Behavioral ProblemsAIDAIINCT02895308
Motivation and Adherence to Psychotherapy Assignments
A study testing Online psychoeducation and Face-to-face psychoeducation in people with Behavioral Problems, run by Uppsala University at 1 site in Sweden.
Trial summary
The aims of this study are to experimentally investigate and compare whether motivation variables can predict adherence to a prescribed assignment in face-to-face and online interventions using a psychotherapy analogue model. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavioral Problems
- What is being tested?
- Online psychoeducation and Face-to-face psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2015to 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having at least one problematic behavior one wished to understand or change
Who cannot join
- being below 18 years of age, having no access to a mobile phone and the Internet, reporting elevated levels of depressive symptoms or currently attending psychotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in Motivation and Adherence to a Prescribed Assignment After Face-to-face and Online Psychoeducation: an Experimental Study
The aims of this study are to experimentally investigate and compare whether motivation variables can predict adherence to a prescribed assignment in face-to-face and online interventions using a psychotherapy analogue model.
A total of 100 participants are included in this study and randomized to either a face-to-face or online intervention. Participants in both groups receive a psychoeducation session and are given an assignment for the subsequent week.
Read the detailed description
The aims of this study are to investigate (1) participants' different forms of motivations to complete a typical psychotherapy assignment, (2) participants' subsequent adherence to the prescribed assignment and the associations between motivations and adherence and (3) any differences regarding motivations, adherence and their associations between the face-to-face and online conditions.
The hypotheses are that participants in the face-to-face condition will report higher motivation as well as higher adherence to the assignments compared to participants in the online condition, that adherence to the assignment will be positively associated with both autonomous motivation and externally regulated motivation and that adherence to the assignment will be more weakly associated with autonomous motivation in the face-to-face compared to the online condition.
To investigate the association between motivation and adherence to assignments in face-to-face and online settings, this study have a longitudinal randomized design with two conditions. The two conditions are face-to-face psychoeducation with a therapist and online psychoeducation with therapist support. A psychotherapy analogue model with a one-session intervention for a non-clinical population is used. Data is collected at baseline and at seven to nine days follow-up.
- Conditions
- Behavioral Problems
- Being tested
- Online psychoeducation, Face-to-face psychoeducation
- Keywords
- compliance
- Medical subject headings
- Problem Behavior, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online psychoeducationBehavioural
The online intervention consists of a psychoeducation component taken from affect focused psychotherapy. In this model, emotions are physiological patterns that are shaped mainly in the context of previous relations. By using the model, patients are helped to better understand their current emotions, behaviors and cognitions. The aim of the intervention used in this study is to provide information about the six basic affects and how they may influence everyday behaviors and well-being in recurring patterns.
Face-to-face psychoeducationBehavioural
The intervention consists of a psychoeducation component taken from affect focused psychotherapy. In this model, emotions are physiological patterns that are shaped mainly in the context of previous relations. By using the model, patients are helped to better understand their current emotions, behaviors and cognitions. The aim of the intervention used in this study is to provide information about the six basic affects and how they may influence everyday behaviors and well-being in recurring patterns.
| Study group | Role | What they receive |
|---|---|---|
| Online | Experimental | The Online psychoeducation is presented on on a webpage. Receives: Behavioral: Online psychoeducation |
| Face-to-face | Active comparator | The face-to-face psychoeducation is provided by psychologist and psychology master students. Receives: Behavioral: Face-to-face psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to prescribed behavioral assignment
The number of prescribed assignments that each participant have completed.
Measured: Within 3 days after intervention end.
Secondary outcomes (2)
Situational Motivation Scale
The SIMS is a self-report measure developed based on the Self-determination theory to measure motivation in experimental tasks.
Measured: Within 3 days after intervention end.
VAS-scale regarding motivation
A Visual Analogue Scale (VAS) measuring homework motivation (scale: 0-100)
Measured: Within 3 days after intervention end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionNov 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavioral ProblemsStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise Essen, Professor, Study director, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895308
- Sponsor's protocol ID
- AIDA-II
- Acronym
- AIDAII
- Status last verified
- Sep 2016
- First submitted
- 30 Aug 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Alfonsson S, Johansson K, Uddling J, Hursti T. Differences in motivation and adherence to a prescribed assignment after face-to-face and online psychoeducation: an experimental study. BMC Psychol. 2017 Jan 26;5(1):3. doi: 10.1186/s40359-017-0172-5.
PubMed 28126022
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Motivation and Adherence to a Prescribed Assignment After Face-to-face and Online Psychoeducation: an Experimental Study
- ClinicalTrials.gov ID
- NCT02895308
- Acronym / sponsor ID
- AIDAII / AIDA-II
- Conditions
- Behavioral Problems
- Keywords
- compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 9 Sep 2016 (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.
The aims of this study are to experimentally investigate and compare whether motivation variables can predict adherence to a prescribed assignment in face-to-face and online interventions using a psychotherapy analogue model.
A total of 100 participants are included in this study and randomized to either a face-to-face or online intervention. Participants in both groups receive a psychoeducation session and are given an assignment for the subsequent week.
Detailed description
The aims of this study are to investigate (1) participants' different forms of motivations to complete a typical psychotherapy assignment, (2) participants' subsequent adherence to the prescribed assignment and the associations between motivations and adherence and (3) any differences regarding motivations, adherence and their associations between the face-to-face and online conditions.
The hypotheses are that participants in the face-to-face condition will report higher motivation as well as higher adherence to the assignments compared to participants in the online condition, that adherence to the assignment will be positively associated with both autonomous motivation and externally regulated motivation and that adherence to the assignment will be more weakly associated with autonomous motivation in the face-to-face compared to the online condition.
To investigate the association between motivation and adherence to assignments in face-to-face and online settings, this study have a longitudinal randomized design with two conditions. The two conditions are face-to-face psychoeducation with a therapist and online psychoeducation with therapist support. A psychotherapy analogue model with a one-session intervention for a non-clinical population is used. Data is collected at baseline and at seven to nine days follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online | Experimental | Behavioral: Online psychoeducationThe Online psychoeducation is presented on on a webpage. |
| Face-to-face | Active comparator | Behavioral: Face-to-face psychoeducationThe face-to-face psychoeducation is provided by psychologist and psychology master students. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- having at least one problematic behavior one wished to understand or change
Key exclusion criteria (1 listed)
- being below 18 years of age, having no access to a mobile phone and the Internet, reporting elevated levels of depressive symptoms or currently attending psychotherapy.
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 |
|---|---|---|
| Online psychoeducationThe online intervention consists of a psychoeducation component taken from affect focused psychotherapy. In this model, emotions are physiological patterns that are shaped mainly in the context of previous relations. By using the model, patients are helped to better understand their current emotions, behaviors and cognitions. The aim of the intervention used in this study is to provide information about the six basic affects and how they may influence everyday behaviors and well-being in recurring patterns. | Behavioural | Online |
| Face-to-face psychoeducationThe intervention consists of a psychoeducation component taken from affect focused psychotherapy. In this model, emotions are physiological patterns that are shaped mainly in the context of previous relations. By using the model, patients are helped to better understand their current emotions, behaviors and cognitions. The aim of the intervention used in this study is to provide information about the six basic affects and how they may influence everyday behaviors and well-being in recurring patterns. | Behavioural | Face-to-face |
Primary outcome
Adherence to prescribed behavioral assignment
Time frame: Within 3 days after intervention end.
The number of prescribed assignments that each participant have completed.
2 secondary outcomes
Situational Motivation Scale
Time frame: Within 3 days after intervention end.
VAS-scale regarding motivation
Time frame: Within 3 days after intervention end.
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 13 Sep 2016.
- Derived from this study: PubMed 28126022Alfonsson S, Johansson K, Uddling J, Hursti T. Differences in motivation and adherence to a prescribed assignment after face-to-face and online psychoeducation: an experimental study. BMC Psychol. 2017 Jan 26;5(1):3. doi: 10.1186/s40359-017-0172-5.
- 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.
Louise Essen, Professor study director
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online psychoeducation and Face-to-face psychoeducation in people with Behavioral Problems, run by Uppsala University at 1 site in Sweden.
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 13 Sep 2016. 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 Sweden. 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?
Adherence to prescribed behavioral assignment (time frame: Within 3 days after intervention end.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02895308, which also lists 1 linked publication.
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 13 Sep 2016.