MentalNCT03047356
Sleep Intervention
A study testing "If-then" plans in people with Mental, run by University of Manchester.
Trial summary
A trial that tests whether implementation intentions improve sleep among adoelescents. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental
- What is being tested?
- "If-then" plans
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2016to 6 Apr 2016
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 12-16 years
Who cannot join
- Unable or unwilling to complete the question
About this study
Official title: Effects of "If-then" Plans ("Implementation Intentions") on Adolescent Sleep
A trial that tests whether implementation intentions improve sleep among adoelescents.
- Conditions
- Mental
- Being tested
- "If-then" plans, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"If-then" plansBehavioural
"If-then" plans (or "implementation intentions") involve linking in memory critical situations (e.g., temptations) with appropriate responses (e.g., substitution)
ControlOther
Exposure to critical situations (e.g., temptations) and appropriate responses (e.g., substitution) but not linked in memory
| Study group | Role | What they receive |
|---|---|---|
| First-person "if-then" plan | Experimental | Participants are asked to form "if-then" plans and the instructions are presented in the first person ("if I...then I..."). "Ifs" are critical situations, "thens" are appropriate responses. Receives: Behavioral: "If-then" plans |
| Second-person "if-then" plan | Experimental | Participants are asked to form "if-then" plans and the instructions are presented in the second person ("if you...then you..."). "Ifs" are critical situations, "thens" are appropriate responses. Receives: Behavioral: "If-then" plans |
| Control | Placebo comparator | Participants are presented with "ifs "(critical situations) and "thens" but are not asked to form "if-then" plans. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving recommended sleep levels
The main outcome measure was adapted from the Pittsburgh Sleep Quality Index (Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989), and was designed to tap both quantity and quality of sleep. Sleep quantity was assessed by asking: "How many hours of actual sleep do you normally get on a night before school? _________ hours," "What time do you normally go to bed on a night before school? __________ pm," and "What time do you normally get up on a school day? __________ am."
Measured: 1 month
Secondary outcomes (2)
Self-regulation
Sniehotta, Nagy, and Scholz's (2006) six items were used to capture three facets of action control (Karoly, 1993) on 7-point (+1 to +7) strongly disagree-strongly agree scales. (e.g., "During the last month I constantly monitored my sleep on the nights before school")
Measured: 1 month
Habit
Gardner et al.'s (2012) self-report behavioral automaticity index, which consists of four items measured on 7-point strongly disagree-strongly agree scales. The items are: "Getting 9 hours' sleep on the nights before school is something I do automatically," "Getting 9 hours' sleep on the nights before school is something I do without thinking," "Getting 9 hours' sleep on the nights before school is something I do without having to consciously remember," and "Getting 9 hours' sleep on the nights before school is something I start doing before I realize I'm doing it."
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start4 Mar 2016
- Primary completion6 Apr 2016
- Study completion6 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MentalStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Armitage, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047356
- Sponsor's protocol ID
- Carding_1
- Status last verified
- Feb 2017
- First submitted
- 3 Feb 2017
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of "If-then" Plans ("Implementation Intentions") on Adolescent Sleep
- ClinicalTrials.gov ID
- NCT03047356
- Acronym / sponsor ID
- Carding_1
- Conditions
- Mental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 4 Mar 2016 (actual)
- Primary completion
- 6 Apr 2016 (actual)
- Study completion
- 6 Apr 2016 (actual)
- First posted
- 8 Feb 2017 (estimated)
- 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.
A trial that tests whether implementation intentions improve sleep among adoelescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First-person "if-then" plan | Experimental | Behavioral: "If-then" plansParticipants are asked to form "if-then" plans and the instructions are presented in the first person ("if I...then I..."). "Ifs" are critical situations, "thens" are appropriate responses. |
| Second-person "if-then" plan | Experimental | Behavioral: "If-then" plansParticipants are asked to form "if-then" plans and the instructions are presented in the second person ("if you...then you..."). "Ifs" are critical situations, "thens" are appropriate responses. |
| Control | Placebo comparator | Other: ControlParticipants are presented with "ifs "(critical situations) and "thens" but are not asked to form "if-then" plans. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Aged 12-16 years
Key exclusion criteria (1 listed)
- Unable or unwilling to complete the question
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 |
|---|---|---|
| "If-then" plans"If-then" plans (or "implementation intentions") involve linking in memory critical situations (e.g., temptations) with appropriate responses (e.g., substitution) | Behavioural | First-person "if-then" plan, Second-person "if-then" plan |
| ControlExposure to critical situations (e.g., temptations) and appropriate responses (e.g., substitution) but not linked in memory | Other | Control |
Primary outcome
Achieving recommended sleep levels
Time frame: 1 month
The main outcome measure was adapted from the Pittsburgh Sleep Quality Index (Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989), and was designed to tap both quantity and quality of sleep. Sleep quantity was assessed by asking: "How many hours of actual sleep do you normally get on a night before school? _________ hours," "What time do you normally go to bed on a night before school? __________ pm," and "What time do you normally get up on a school day? __________ am."
2 secondary outcomes
Self-regulation
Time frame: 1 month
Habit
Time frame: 1 month
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 8 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing "If-then" plans in people with Mental, run by University of Manchester.
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 1 inclusion and 1 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 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Achieving recommended sleep levels (time frame: 1 month). 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 8 Feb 2017.