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Enrolling by Invitation

NCT Number: NCT06881758

High Intensity Training for Patients with Anxiety

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North Norway

Tromsø, 9015, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Exercise

Behavioral

The investigators will investigate the differences between high and low intensity training

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    Blood pressure

  2. 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.

    Beck Depression Inventory is a questionnaire for detecting depressive symptoms. This questionnaire range from 0 to 63. Lower scores mean a better outcome.

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • University of Tromso

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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