AnxietyNCT07864324
High-Intensity Interval Training and Mental Health in Psychiatric Inpatients: A Pilot Study
A study testing High-Intensity Interval Training (1 × 4) in people with Anxiety and Depression, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The goal of this pilot clinical trial is to investigate the feasibility of conducting a high-intensity interval training intervention among adult inpatients in a psychiatric care setting and to explore changes in mental health symptoms. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anxiety, Depression, Mental Health
- What is being tested?
- High-Intensity Interval Training (1 × 4)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- 15 Jan 2025to 1 Mar 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- Currently admitted to the Medication-Free Treatment Unit, Mental Health and Substance Abuse Clinic
- At least one previous psychiatric inpatient admission
Who cannot join
- Somatic conditions incompatible with high-intensity exercise, including cardiovascular disease, musculoskeletal conditions, or pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can High-Intensity Exercise Affect Mental Health in Patients Receiving Psychiatric Care? A Clinical Pilot Study
The goal of this pilot clinical trial is to investigate the feasibility of conducting a high-intensity interval training intervention among adult inpatients in a psychiatric care setting and to explore changes in mental health symptoms.
Participants are randomized to either high-intensity interval training or treatment as usual. Participants in the intervention group complete a 1 × 4-minute high-intensity interval training program on a treadmill three times per week for two weeks. Participants in the control group receive treatment as usual.
Anxiety and depression symptoms and general mental health are assessed before and after the intervention period. Feasibility is assessed by recruitment rate and participant dropout.
- Conditions
- Anxiety, Depression, Mental Health, Psychiatric Inpatients
- Being tested
- High-Intensity Interval Training (1 × 4)
- Medical subject headings
- Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval Training (1 × 4)Behavioural
Participants complete high-intensity interval training on a treadmill three times per week for two weeks, for a total of six sessions. Each session consists of a 10-minute warm-up, followed by one 4-minute high-intensity interval at 85-95% of maximum heart rate, and a 5-minute cool-down, for a total duration of 19 minutes. Heart rate is monitored continuously using a chest strap and heart rate monitor. The training sessions are supervised by an exercise physiologist.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Training | Experimental | Participants receive high-intensity interval training (1 × 4) on a treadmill three times per week for two weeks, for a total of six sessions. Each session consists of a 10-minute warm-up, followed by one 4-minute high-intensity interval at 85-95% of maximum heart rate, and a 5-minute cool-down. Receives: Behavioral: High-Intensity Interval Training (1 × 4) |
| Treatment as Usual | Active comparator | Participants assigned to this group receive treatment as usual (TAU) and continue with the usual activities and procedures provided during their psychiatric inpatient stay. No additional exercise intervention is provided as part of the study. Receives: Behavioral: High-Intensity Interval Training (1 × 4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety and Depression Symptom
Anxiety and depression symptoms are assessed using the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items divided into two 7-item subscales: HADS-A for anxiety and HADS-D for depression.
Measured: Baseline and immediately after the two-week intervention period.
Secondary outcomes (3)
Feasibility: Recruitment Rate
Feasibility of conducting a high-intensity interval training study among psychiatric inpatients will be assessed by the recruitment rate. The number of participants recruited to the study will be recorded in relation to the planned sample size of 10 participants.
Measured: Throughout the study recruitment period
Feasibility: Participant Dropout
Feasibility of conducting a high-intensity interval training study among psychiatric inpatients will be assessed by participant dropout. The number and proportion of enrolled participants who discontinue the study before completing the study procedures will be recorded.
Measured: From enrollment through completion of the two-week study period
Change in General Mental Health
General mental health is assessed using the 12-item General Health Questionnaire (GHQ-12), assessing stress and subjective well-being
Measured: Baseline and immediately after the two-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start15 Jan 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864324
- Sponsor's protocol ID
- UNN-HIIT-PILOT-01
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to the small sample size and the potentially sensitive nature of the data collected from psychiatric inpatients, which may increase the risk of participant identification.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can High-Intensity Exercise Affect Mental Health in Patients Receiving Psychiatric Care? A Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT07864324
- Acronym / sponsor ID
- UNN-HIIT-PILOT-01
- Conditions
- Anxiety, Depression, Mental Health, Psychiatric Inpatients
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 7 Oct 2026 (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 goal of this pilot clinical trial is to investigate the feasibility of conducting a high-intensity interval training intervention among adult inpatients in a psychiatric care setting and to explore changes in mental health symptoms.
Participants are randomized to either high-intensity interval training or treatment as usual. Participants in the intervention group complete a 1 × 4-minute high-intensity interval training program on a treadmill three times per week for two weeks. Participants in the control group receive treatment as usual.
Anxiety and depression symptoms and general mental health are assessed before and after the intervention period. Feasibility is assessed by recruitment rate and participant dropout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training | Experimental | Behavioral: High-Intensity Interval Training (1 × 4)Participants receive high-intensity interval training (1 × 4) on a treadmill three times per week for two weeks, for a total of six sessions. Each session consists of a 10-minute warm-up, followed by one 4-minute high-intensity interval at 85-95% of maximum heart rate, and a 5-minute cool-down. |
| Treatment as Usual | Active comparator | Behavioral: High-Intensity Interval Training (1 × 4)Participants assigned to this group receive treatment as usual (TAU) and continue with the usual activities and procedures provided during their psychiatric inpatient stay. No additional exercise intervention is provided as part of the study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60 years
- Currently admitted to the Medication-Free Treatment Unit, Mental Health and Substance Abuse Clinic
- At least one previous psychiatric inpatient admission
Key exclusion criteria (1 listed)
- Somatic conditions incompatible with high-intensity exercise, including cardiovascular disease, musculoskeletal conditions, or pulmonary disease
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 |
|---|---|---|
| High-Intensity Interval Training (1 × 4)Participants complete high-intensity interval training on a treadmill three times per week for two weeks, for a total of six sessions. Each session consists of a 10-minute warm-up, followed by one 4-minute high-intensity interval at 85-95% of maximum heart rate, and a 5-minute cool-down, for a total duration of 19 minutes. Heart rate is monitored continuously using a chest strap and heart rate monitor. The training sessions are supervised by an exercise physiologist. | Behavioural | High-Intensity Interval Training, Treatment as Usual |
Primary outcome
Change in Anxiety and Depression Symptom
Time frame: Baseline and immediately after the two-week intervention period.
Anxiety and depression symptoms are assessed using the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items divided into two 7-item subscales: HADS-A for anxiety and HADS-D for depression.
3 secondary outcomes
Feasibility: Recruitment Rate
Time frame: Throughout the study recruitment period
Feasibility: Participant Dropout
Time frame: From enrollment through completion of the two-week study period
Change in General Mental Health
Time frame: Baseline and immediately after the two-week intervention period.
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 7 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to the small sample size and the potentially sensitive nature of the data collected from psychiatric inpatients, which may increase the risk of participant identification.
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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.
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 High-Intensity Interval Training (1 × 4) in people with Anxiety and Depression, 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 3 inclusion and 1 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 7 Oct 2026. 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?
Change in Anxiety and Depression Symptom (time frame: Baseline and immediately after the two-week intervention period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.