Substance Use DisorderNCT03055351
Stop&Go: an Intervention Program to Promote Healthy and Active Lifestyles Among Patients With Substance Use Disorders
A study testing Stop&Go Intervention in people with Substance Use Disorder and Motivation, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorder, Motivation
- What is being tested?
- Stop&Go Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 17 Feb 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Mental disorders that could hinder patient assessment
- Difficulty to answer the survey due to limited literacy or poor Spanish language proficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stop&Go: an Intervention Program to Promote Healthy and Physically Active Lifestyles Among Patients With Substance Use Disorders
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.
Read the 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.
- Conditions
- Substance Use Disorder, Motivation
- Being tested
- Stop&Go Intervention
- Keywords
- Exercise motivation, Psychological well-being, Healthy living, Physical activity, Autonomy support, Self-determination theory
- Medical subject headings
- Substance-Related Disorders, Psychological Well-Being, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stop&Go InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants will complete the outcome measures but will not receive any intervention. |
| Stop&Go Intervention | Experimental | 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. Receives: Behavioral: Stop&Go Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately upon admission to the centre, as well as upon successful discharge, measured up to a total of 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start17 Feb 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055351
- Sponsor's protocol ID
- IIBSP-STO-2016-80
- Status last verified
- Feb 2019
- First submitted
- 25 Jan 2017
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stop&Go: an Intervention Program to Promote Healthy and Physically Active Lifestyles Among Patients With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT03055351
- Acronym / sponsor ID
- IIBSP-STO-2016-80
- Conditions
- Substance Use Disorder, Motivation
- Keywords
- Exercise motivation, Psychological well-being, Healthy living, Physical activity, Autonomy support, Self-determination theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants will complete the outcome measures but will not receive any intervention. |
| Stop&Go Intervention | Experimental | Behavioral: Stop&Go InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Mental disorders that could hinder patient assessment
- Difficulty to answer the survey due to limited literacy or poor Spanish language proficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stop&Go InterventionStop\&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. | Behavioural | Stop&Go Intervention |
Primary outcome
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).
Time frame: Immediately upon admission to the centre, as well as upon successful discharge, measured up to a total of 10 days.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stop&Go Intervention in people with Substance Use Disorder and Motivation, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Immediately upon admission to the centre, as well as upon successful discharge, measured up to a total of 10 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.