Clinical trial NCT05889936: A Transdiagnostic Intervention for Health-related Habits (LEV)
Official title: A Transdiagnostic Intervention for Health-related Habits (LEV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention
Life Style
Health-Related Behavior
Feasibility
Quality of Life
Disabilities Physical
Disability Physical
Mental Health Wellness
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2023-06-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility trial with pre, peri and post measurements
Primary purpose: TREATMENT

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?

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).

Primary outcomes:
measure: Study 1: Completion rate healthcare workers
timeFrame: 6 month after completing the training.
measure: Study 1: Completion rate participants
timeFrame: 6 month after starting the screening
measure: Study 1: Level of treatment credibility healthcare workers
timeFrame: Immediately after the intervention (mean time 20 weeks)
measure: Study 1: Level of treatment credibility participants
timeFrame: Immediately after the intervention (mean time 20 weeks)
measure: Study 1: Treatment satisfaction healthcare workers (individual sessions)
timeFrame: Immediately after completing session 1. An average of 1-2 months from baseline
measure: Study 1: Treatment satisfaction healthcare workers (individual sessions)
timeFrame: Immediately after completing session 2. An average of 2-4 months from baseline
measure: Study 1: Treatment satisfaction healthcare workers (individual sessions)
timeFrame: Immediately after completing session 3. An average of 4-8 months from baseline
measure: Study 1: Treatment satisfaction participants (individual sessions)
timeFrame: After completing the first module in Lev. An average of 1-2 months from baseline
measure: Study 1: Treatment satisfaction participants (individual sessions)
timeFrame: After completing the second module in Lev. An average of 2-4 month from baseline
measure: Study 1: Treatment satisfaction participants (individual sessions)
timeFrame: After completing the third module in Lev. An average of 4-8 month from baseline
measure: Study 1: Treatment satisfaction participants (the whole intervention)
timeFrame: Directly after completing the last treatment module in LEV (approximately at 10 weeks)
measure: Study 1: Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire
timeFrame: Directly after completing the last treatment module in LEV (approximately at 20 weeks).
measure: Study 1: Well-being before and after the intervention measures by The Evaluation Questionnaire
timeFrame: Directly after completing the last treatment module in LEV (approximately at 20 weeks)
measure: Study 1: Adverse events after the intervention
timeFrame: During the intervention up to week approximately week 20.
measure: Study 2: What general themes underlying unhealthy and healthy habits can be found in individuals with disabilities?
timeFrame: During the second step in Lev (Approximately at 5-10 weeks)"
Secondary outcomes:
measure: Study 1: Quality of life measured with WHOQOL-BREF.
timeFrame: Before and after taking part in Lev (after is approximately at 10-20 weeks
measure: Study 1: Do Lev lead to healthier habits?
timeFrame: Before and after taking part in Lev (after is approximately at 10-20 weeks
measure: Study 1: To what extent were individual goals met?
timeFrame: After completing the whole intervention (approximately at 10-20 weeks
measure: Study 2: How do the themes (e.g., situation, context, behavior, short term gratification) behind unhealthy habits vary for specific living habits?
timeFrame: During the second step in Lev (Approximately at 5-10 weeks)
measure: Study 2: How do the themes behind unhealthy habits vary for different disabilities?
timeFrame: During the second step in Lev (Approximately at 5-10 weeks)
measure: Study 2: How do the themes behind unhealthy habits vary depending on sex?
timeFrame: During the second step in Lev (Approximately at 5-10 weeks)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Region Stockholm, Habilitering & Hälsa
Study officials:
affiliation: Regions Stockholm
name: Douglas Sjöwall, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Region Stockholm
name: Joakim Lavesson, Bachelor
role: STUDY_CHAIR
References: