Clinical trial NCT06404632: A Group Intervention for Promoting Health-related Habits (LEV-G)
Official title: A Group Intervention for Promoting Health-related Habits in Individuals With Disabilities (LEV-G)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Life Style
Health-Related Behavior
Disabilities Mental
Disability Physical
Acceptability of Health Care
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
name: Promobilia Foundation
First posted: 2024-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility trial with pre, peri, post and follow-up measurements
Primary purpose: PREVENTION

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.

Detailed 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?

Eligibility criteria: 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).

Primary outcomes:
measure: Completion rate participants
timeFrame: within 3-4 months
Secondary outcomes:
measure: Level of treatment credibility participants
timeFrame: 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
measure: Level of treatment credibility healthcare workers
timeFrame: 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
measure: Treatment satisfaction participants (individual sessions)
timeFrame: After completing the first session in Lev. An average of 1-2 weeks from baseline
measure: Treatment satisfaction participants (individual sessions)
timeFrame: After completing the second session in Lev. An average of 2-3 weeks from baseline
measure: Treatment satisfaction participants (individual sessions)
timeFrame: After completing the third session in Lev. An average of 3-4 weeks from baseline
measure: Treatment satisfaction participants (individual sessions)
timeFrame: After completing the booster session in Lev. An average of 3-4 month from baseline
measure: Treatment satisfaction participants (the three sessions)
timeFrame: Directly after completing the last treatment module in LEV (approximately at 3-4 weeks from baseline)]
measure: Treatment satisfaction participants (the whole intervention including the booster session)
timeFrame: Directly after completing the last treatment module in LEV (approximately at 3-4 month from baseline)]
measure: Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire for participants
timeFrame: Directly after completing the third session in LEV (approximately at 3-4 weeks from baseline)]
measure: Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire for participants
timeFrame: Directly after completing the booster session in LEV (approximately at 3-4 month from baseline)]
measure: Treatment satisfaction healthcare workers (individual sessions)
timeFrame: After completing the first session in Lev. An average of 1-2 weeks from baseline
measure: Treatment satisfaction healthcare workers (individual sessions)
timeFrame: After completing the first session in Lev. An average of 2-3 weeks from baseline
measure: Treatment satisfaction healthcare workers (individual sessions)
timeFrame: After completing the first session in Lev. An average of 3-4 weeks from baseline
measure: Treatment satisfaction healthcare workers (individual sessions)
timeFrame: After completing the first session in Lev. An average of 3-4 months from baseline
measure: Well-being before and after the intervention measures by The Evaluation Questionnaire
timeFrame: Directly after completing the third treatment module in LEV (approximately at 3-4 weeks)
measure: Well-being before and after the intervention measures by The Evaluation Questionnaire
timeFrame: Directly after completing the booster session module in LEV (approximately at 3-4 months)
measure: Adverse events after the intervention
timeFrame: During the intervention up to week approximately 3-4 months
measure: To what extent were individual goals met?
timeFrame: Directly after completing the third treatment module in LEV (approximately at 3-4 weeks)
measure: To what extent were individual goals met?
timeFrame: Directly after completing the booster session module in LEV (approximately at 3-4 months)
measure: Self-efficacy for promoting health behaviors for their children
timeFrame: Directly after completing the third session in LEV (approximately at 3-4 weeks)
measure: Self-efficacy for promoting health behaviors for their children
timeFrame: Directly after completing the booster session in LEV (approximately at 3-4 month)
measure: Do Lev lead to healthier habits?
timeFrame: Before and after taking part in Lev (after is after the third, 3-4 weeks, as wells as after the booster session, 3-4 month)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Region Stockholm
state: Stockholm, Sweden
Study officials:
affiliation: Region Stockholm
name: Douglas Sjöwall, PhD
role: PRINCIPAL_INVESTIGATOR
References: