A Group Intervention for Promoting Health-related Habits (LEV-G)

NCT06404632 | Recruiting

• 1 other identifier: The LEV Project (group)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Health-related habits influences mental and physical health. Still, treatment of health-related habits, which can help to remedy health problems, is often not done at all or very superficially. Multiple guidelines emphasize the importance of prioritizing health-related habits, but there is a lack of implemented models. To solve this, the investigators have developed a transdiagnostic, interprofessional material intended for several care settings. The Lev-g intervention is intended for groups. There is also an individual version of Lev that has its on registration in Clinical Trails.

Conditions

Life Style; Health-Related Behavior; Disabilities Mental; Disability Physical; Acceptability of Health Care

Outcome Measures

Primary Outcomes (1)

• Completion rate participants

  How many of the participants that started using Lev (i.e., completing screening with Lev-s) completed Lev (i.e., completing, 3 out of 4 session)

  within 3-4 months

Secondary Outcomes (22)

• Level of treatment credibility participants

  Before and after taking part in Lev (after refers to completing the three sessions i.e, not including the booster session after three months). I.e within 6 weeks

• Level of treatment credibility healthcare workers

  Before and after taking part in Lev (after refers to completing the three sessions i.e, not including the booster session after three months)I.e within 6 weeks

• Treatment satisfaction participants (individual sessions)

  After completing the first session in Lev. An average of 1-2 weeks from baseline

• Treatment satisfaction participants (individual sessions)

  After completing the second session in Lev. An average of 2-3 weeks from baseline

• Treatment satisfaction participants (individual sessions)

  After completing the third session in Lev. An average of 3-4 weeks from baseline

Study Arms (1)

Lev-g (group intervention)

EXPERIMENTAL

Lev-g includes three sessions + a booster session using psychoeducation, motivational interviewing, and applied behavioral analyses. Lev-g is done in groups to enable support and tips from others. There is no control condition. Only one arm to test feasibility.

Behavioral: Lev-g

Interventions

Lev-g BEHAVIORAL

Lev-g includes three sessions + a booster session using psychoeducation, motivational interviewing, and applied behavioral analyses. Lev-g is done in groups to enable support and tips from others.

Lev-g (group intervention)

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• both adults with and without disabilities recruited from different healthcare contexts.

You may not qualify if:

• Intellectual disability of the degree where the participant is not able to follow the protocol in Lev.
• Insufficient command of the Swedish language/ unable to understand the content.
• Severe psychiatric comorbidity that makes participation difficult (e.g. severe depression, severe suicidality, severe anxiety, ongoing psychosis, manic episode), other circumstances that could make participation hard (e.g. homelessness).

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator
• Promobilia Foundation: collaborator

Study Sites (1)

Region Stockholm

Stockholm, Stockholm, Sweden, 104 31, Sweden

RECRUITING

MeSH Terms

Conditions

Health Behavior; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Behavior; Treatment Adherence and Compliance

Study Officials

• Douglas Sjöwall, PhD

  Region Stockholm

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Douglas Sjöwall, PhD

CONTACT

+46 (0)739568658; douglas.sjowall@ki.se

Joakim Lavesson, Bachelor

CONTACT

+46 8 123 350 01; joakim.lavesson@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Associate professor

Model Details: Feasibility trial with pre, peri, post and follow-up measurements

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 8, 2024
• Study Start: April 12, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)