Motivational Multicomponent Lifestyle Interventions as a Supportive Treatment for Depression in Primary Health Care

ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKuopio University Hospital

About this trial

The investigators aim to examine whether a motivational multicomponent lifestyle intervention as a supportive treatment for depression has a beneficial effect on recovery from depression in a primary health care setting.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adults ≥ 18 years

depression (ICD-10, F32-F33)

Beck Depression Inventory (BDI-1A) ≥ 10 points

the initiation of treatment in a primary health care center

Disqualifiers

bipolar disorder

psychosis

substance abuse

pregnancy or lactation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Motivational multicomponent lifestyle intervention + Treatment as usual

    Behavioral

    Study intervention and treatment as usual The study intervention is a multicomponent lifestyle intervention that targets exercise, diet, and stress management, and is conducted by motivational interviewing. The study nurse provides the study intervention. The intervention is conducted by motivational interviewing and includes the key elements of lifestyle interventions identified as effective (assessment of behavior at the baseline, giving information and advising, individualized goal setting, setting an action plan, monitoring a behavioral change, and giving feedback). The intervention consists of individual appointments (2 x 45-60 min) and a telephone session ( 2 x 15 min) for three months. The participants receive a short educational guide (A4) on the lifestyle behavior recommendations.

  • Treatment as usual

    Other intervention

    Treatment as usual

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in Beck Depression Inventory (BDI) scores

Depressive symptoms

Time frame
Change from baseline at 3, 12 and 24 months
2

Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores

Mental Wellbeing

Time frame
Change from baseline at 3, 12 and 24 months
3

Change in 15D scores

Health-Related Quality of Life

Time frame
Change from baseline at 3, 12 and 24 months

Secondary outcomes

1

Change in Perceived Stress Scale (PSS-10) scores

Stress

Time frame
Change from baseline at 3, 12 and 24 months
2

Change in Insomnia Severity Index (ISI) scores

Insomnia

Time frame
Change from baseline at 3, 12 and 24 months
3

Change in Numeric Rating Scale for pain

Pain

Time frame
Change from baseline at 3, 12 and 24 months
4

Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores

Anxiety

Time frame
Change from baseline at 3, 12 and 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kuopio University Hospital

Lead sponsor

University of Eastern Finland

Collaborator

City of Kuopio

Collaborator

University of Oslo

Collaborator