Moving on! A Tailored Treatment in a Primary Care Setting for Individuals With Anxiety Disorders?

Condition(s) studied

Investigational drug(s) / intervention(s)

PHYSBI: a 12-week physical exercise program: An individualized 12-week training program including 3 occasions/week of moderate-high intensity.

Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion.: Through questionnaires, the patients answers questions regarding lifestyle habits and the results are converted into a health profile. A care manager will together with the patient decide appropriate health promoting activities to engage in.

Study summary

The goal of this clinical study is to investigate the effects of two different interventions in patients with anxiety disorder and who seeks help at primary care centers. The participants will choose between two interventions:

1. A 12-week physical exercise program with three training sessions per week, or
2. A modified version of eHealth Lift, a digital development of the Health Lift, an evidence based lifestyle-intervention for health promotion and prevention in primary health care.

The participant will fill in self-assessment scales and questionnaires and also have BMI and blood pressure measured at the start of the study, at 12-weeks after the study start and after 1 year.

The main question the investigators aim to answer is if the interventions are better than treatment as usual for this group of patients regarding:

* symptoms of anxiety and depression
* pain
* sleep
* alcohol habits
* fatigue
* general health
* work ability/sick leave
* physical activity
* perceived quality of life
* BMI and blood pressure
* number of health care contacts
* psychopharmaceuticals and analgesics prescribed
* health literacy

Eligibility

Primary outcome measure(s)

• Symptoms of anxiety - BAI — At study start
  Established psychiatric self-assessment scale Beck Anxiety Inventory (BAI). BAI is organized in 21 items, with scoring from nothing (0 p), slightly (1 p), moderately (2p) and severely (3p) and total ratings range from nothing, minimal/mild (score 0-15), moderately (score 16-25) and severely (score 26-63).
• Symptoms of anxiety - BAI — After 12-weeks intervention
  Established psychiatric self-assessment scale Beck Anxiety Inventory (BAI). BAI is organized in 21 items, with scoring from nothing (0 p), slightly (1 p), moderately (2p) and severely (3p) and total ratings range from nothing, minimal/mild (score 0-15), moderately (score 16-25) and severely (score 26-63).
• Symptoms of anxiety - BAI — After one year follow-up
  Established psychiatric self-assessment scale Beck Anxiety Inventory (BAI). BAI is organized in 21 items, with scoring from nothing (0 p), slightly (1 p), moderately (2p) and severely (3p) and total ratings range from nothing, minimal/mild (score 0-15), moderately (score 16-25) and severely (score 26-63).
• Symptoms of Generalized Anxiety Disorder - GAD-7 — At study start
  An established psychiatric self-assessment scale GAD-7 (Symptoms of Generalized Anxiety Disorder). A 7-item scale where anxiety severity is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety
• Symptoms of Generalized Anxiety Disorder - GAD-7 — After 12-weeks intervention
  An established psychiatric self-assessment scale GAD-7 (Symptoms of Generalized Anxiety Disorder). A 7-item scale where anxiety severity is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety
• Symptoms of Generalized Anxiety Disorder - GAD-7 — After one year follow-up
  An established psychiatric self-assessment scale GAD-7 (Symptoms of Generalized Anxiety Disorder). A 7-item scale where anxiety severity is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety
• Symptoms of anxiety - HAD — At study start
  The established psychiatric self-assessment scale HAD (Hospital Anxiety and Depression Scale Symptoms of anxiety) is a scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Score 0-7 = Normal, 8-10 = Borderline abnormal and 11-21 = Abnormal (case).
• Symptoms of anxiety - HAD — After 12-weeks intervention
  The established psychiatric self-assessment scale HAD (Hospital Anxiety and Depression Scale Symptoms of anxiety) is a scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Score 0-7 = Normal, 8-10 = Borderline abnormal and 11-21 = Abnormal (case).
• Symptoms of anxiety - HAD — After one year follow-up
  The established psychiatric self-assessment scale HAD (Hospital Anxiety and Depression Scale Symptoms of anxiety) is a scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Score 0-7 = Normal, 8-10 = Borderline abnormal and 11-21 = Abnormal (case).
• Symptoms of inner tension - MADRS-S; question 2 — At study start
  The established psychiatric self-assessment scale MADRS-S (Montgomery-Åsberg Depression Rating Scale); question 2, which asks about inner tension (a proxy for anxiety). The question is scaled from 0 to 6, with higher scores reflecting more severe symptoms.
• Symptoms of inner tension - MADRS-S; question 2 — After 12-weeks intervention
  The established psychiatric self-assessment scale MADRS-S (Montgomery-Åsberg Depression Rating Scale); question 2, which asks about inner tension (a proxy for anxiety). The question is scaled from 0 to 6, with higher scores reflecting more severe symptoms.
• Symptoms of inner tension - MADRS-S; question 2 — After one year follow-up
  The established psychiatric self-assessment scale MADRS-S (Montgomery-Åsberg Depression Rating Scale); question 2, which asks about inner tension (a proxy for anxiety). The question is scaled from 0 to 6, with higher scores reflecting more severe symptoms.

Trial sites (1)

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