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

NCT06715852 | Recruiting DMC

• 1 other identifier: Dnr 2024-02725-01
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Conditions

Anxiety

Outcome Measures

Primary Outcomes (12)

• Symptoms of anxiety - BAI

  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).

  At study start

• Symptoms of anxiety - BAI

  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).

  After 12-weeks intervention

• Symptoms of anxiety - BAI

  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).

  After one year follow-up

• Symptoms of Generalized Anxiety Disorder - GAD-7

  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

  At study start

• Symptoms of Generalized Anxiety Disorder - GAD-7

  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

  After 12-weeks intervention

• Symptoms of Generalized Anxiety Disorder - GAD-7

  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

  After one year follow-up

• Symptoms of anxiety - HAD

  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).

  At study start

• Symptoms of anxiety - HAD

  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).

  After 12-weeks intervention

• Symptoms of anxiety - HAD

  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).

  After one year follow-up

• Symptoms of inner tension - MADRS-S; question 2

  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.

  At study start

• Symptoms of inner tension - MADRS-S; question 2

  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.

  After 12-weeks intervention

• Symptoms of inner tension - MADRS-S; question 2

  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.

  After one year follow-up

Secondary Outcomes (57)

• Symptoms of depression - MADRS-S

  At study start

• Symptoms of depression - MADRS-S

  After 12-weeks intervention

• Symptoms of depression - MADRS-S

  After one year follow-up

• Symptoms of pain - PSQ

  At study start

• Symptoms of pain - PSQ

  After 12-weeks intervention

Study Arms (3)

PHYSBI: 12-week physical exercise program

EXPERIMENTAL

An individualized 12-week training program including 3 occasions/week of moderate-high intensity. It may also contain elements of high intensity, corresponding to 3.0-8.9 metabolic equivalents (METs), Borg Rating of Perceived Exertion (RPE) 12-17 and 60-94% of maximal heart rate. The intervention includes cardiorespiratory and resistance training where two sessions per week are group-sessions and one session per week is performed individually. A study physiotherapists will design individualized exercise programs during a single one-to-one session with the patients.

Behavioral: PHYSBI: a 12-week physical exercise program

Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion.

EXPERIMENTAL

A modified and digital development of the Health Lift, an evidence based lifestyle-intervention for health promotion and prevention in primary health care. This intervention will be executed together with care manager contact according to medical guidelines. The patient receives a material consisting of separate questionnaires dealing with dietary habits, smoking, alcohol habits, physical activity, stress, living conditions, waist-hip-ratio and well-being expressed as a life ladder, present and future. Results are then converted into a health profile and a counsellor indicated what could be offered individually or in groups depending on the participant's wishes. This person-centered method ia based on strengthening the individual's own chosen health promoting activities and support for participation in municipal facilities.

Behavioral: Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion.

Care as usual

NO INTERVENTION

Care as usual for anxiety disorders at the primary care centers.

Interventions

PHYSBI: a 12-week physical exercise program BEHAVIORAL

An individualized 12-week training program including 3 occasions/week of moderate-high intensity.

PHYSBI: 12-week physical exercise program

Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion. BEHAVIORAL

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.

Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of anxiety disorder (panic syndrome, 41.0; generalized anxiety, F41.1; mixed anxiety- and depression, F41.2 and F41.3; anxiety not otherwise specified, F41.9).
• Seeking care at primary care centers within the Region Västra Götaland.
• With or without ongoing treatment with psychoactive medication (antidepressants or anxiolytics).

You may not qualify if:

• Pregnancy
• Physical difficulties in performing a physical exercise program
• Pathological electrocardiogram
• Low BMI (under 17.5)
• Ongoing alcohol/substance abuse
• Ongoing exhaustion disorder or psychotic disorder
• Newly discovered (within 6 months) atrial fibrillation
• High suicide risk as assessed by the general practitioner
• Limited knowledge in the Swedish language.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (1)

School of Public Health and Community Medicine, Institute of Medicine, University of Gothenburg

Gothenburg, 41320, Sweden

RECRUITING

Related Publications (6)

• Briggs A, Sculpher M, Claxton K. Decision modelling for health economic evaluation: Oup Oxford; 2006.

  BACKGROUND

• Drummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes: Oxford university press; 2015.

  BACKGROUND

• Sandheimer C, Bjorkelund C, Hensing G, Mehlig K, Hedenrud T. Implementation of a care manager organisation and its association with antidepressant medication patterns: a register-based study of primary care centres in Sweden. BMJ Open. 2021 Mar 5;11(3):e044959. doi: 10.1136/bmjopen-2020-044959.

  PMID: 33674375 BACKGROUND

• Nyberg J, Henriksson M, Aberg ND, Wall A, Eggertsen R, Westerlund M, Danielsson L, Kuhn HG, Waern M, Aberg M. Effects of exercise on symptoms of anxiety, cognitive ability and sick leave in patients with anxiety disorders in primary care: study protocol for PHYSBI, a randomized controlled trial. BMC Psychiatry. 2019 Jun 10;19(1):172. doi: 10.1186/s12888-019-2169-5.

  PMID: 31182054 BACKGROUND

• Batelaan NM, Seldenrijk A, Bot M, van Balkom AJ, Penninx BW. Anxiety and new onset of cardiovascular disease: critical review and meta-analysis. Br J Psychiatry. 2016 Mar;208(3):223-31. doi: 10.1192/bjp.bp.114.156554.

  PMID: 26932485 BACKGROUND

• A N. 3.5.3 Omfattning - vad går att säga? God och nära vård - Rätt stöd till psykisk hälsa. Betänkande av utredningen Samordnad utveckling för god och nära vård. In: 2021:6 SouS, editor. Stockholm 2021: ISBN 978-91-525-0019-4; 2021. p. 164-6.

  BACKGROUND

Related Links

• Webpage for the study (in Swedish)

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Maria Åberg, PhD, MD

  School of Public Health and Community Medicine, University of Gothenburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Åberg, PhD, MD

CONTACT

+46 (0)709668274; maria.aberg@gu.se

Jenny Nyberg, PhD

CONTACT

+46 (0)702180801; jenny.nyberg@neuro.gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A clinical intervention with a matched design and parallel arms.

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 4, 2024
• Study Start: March 17, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 15, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)