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

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00008745
• Date of registration: 10/06/2015
• Prospective Registration: No
• Primary sponsor: Karolinska Institutet
• Public title: Physical exercise and internet-based cognitive behavioral therapy in the treatment of depression (Regassa): a multi-centre, single blind, randomized controlled trial.
• Scientific title: Physical exercise and internet-based cognitive behavioral therapy in the treatment of depression (Regassa): a multi-centre, single blind, randomized controlled trial. - Regassa
• Date of first enrolment: 14/02/2011
• Target sample size: 930
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00008745
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Yvonne Forsell
• Affiliation: Karolinska Institutet

• Name: Yvonne Forsell
• Affiliation: Karolinska Institutet

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

Age minimum: 18 Years
Age maximum: 67 Years
Gender: All

Health Condition(s) or Problem(s) studied

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

F41.1

F42.8

Depressive episode

Generalized anxiety disorder

Post-traumatic stress disorder

Recurrent depressive disorder

Other obsessive-compulsive disorders

F40.1

F43.1

Social phobias

Intervention(s)

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 were undertaken at ‘Friskis och Svettis’ a modern health club and gymnasium with multiple locations throughout Sweden. Each exercise session lasted 60 minutes and typically included between 5 and 20 participants. As an incentive, all patients were provided free gym memberships for 12 weeks. Exercise compliance was monitored through weekly face-to-face meetings with a personal trainer, nurse or similar health professional. Patients who failed to attend this meeting were contacted by the trainer with a phone call and encouraged to continue the exercise protocol (unless the patient indicated a preference to withdraw from the study). Reminder text messages were sent to patients who could not initially be contacted by phone.
Group 2: Patients randomized to ICBT received 12 weeks treatment through a secure website operated via the Stockholm County Council. Treatment involved the patient working through a self-help manual available on-line in the form of modules. The manual was mostly text based, but also included images and sound clips. Before commencing the treatment, all ICBT-participants received a short phone call from their assigned clinician (a psychologist) who explained the process. Initially, several on-line forms were completed to identify patient-specific mental health concerns. The basic modules completed during th

Primary Outcome(s)

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).

Secondary ID(s)

Karolinska clinical trial registry

Source(s) of Monetary Support

Vårdal stiftelsen

Councils: Stockholm, Skåne, Västra Götaland, Kronoberg, Blekinge and Västmanland

Brain Foundation

Ethics review

Status: Approved
Approval date: 01/12/2010
Contact:

[e-mail]

Stockholm regional ethical review board

[phone]

[e-mail]

Results

• Date Completed: 28/02/2014
• URL: http://drks.de/search/en/trial/DRKS00008745#studyResults