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Physical exercise and internet-based cognitive behavioral therapy in the treatment of depression (Regassa): a multi-centre, single blind, randomized controlled trial.

Physical exercise and internet-based cognitive behavioral therapy in the treatment of depression (Regassa): a multi-centre, single blind, randomized controlled trial. - Regassa

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00008745
Enrollment
930
Registered
2015-06-10
Start date
2011-02-14
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F32 F33 F40.1 F42.8 F43.1 F41.1

Interventions

Group 1: Patients in the physical exercise group were randomized to one of three conditions: ‘light exercise’ which consisted of yoga or stretching classes with an emphasis on controlled breathing
‘moderate exercise’ - an intermediate level aerobics class
and ‘vigorous exercise’ – a higher intensity aerobics/strength-training and balance class. Patients were requested to complete the exercise classes 3 times per week for 12 weeks. All exercise classes

Sponsors

Karolinska Institutet
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 67 Years

Inclusion criteria

Inclusion criteria: Patients aged 18-67 years who scored >9 on the Patient Health Questionnaire (PHQ-9) were invited to participate in the trial.

Exclusion criteria

Exclusion criteria: Exclusion criteria were: a severe somatic illness, a primary alcohol or drug use disorder or a psychiatric diagnosis that required specialist treatment (e.g. psychosis).

Design outcomes

Primary

MeasureTime frame
Baseline, 3 months and 12 month follow-up. Depression severity (Montgomerg Åsberg Depression Rating Scale - MADRS), employment status and sick-leave. Current employment status was assessed by a single question with nine response alternatives: Employed, Business owner, Temporary work absence (education or childcare), Student, Disability pension, Aged pension, Current sick-leave (one month or more), Unemployed, and Unemployed work scheme. The first three items were coded ‘Employed’ and the last two ‘Unemployed’. A single item assessed current sick-leave (1 month or more).

Countries

Sweden

Contacts

Public ContactYvonne Forsell

Karolinska Institutet

yvonne.forsell@ki.se+46812337161

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 9, 2026