A Transdiagnostic Intervention for Health-related Habits (LEV)

Region Stockholm

Status: Completed

Conditions: Mental Health Wellness; Quality of Life; Feasibility; Life Style; Intervention; Disabilities Physical; Disability Physical; Health-Related Behavior

Treatments: Behavioral: Lev

Study type: Interventional

Funder types: Other

Identifiers

NCT05889936

The LEV Project

Details and patient eligibility

About

Research problem and specific questions: Health-related habits influences mental and physical health. Still, screening and treatment of health-related habits, which can help to remedy health problems, is not done at all or very superficially. National 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.

Study 1: Is LEV a feasible intervention in different healthcare contexts? Study 2: A functional roadmap to healthier habits: A thematic analysis of themes form the functional analysis of unhealthy and healthy lifestyle behavior in adults with disabilities This study will use data from study 1.

Full description

Lev is a brief, transdiagnostic, interprofessional intervention targeting health-related habits that is intended for several care settings.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:

1. Eligibility to participate - how many of the healthcare workers that had received training in Lev started using it within 6 months? How many participants that were offered Lev agreed to take part in the intervention?

2. What were the reasons for not taking part or not completing Lev? Healthcare workers administering Lev will ask the declining participants for reasons to not take part in the intervention.

3. How many sessions and homework assignments did the participants complete? Lev includes screening (Lev-s), three sessions and two pre-specified home assignments. The administrating healthcare worker fills in completed sessions and assignments in the case report form. We will set the time limit to 6 months to complete the three sessions including all homework assignments.

4. Were there any differences between healthcare professions regarding how the applied behavioral analysis was performed (e.g., were there any differences regarding strategies suggested to the participant)?

   During session 2, a functional behavioral analysis is performed to generate strategies to help the participant reach their goal. The investigators will conduct a thematic analysis to identify themes for each healthcare profession administrating Lev. This will answer questions regarding if it is possible to conduct this type of analysis in Lev or if further adjustments are needed.

5. 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.

6. Was there any part of Lev that was perceived less satisfactory by participants and healthcare workers? A thematic analysis (Braun et al., 2004) will be performed to extract what was perceived as useful and to identify areas of improvement. This will be done both for participants and the healthcare workers.

7. Do the intervention lead to adverse events?

8. Do Lev lead to healthier habits?

9. To what extent were individual goals met?

10. Did Lev lead to increased quality of life?

Study 2:

1. What general themes underlying unhealthy and healthy habits can be found in individuals with disabilities?
2. How do themes vary for specific living habits?
3. How do themes vary for specific disabilities?
4. How do themes for questions b and c vary depending on sex?

Enrollment: 36 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Study 1 and 2 will include 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: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Treatment with the Lev-intervention

Experimental group

Description:

Screening of health-related habits using Lev-s + a three step/session intervention including the standard Lev protocol. Typically given over 10-20 weeks.

Treatment:

Behavioral: Lev