A Transdiagnostic Intervention for Health-related Habits (LEV)

NCT05889936 | Completed

• 1 other identifier: The LEV Project
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (15)

• Study 1: Completion rate healthcare workers

  how many of the healthcare workers that had received training in Lev started using it within 6 months

  6 month after completing the training.

• Study 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, 2 out of 3 steps)

  6 month after starting the screening

• Study 1: Level of treatment credibility healthcare workers

  Was Lev perceived as creditable and by healthcare workers using Treatment and Credibility Scale. Four items for credibility and one for expectation on a 10 point Likert scale where higher values indicate higher credibility.

  Immediately after the intervention (mean time 20 weeks)

• Study 1: Level of treatment credibility participants

  Was Lev perceived as creditable and by participants using Treatment and Credibility Scale . Four items for credibility and one for expectation on a 10 point Likert scale where higher values indicate higher credibility.

  Immediately after the intervention (mean time 20 weeks)

• Study 1: Treatment satisfaction healthcare workers (individual sessions)

  Treatment satisfaction will be evaluated after session 1 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction. 1. The content of this session feels relevant 2. The degree of difficulty in conveying the content of the session is at a reasonable level for me as a therapist 3. Is there something else you would like to add?

  Immediately after completing session 1. An average of 1-2 months from baseline

• Study 1: Treatment satisfaction healthcare workers (individual sessions)

  Treatment satisfaction will be evaluated after session 2 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction. 1. The content of this session feels relevant 2. The degree of difficulty in conveying the content of the session is at a reasonable level for me as a therapist 3. Is there something else you would like to add?

  Immediately after completing session 2. An average of 2-4 months from baseline

• Study 1: Treatment satisfaction healthcare workers (individual sessions)

  Treatment satisfaction will be evaluated after session 3 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction. 1. The content of this session feels relevant 2. The degree of difficulty in conveying the content of the session is at a reasonable level for me as a therapist 3. Is there something else you would like to add?

  Immediately after completing session 3. An average of 4-8 months from baseline

• Study 1: Treatment satisfaction participants (individual sessions)

  Treatment satisfaction will be evaluated after session 1 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction. 1. After the meeting today, my knowledge of how I can change my lifestyle have increased. 2. I will benefit from what we talked about during the meeting today 3. The content of the meeting felt relevant based on my own experiences 4. I understood the advice and strategies I was given that will help my change mine lifestyle habits 5. I feel confident in how to use the advice and strategies 6. I will use the advice and strategies 7. I was listened to, the therapist understood my situation 8. I was involved and helped to come up with suggestions for how I can reach my goals 9. Is there something else you would like to add?

  After completing the first module in Lev. An average of 1-2 months from baseline

• Study 1: Treatment satisfaction participants (individual sessions)

  Treatment satisfaction will be evaluated after session 2 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction. 1. After the meeting today, my knowledge of how I can change my lifestyle have increased. 2. I will benefit from what we talked about during the meeting today 3. The content of the meeting felt relevant based on my own experiences 4. I understood the advice and strategies I was given that will help my change mine lifestyle habits 5. I feel confident in how to use the advice and strategies 6. I will use the advice and strategies 7. I was listened to, the therapist understood my situation 8. I was involved and helped to come up with suggestions for how I can reach my goals 9. Is there something else you would like to add?

  After completing the second module in Lev. An average of 2-4 month from baseline

• Study 1: Treatment satisfaction participants (individual sessions)

  Treatment satisfaction will be evaluated after session 3 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction. 1. After the meeting today, my knowledge of how I can change my lifestyle have increased. 2. I will benefit from what we talked about during the meeting today 3. The content of the meeting felt relevant based on my own experiences 4. I understood the advice and strategies I was given that will help my change mine lifestyle habits 5. I feel confident in how to use the advice and strategies 6. I will use the advice and strategies 7. I was listened to, the therapist understood my situation 8. I was involved and helped to come up with suggestions for how I can reach my goals 9. Is there something else you would like to add?

  After completing the third module in Lev. An average of 4-8 month from baseline

• Study 1: Treatment satisfaction participants (the whole intervention)

  Treatment satisfaction will be evaluated after competing the whole intervention using Patient Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction. 1. As a whole, the Lev has been clearly focused on how I can live healthier 2. My knowledge of how I can have healthier habits has increased 3. I can better deal with problems connected to my health-related habits 4. I have had the opportunity to contribute opinions during the Lev 5. I would consider participating in a similar interventions in the future The participants also rated the course as a whole following the school grading system ''Failed,'' ''Passed,'' ''Passed with distinction,'' and ''Passed with special

  Directly after completing the last treatment module in LEV (approximately at 10 weeks)

• Study 1: Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire

  The treatment satisfaction questionnaire also included open questions that will be analyses using a qualitative thematic approach including the following questions: 1. I feel that participating in Lev helped me in these ways 2. How could the Lev have been better? 3. What could I have done differently myself? 4. Is there anything else you would like to add? A qualitative, thematic analysis will be performed to identify more general themes. There is not a template or scale to extract the themes. One rater suggest categories based on the similarity of answers. Another rater organizes the answers in the suggested themes. To be considered a theme, there must be over 85% similarity between raters.

  Directly after completing the last treatment module in LEV (approximately at 20 weeks).

• Study 1: Well-being before and after the intervention measures by The Evaluation Questionnaire

  ("How would you rate your well-being prior to the intervention?", "How would you rate your current well-being") at T1 and T2 on a scale 1-10 (1= very poor, 10= very good)

  Directly after completing the last treatment module in LEV (approximately at 20 weeks)

• Study 1: Adverse events after the intervention

  Adverse events will be defined as spontaneous oral complaints or instances when patients stated that they experienced negative or unwanted effects during the intervention period. Serious adverse events will be defined as events that involved hospital care/hospitalization, etc. due to the intervention.

  During the intervention up to week approximately week 20.

• Study 2: What general themes underlying unhealthy and healthy habits can be found in individuals with disabilities?

  Healthcare workers are instructed to enter what strategies they gave to the participant. Strategies from step 2 (page 16 workbook). The themes are extracted based on answers to the following two questions: This is what others can do to help me: ....... I can do this myself:... A qualitative, thematic analysis will be performed to identify more general themes. There is not a template or scale to extract the themes. One rater suggest categories based on the similarity of answers. Another rater organizes the answers in the suggested themes. To be considered a theme, there must be over 85% similarity between raters.

  During the second step in Lev (Approximately at 5-10 weeks)"

Secondary Outcomes (6)

• Study 1: Quality of life measured with WHOQOL-BREF.

  Before and after taking part in Lev (after is approximately at 10-20 weeks

• Study 1: Do Lev lead to healthier habits?

  Before and after taking part in Lev (after is approximately at 10-20 weeks

• Study 1: To what extent were individual goals met?

  After completing the whole intervention (approximately at 10-20 weeks

• Study 2: How do the themes (e.g., situation, context, behavior, short term gratification) behind unhealthy habits vary for specific living habits?

  During the second step in Lev (Approximately at 5-10 weeks)

• Study 2: How do the themes behind unhealthy habits vary for different disabilities?

  During the second step in Lev (Approximately at 5-10 weeks)

Study Arms (1)

Treatment with the Lev-intervention

EXPERIMENTAL

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

Behavioral: Lev

Interventions

Lev 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.

Treatment with the Lev-intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study 1 and 2 will include 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

Study Sites (1)

Region Stockholm, Habilitering & Hälsa

Stockholm, 104 31, Sweden

Location

Related Publications (1)

• Sjowall D, Brar A, Fladvad A, Langh U, Hirvikoski T. Feasibility trial of a transdiagnostic individual lifestyle evaluation and intervention (Lev-i) for health behavior change. PLoS One. 2026 Jan 12;21(1):e0339500. doi: 10.1371/journal.pone.0339500. eCollection 2026.

  PMID: 41525256 DERIVED

MeSH Terms

Conditions

Health Behavior

Interventions

Levamisole

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Douglas Sjöwall, PhD

  Regions Stockholm

  PRINCIPAL INVESTIGATOR

• Joakim Lavesson, Bachelor

  Region Stockholm

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

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

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: June 5, 2023
• Study Start: January 25, 2023
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)