Can You Reduce Problematic Smartphone Use Through a Group Intervention: A Single Case Experimental Design

October 31, 2022 updated by: Canterbury Christ Church University
This study will develop and conduct an initial, single-case, mixed-methods evaluation of a brief group intervention for mild and moderate problematic phone use.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Kent
      • Tunbridge Wells, Kent, United Kingdom, TN1 2YG
        • Salomons Institute, Canterbury Christ Church University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Self-identifies as struggling with problematic smart phone use

Exclusion Criteria:

  • Actively experiencing suicidal or self-injurious thoughts, or have experienced these within the past year
  • Already in a psychological therapy/intervention
  • Planning a change of psychotropic medication during the research project.
  • No access to video calling and/or slow internet connection speed
  • A mental health condition that is not currently well managed/stable and therefore other interventions are likely to be more appropriate
  • Does not own a smartphone that can record screen time
  • Is not living in the UK, with access to services within the UK

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Problematic smart phone use course
Behavioral: Problematic smart phone use course
A 6 session, online, group-based, psychological course targetting problematic smart phone use.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from pre-intervention (week 1) at post-intervention (week 10) on the Smartphone Addiction Scale -Short Version (SAS-SV).
Time Frame: Post-intervention (week 10)
This measures smartphone addiction producing a score between 10 and 60, with higher scores indicating greater levels of addiction.
Post-intervention (week 10)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from pre-intervention (week 1) at follow-up (week 18) on the Smartphone Addiction Scale -Short Version (SAS-SV).
Time Frame: Follow-up (week 18)
This measures smartphone addiction producing a score between 10 and 60, with higher scores indicating greater levels of addiction.
Follow-up (week 18)
Change from pre-intervention (week 1) at post-intervention (week 10) on the Depression, Anxiety and Stress Scale -21 item version (DASS-21).
Time Frame: Post-intervention (week 10)
This measures levels of depression, anxiety and stress, producing a score between 0 for 42 each, with higher levels indicating greater severity.
Post-intervention (week 10)
Change from pre-intervention (week 1) at follow-up (week 18) on the Depression, Anxiety and Stress Scale -21 item version (DASS-21).
Time Frame: Follow-up (week 18)
This measures levels of depression, anxiety and stress, producing a score between 0 for 42 each, with higher levels indicating greater severity.
Follow-up (week 18)
Change from pre-intervention (week 1) at post-intervention (week 10) on the Multicultural Quality of Life Index.
Time Frame: Post-intervention (week 10)
This measures of quality of life, producing a score between 1 and 10, with higher scores indicating greater quality of life.
Post-intervention (week 10)
Change from pre-intervention (week 1) at follow-up (week 18) on the Multicultural Quality of Life Index.
Time Frame: Follow-up (week 18)
This measures of quality of life, producing a score between 1 and 10, with higher scores indicating greater quality of life.
Follow-up (week 18)
Change in daily subjective units of distress from the baseline period (weeks 0 and 1) to the intervention period (weeks 2 to 9)
Time Frame: Intervention period (weeks 2 to 9)
Single case analysis will compare daily subject units of distress ratings from the baseline period to the intervention period. Separate daily ratings, on a 0 to 100 scale, will be obtained for each of anxiety, stress, low mood, and tiredness, with higher ratings indicating higher levels.
Intervention period (weeks 2 to 9)
Change in daily subjective units of distress from the baseline period (weeks 0 and 1) to the follow-up period (weeks 17 to 18)
Time Frame: Follow-up period (weeks 17 to 18)
Single case analysis will compare daily subject units of distress ratings from the baseline period to the follow-up period. Separate daily ratings, on a 0 to 100 scale, will be obtained for each of anxiety, stress, low mood, and tiredness, with higher ratings indicating higher levels.
Follow-up period (weeks 17 to 18)
Change in daily phone use from the baseline period (weeks 0 and 1) to the intervention period (weeks 2 to 9)
Time Frame: Intervention period (weeks 2 to 9)
Single case analysis will compare daily phone use from the baseline period to the intervention period. Daily use will be measured by screentime (in minutes) and number of pick-ups.
Intervention period (weeks 2 to 9)
Change in daily phone use from the baseline period (weeks 0 and 1) to the follow-up period (weeks 17 to 18)
Time Frame: Follow-up period (weeks 17 to 18)
Single case analysis will compare daily phone use from the baseline period to the follow-up period. Daily use will be measured by screentime (in minutes) and number of pick-ups.
Follow-up period (weeks 17 to 18)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Qualitative interview
Time Frame: Week 18
In week 18, a qualitative interview will be conducted, based on Elliot's Change Interview. This will explore participants' experiences of the intervention and perceptions of related change.
Week 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Canterbury Christ Church University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brett Hayes, Canterbury Christ Church University
  • Study Director: Fergal Jones, Canterbury Christ Church University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2022

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020_Brett_Hayes_MRP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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