A Transdiagnostic Intervention for Health-related Habits (LEV)

NCT ID: NCT05889936

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-25
• Study Completion Date: 2023-12-21

Brief Summary

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.

Detailed 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?

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with the Lev-intervention

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

Group Type: EXPERIMENTAL

Lev

Intervention Type: BEHAVIORAL

Lev includes three sessions using psychoeducation, motivational interviewing, and applied behavioral analyses. Lev also include two homework assignments. The second session can be repeated if needed. Lev-s and Lev are described in two manuals.

Interventions

Lev

Lev includes three sessions using psychoeducation, motivational interviewing, and applied behavioral analyses. Lev also include two homework assignments. The second session can be repeated if needed. Lev-s and Lev are described in two manuals.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Region Stockholm

OTHER_GOV

Sponsor Role: lead

Responsible Party

Douglas Sjowall

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas Sjöwall, PhD

Role: PRINCIPAL_INVESTIGATOR

Regions Stockholm

Joakim Lavesson, Bachelor

Role: STUDY_CHAIR

Region Stockholm

Locations

Region Stockholm, Habilitering & Hälsa

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

The LEV Project

Identifier Type: -

Identifier Source: org_study_id