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

Region Stockholm

Status: Enrolling

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

Treatments: Behavioral: Lev-g

Study type: Interventional

Funder types: Other

Identifiers

NCT06404632

The LEV Project (group)

Details and patient eligibility

About

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.

Full description

Lev is a brief, transdiagnostic, interprofessional intervention targeting health-related habits that is intended for several care settings. The main population intended is individuals with neurodevelopmental disorders or parents or close relations to children with disabilities. This study will therefore be open for participants recruited from several types of healthcare services in Sweden.

Study 1: The feasibility trial investigates the following questions:

Completion: How many participants that started Lev completed the intervention? What were the reasons for not not completing Lev? How many sessions did the participants complete? Lev includes screening (Lev-s), three sessions + one booster session.

Level of acceptability: Was Lev perceived as creditable and satisfactory by healthcare workers and participants? Treatment credibility will be measured before Lev and after the last session for both participants and healthcare workers. Treatment satisfaction will be evaluated after each session and after the intervention is completed. Session evaluations will be done by both participants and healthcare workers.

Do the intervention lead to adverse events? To what extent were individual goals met?

Enrollment: 30 estimated patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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).

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Lev-g (group intervention)

Experimental group

Description:

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.

Treatment:

Behavioral: Lev-g