportunity to learn to use physical activity as a specific measure to be used in their own lives and be a source of coping. Furthermore, knowledge about physical activity and mental health may be applicable in mental health care as a part of a treatment plan.
Detailed description
The study is a randomised controlled trial ("RCT") design with a 1:1 allocation into two groups. The two groups are high intensity exercise (1x4 minutes performed two times per week with a heart rate above 85% of maximal heart rate) and low intensity exercise (45 minutes performed two times per week with a heart rate of approximately 60% of maximal heart rate). The total amount of training sessions for both groups will be eight. The high intensity exercise group will serve as the intervention group, while the low intensity exercise group will serve as an active control group.
The patients will be randomly allocated (randomised) to these groups. An exercise physiologist (holding a master's degree in exercise physiology) will supervise the training sessions. The training sessions will take place in a dedicated room using a treadmill and a heart rate monitor. The training sessions will be individual.
The primary outcome measure will be degree of anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS) and Beck Naxiety Inventory (BAI) prior to the first (pre) and after the last (post) training session is completed. Secondary outcome measures will be compliance, i.e. to what degree the patient is able to sustain the exercise regimen three months after participating in the project, in addition to the patient's blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity exercise training | Experimental | Behavioral: ExerciseHigh intensity exercise training |
| Low intensity exercise training | Active comparator | Behavioral: ExerciseLow intensity exercise training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with mild/moderate anxiety disorders, aged 18-60 years. Anxiety disorders in accordance with F 41 in ICD-10, including generalised anxiety disorder, agoraphobia/panic disorder, social phobia, post-traumatic stress disorder, hypochondria, and obsessive-compulsive disorder.
- Comorbidity will occur, so the patient may also have depression. However, the main disorder should be anxiety.
Key exclusion criteria (4 listed)
- Somatic diseases that may impede training: cardiovascular disease, severe asthma, severe COPD, cancer, poorly regulated diabetes.
- Schizophrenia or bipolar disease
- Suicidality (prior attempts or ongoing risk of suicide)
- Substance addiction
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 |
|---|---|---|
| ExerciseThe investigators will investigate the differences between high and low intensity training | Behavioural | High intensity exercise training, Low intensity exercise training |
Primary outcome
Anxiety
Time frame: HADS will be performed on the first day the patient attends the study and on the very last day the patient attends.
Hospital Anxiety and Depression Scale (HADS). This a questionnaire generating a scale ranging from 0 to 42 points. Lower scores mean a better outcome.
2 secondary outcomes
Systolic and diastolic blood pressure
Time frame: We will measure the blood pressure on the first day the patient attends the study and on the very last day the patient attends.
Beck Depression Inventory
Time frame: Beck Depression Inventory will be performed on the first day the patient attends the study and on the very last day the patient attends.
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 18 Mar 2025.
- Derived from this study: PubMed 41593737Bystad M, Rydland S, Bugge C, Hogmo S, Brondbo B, Jacobsen R, Garcia-Fernandez L, Rodriguez-Jimenez R, Romero-Ferreiro V, Wynn R. High-intensity training vs. low-intensity training for patients with anxiety: a randomised controlled trial. Trials. 2026 Jan 27;27(1):153. doi: 10.1186/s13063-026-09472-2.
- Individual participant dataSharing planned: No. IPD will not be shared due to various reasons, including concerns about patient privacy and confidentiality, legal or ethical restrictions, the potential risk of re-identifying participants, and the protection of sensitive data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Anxiety and Depression Anxiety Disorder, run by University Hospital of North Norway at 1 site in Norway.
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 2 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: enrolling by invitation, as of the sponsor's last update on 18 Mar 2025. 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 Norway. 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?
Anxiety (time frame: HADS will be performed on the first day the patient attends the study and on the very last day the patient attends.). 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 NCT06881758, 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 18 Mar 2025.