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Stop&Go: an Intervention Program to Promote Healthy and Active Lifestyles Among Patients With Substance Use Disorders

Primary Purpose

Substance Use Disorder, Motivation

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Stop&Go Intervention
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Substance Use Disorder focused on measuring Exercise motivation, Psychological well-being, Healthy living, Physical activity, Autonomy support, Self-determination theory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meeting DSM-V criteria for substance use disorder.
  • Request for treatment primarily based on substance detoxification.
  • Voluntary admission to an impatient detoxification centre
  • Age ≥ 18 years old.

Exclusion Criteria:

  • Mental disorders that could hinder patient assessment
  • Difficulty to answer the survey due to limited literacy or poor Spanish language proficiency.

Sites / Locations

  • Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Stop&Go Intervention

Arm Description

Participants will complete the outcome measures but will not receive any intervention.

Participants in this group will participate in an intervention aimed at promoting a healthy and physically active lifestyle. The intervention will be based on Self-determination theory postulates and will have two axes: training and motivation.

Outcomes

Primary Outcome Measures

Changes from patients' baseline exercise motivations at the moment of discharge, measured with the Behavioural Regulation in Exercise Questionnaire (BREQ-3; Wilson et al., 2006).
The BREQ-3 measures 6 different types of exercise regulations: intrinsic motivation, integrated reg., identified reg., introjected reg., external reg., amotivation. Participants will be included in the study as they begin their inpatient detoxification treatment and will finish their participation when they are successfully discharged from the centre. Exercise motivations will be measured at 2 time points (Time 1- patient's admission to the detoxification centre, Time 2- successful discharge from the centre), but is not possible to specify in advance the exact number of days between time points due to the following main reason: This study is conducted in an inpatient detoxification unit and consequently medical criteria will prevail in order to estimate the varying duration of treatments. In any case, according to the best clinical practice, detoxification treatments usually last 11-15 days and thus it is expected that at least 10 days elapse between the aforementioned 2 time points.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2017
Last Updated
February 28, 2019
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT03055351
Brief Title
Stop&Go: an Intervention Program to Promote Healthy and Active Lifestyles Among Patients With Substance Use Disorders
Official Title
Stop&Go: an Intervention Program to Promote Healthy and Physically Active Lifestyles Among Patients With Substance Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 17, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Stop&Go is an intervention program aimed at promoting a healthy and physically active lifestyle for patients requiring inpatient detoxification treatment. The program includes two different phases. Phase I is aimed at understanding the variables related with adherence to healthy lifestyle interventions. Phase II will use the knowledge obtained in Phase I to develop and evaluate an intervention based on Self-determination theory to promote healthy and physically active lifestyles for patients admitted to an inpatient detoxification centre. The Stop&Go intervention is hypothesized to help patients move towards a healthy lifestyle and thus, may bring about changes in patients' (1) knowledge acquired, (2) indicators of healthy habits (e.g., exercise motivation) and (3) psychological well-being and ill-being.
Detailed Description
In patients with substance use disorders, exercise could help in the treatment of substance addictions. Interventions focused on promoting physical activity and healthy lifestyle for patients in residential treatment centres and ambulatory settings have been developed in the last years. However, there is a lack of programs promoting a healthy and physically active lifestyle for patients requiring inpatient detoxification treatment. Thus, the plan is to develop an intervention program with such characteristics, namely "Stop&Go". Stop&Go includes two different phases. Phase I is aimed at understanding the variables related with adherence to healthy lifestyle interventions. Patients with substance use disorders will be invited to participate in focus groups (Study 1) and to respond to questionnaires (Study 2) assessing variables related to exercise and healthy habits (e.g., intention to be physically active). Phase II will use the knowledge obtained in Phase I to develop and evaluate an intervention to promote healthy and physically active lifestyle for patients admitted to an inpatient detoxification centre. The intervention will be based on Self-determination theory postulates and will have two axes: to educate and to motivate. Patients will participate in four practically-oriented training sessions, focused on (1) nutrition and oral hygiene, (2) sleep habits and self-care, (3) physical activity and exercise, and (4) smoking cessation. In addition, the entire inpatient detoxification centre will be adapted to encourage autonomous physical activity and to reinforce the ideas presented in the training sessions. The main strength of Stop&Go is expected to be the combination of perspectives included in its development (i.e., intervention led by an interdisciplinary team and based on patients' needs). The Stop&Go intervention is hypothesized to help patients move towards a healthy lifestyle and thus, may bring about changes in patients' (1) knowledge acquired, (2) variables related to healthy habits (e.g., exercise motivation) and (3) psychological well-being and ill-being.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorder, Motivation
Keywords
Exercise motivation, Psychological well-being, Healthy living, Physical activity, Autonomy support, Self-determination theory

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants will complete the outcome measures but will not receive any intervention.
Arm Title
Stop&Go Intervention
Arm Type
Experimental
Arm Description
Participants in this group will participate in an intervention aimed at promoting a healthy and physically active lifestyle. The intervention will be based on Self-determination theory postulates and will have two axes: training and motivation.
Intervention Type
Behavioral
Intervention Name(s)
Stop&Go Intervention
Intervention Description
Stop&Go intervention will be based on Self-determination theory. Patients will participate in four practically-oriented training sessions, focused on (1) nutrition and oral hygiene, (2) sleep habits and self-care, (3) physical activity and exercise, and (4) smoking cessation. In addition, the entire inpatient detoxification centre will be adapted to encourage autonomous physical activity and to reinforce the ideas presented in the training sessions.
Primary Outcome Measure Information:
Title
Changes from patients' baseline exercise motivations at the moment of discharge, measured with the Behavioural Regulation in Exercise Questionnaire (BREQ-3; Wilson et al., 2006).
Description
The BREQ-3 measures 6 different types of exercise regulations: intrinsic motivation, integrated reg., identified reg., introjected reg., external reg., amotivation. Participants will be included in the study as they begin their inpatient detoxification treatment and will finish their participation when they are successfully discharged from the centre. Exercise motivations will be measured at 2 time points (Time 1- patient's admission to the detoxification centre, Time 2- successful discharge from the centre), but is not possible to specify in advance the exact number of days between time points due to the following main reason: This study is conducted in an inpatient detoxification unit and consequently medical criteria will prevail in order to estimate the varying duration of treatments. In any case, according to the best clinical practice, detoxification treatments usually last 11-15 days and thus it is expected that at least 10 days elapse between the aforementioned 2 time points.
Time Frame
Immediately upon admission to the centre, as well as upon successful discharge, measured up to a total of 10 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meeting DSM-V criteria for substance use disorder. Request for treatment primarily based on substance detoxification. Voluntary admission to an impatient detoxification centre Age ≥ 18 years old. Exclusion Criteria: Mental disorders that could hinder patient assessment Difficulty to answer the survey due to limited literacy or poor Spanish language proficiency.
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Stop&Go: an Intervention Program to Promote Healthy and Active Lifestyles Among Patients With Substance Use Disorders

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