Region Stockholm, Habilitering & Hälsa
Stockholm, 104 31, Sweden
NCT Number: NCT05889936
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Stockholm, 104 31, Sweden
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:
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.
Study 2:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 month after completing the training.
how many of the healthcare workers that had received training in Lev started using it within 6 months
Time frame: 6 month after starting the screening
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)
Time frame: Immediately after the intervention (mean time 20 weeks)
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.
Time frame: Immediately after the intervention (mean time 20 weeks)
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.
Time frame: Immediately after completing session 1. An average of 1-2 months from baseline
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.
Time frame: Immediately after completing session 2. An average of 2-4 months from baseline
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.
Time frame: Immediately after completing session 3. An average of 4-8 months from baseline
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.
Time frame: After completing the first module in Lev. An average of 1-2 months from baseline
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.
Time frame: After completing the second module in Lev. An average of 2-4 month from baseline
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.
Time frame: After completing the third module in Lev. An average of 4-8 month from baseline
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.
Time frame: Directly after completing the last treatment module in LEV (approximately at 10 weeks)
Treatment satisfaction will be evaluated after competing the whole intervention using Patient Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
The participants also rated the course as a whole following the school grading system ''Failed,'' ''Passed,'' ''Passed with distinction,'' and ''Passed with special
Time frame: Directly after completing the last treatment module in LEV (approximately at 20 weeks).
The treatment satisfaction questionnaire also included open questions that will be analyses using a qualitative thematic approach including the following questions:
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.
Time frame: Directly after completing the last treatment module in LEV (approximately at 20 weeks)
("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)
Time frame: During the intervention up to week approximately week 20.
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.
Time frame: During the second step in Lev (Approximately at 5-10 weeks)"
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.
Time frame: Before and after taking part in Lev (after is approximately at 10-20 weeks
Is Quality of life affected when completing Lev? The intervention group fill in WHOQOL-BREF at baseline and follow-up. 5 level scale where high levels indicate higher quality of life.
Time frame: Before and after taking part in Lev (after is approximately at 10-20 weeks
The Lev-s will be used to measures living habits before and after taking part in Lev. The scale includes 4 levels where higher levels indicate healthier habits.
Time frame: After completing the whole intervention (approximately at 10-20 weeks
During session 1 in the intervention, individual goals are set. The healthcare worker assesses to what extent the goals have been met using the goal attainment scale. 5 point scale where high vales indicate that goals have been reached to a higher extent.
Time frame: During the second step in Lev (Approximately at 5-10 weeks)
To understand what what underlying behavior and situations that underlies specific unhealthy habits investigators will conduct exploratory qualitative thematic analysis.
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.
Time frame: During the second step in Lev (Approximately at 5-10 weeks)
To understand what underlying behavior and situations that underlies unhealthy habits in different groups of disabilities we will conduct exploratory qualitative thematic analysis.
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.
Time frame: During the second step in Lev (Approximately at 5-10 weeks)
To understand if underlying behavior and situations that underlies unhealthy habits differ depending on sex we will conduct the thematic analysis also separately for sexes.
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.
Region Stockholm
Other Gov
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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