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

NCT05681767 | Recruiting

• 1 other identifier: KUH500SH07
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

• Change in Beck Depression Inventory (BDI) scores

  Depressive symptoms

  Change from baseline at 3, 12 and 24 months

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

  Mental Wellbeing

  Change from baseline at 3, 12 and 24 months

• Change in 15D scores

  Health-Related Quality of Life

  Change from baseline at 3, 12 and 24 months

Secondary Outcomes (9)

• Change in Perceived Stress Scale (PSS-10) scores

  Change from baseline at 3, 12 and 24 months

• Change in Insomnia Severity Index (ISI) scores

  Change from baseline at 3, 12 and 24 months

• Change in Numeric Rating Scale for pain

  Change from baseline at 3, 12 and 24 months

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

  Change from baseline at 3, 12 and 24 months

• Change in Blood lipid levels

  Change from baseline at 12 and 24 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Motivational multicomponent lifestyle intervention + treatment as usual

Behavioral: Motivational multicomponent lifestyle intervention + Treatment as usual

Control group

OTHER

Treatment as usual

Other: Treatment as usual

Interventions

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.

Intervention group

Treatment as usual OTHER

Treatment as usual

Control group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• bipolar disorder
• psychosis
• substance abuse
• pregnancy or lactation
• a long-term rehabilitative psychotherapy.

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Eastern Finland: collaborator
• City of Kuopio: collaborator
• University of Oslo: collaborator

Study Sites (1)

Kuopio Health Center

Kuopio, Finland

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Pekka Mäntyselkä

  University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pekka Mäntyselkä

CONTACT

+35850449436; pekka.mantyselka@uef.fi

Ulla Mikkonen

CONTACT

ulla.mikkonen@uef.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a 2-arm, randomized controlled clinical trial, in which participants are randomized to the study arms at an individual level. After the baseline data is collected, the study nurse (nurse 1), who conducts the baseline data collection, uses opaque capsules to randomize patients to the study arms.

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: January 12, 2023
• Study Start: November 21, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)