Behavior TherapyNCT02535598
Therapy Labs: To Improve Adherence in Internet Based Psychotherapy
A study testing Normal presentation, Enhanced presentation and Normal support in people with Behavior Therapy, run by Uppsala University at 1 site in Sweden.
Trial summary
This project aims to investigate factors that are important in affecting adherence in internet based Cognitive Behavior Therapy (CBT). It is hypothesized that two intervention-specific variables, Support and Content, are important factors and that maximizing the impact of these would result in improved adherence and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavior Therapy
- What is being tested?
- Normal presentation, Enhanced presentation and Normal support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteSweden
- Study dates
- May 2014to Sep 2015
- 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
- Self-reported mild to moderate symptoms of stress or worry
Who cannot join
- insufficient mastery of Swedish language
- elevated symptoms of anxiety or depression that warrant clinical care
- other medical or mental illness that need immediate clinical attention
- no daily access to computer, internet and cell phone
Trial locations and contacts
1 site in 1 country.
About this study
This project aims to investigate factors that are important in affecting adherence in internet based Cognitive Behavior Therapy (CBT). It is hypothesized that two intervention-specific variables, Support and Content, are important factors and that maximizing the impact of these would result in improved adherence and potentially in the end also better outcome for participants in internet interventions.
Read the detailed description
This study centers on people with mild symptoms of stress or worry. Participants are recruited by advertisement and the web. Potential participants are contacted by phone and informed about the study. Written informed consent is collected through mail from those who are interested in participating. They are asked to answer all the instruments of the study via a secure internet portal used for delivering the intervention. If they do not fulfill the exclusion criteria they are randomized to one of four conditions. When the intervention has ended participants are asked to fill out all the instruments and again at four week follow up. To find significant (p<.05) results on the primary outcome variables with estimated medium effect sizes, pair-wise comparisons, a power of .80 and allowing for 10% attrition, forty participants are needed in each condition.
The intervention used in this project will be a standard program of applied relaxation that has been used and empirically tested in previous clinical studies. Since the aim of the present project is to investigate factors that affect adherence rather than the intervention effect, the investigators will use a well tested intervention with known effects on symptoms of stress and anxiety. Previous studies have shown that self help with applied relaxation can have a positive effect on for example stress, anxiety and sleep. By providing an intervention that is beneficial, credible and relevant for people with mild symptoms of stress and anxiety it would be possible to investigate how manipulating different factors of the intervention affects the adherence. Applied relaxation will in this intervention consist of a four-week program provided via the Internet. The exact composition of the intervention will be slightly different in each condition depending on the research question, see below. The program includes four steps; tension sensitivity training, long relaxation, short relaxation and applied relaxation. Each week includes information, assignments and support via the secure internet portal.
- Conditions
- Behavior Therapy
- Being tested
- Normal presentation, Enhanced presentation, Normal support, Enhanced support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal presentationBehavioural
All the material will be presented as plain text.
Enhanced presentationBehavioural
The material of the intervention is designed to be as appealing as possible with clear organization, animated presentations, ample illustrations, etc.
Normal supportBehavioural
Participants receive semi-standardized support once a week and there will be no formal training or competence.
Enhanced supportBehavioural
Participants are offered daily support through the internet from trained therapists.
| Study group | Role | What they receive |
|---|---|---|
| Normal presentation | Active comparator | Standard internet based CBT presentation. Receives: Behavioral: Normal presentation |
| Enhanced presentation | Experimental | Enhanced internet CBT presentation. Receives: Behavioral: Enhanced presentation |
| Normal support | Active comparator | Standard internet based CBT support. Receives: Behavioral: Normal support |
| Enhanced support | Experimental | Enhanced internet CBT support. Receives: Behavioral: Enhanced support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment components completed
Measured: Four weeks after treatment start
Number of behavioral prescriptions completed
Measured: Four weeks after treatment start
Secondary outcomes (1)
Perceived Stress Scale
Measured: Baseline and four weeks after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionSep 2015
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 Behavior TherapyStudies 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timo Hursti, PhD, Study director, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535598
- Sponsor's protocol ID
- sveal1031
- Status last verified
- May 2016
- First submitted
- 3 Aug 2015
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Alfonsson S, Olsson E, Hursti T. Motivation and Treatment Credibility Predicts Dropout, Treatment Adherence, and Clinical Outcomes in an Internet-Based Cognitive Behavioral Relaxation Program: A Randomized Controlled Trial. J Med Internet Res. 2016 Mar 8;18(3):e52. doi: 10.2196/jmir.5352.
PubMed 26957354
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy Labs: To Improve Adherence in Internet Based Psychotherapy
- ClinicalTrials.gov ID
- NCT02535598
- Acronym / sponsor ID
- sveal1031
- Conditions
- Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 28 Aug 2015 (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.
This project aims to investigate factors that are important in affecting adherence in internet based Cognitive Behavior Therapy (CBT). It is hypothesized that two intervention-specific variables, Support and Content, are important factors and that maximizing the impact of these would result in improved adherence and potentially in the end also better outcome for participants in internet interventions.
Detailed description
This study centers on people with mild symptoms of stress or worry. Participants are recruited by advertisement and the web. Potential participants are contacted by phone and informed about the study. Written informed consent is collected through mail from those who are interested in participating. They are asked to answer all the instruments of the study via a secure internet portal used for delivering the intervention. If they do not fulfill the exclusion criteria they are randomized to one of four conditions. When the intervention has ended participants are asked to fill out all the instruments and again at four week follow up. To find significant (p<.05) results on the primary outcome variables with estimated medium effect sizes, pair-wise comparisons, a power of .80 and allowing for 10% attrition, forty participants are needed in each condition.
The intervention used in this project will be a standard program of applied relaxation that has been used and empirically tested in previous clinical studies. Since the aim of the present project is to investigate factors that affect adherence rather than the intervention effect, the investigators will use a well tested intervention with known effects on symptoms of stress and anxiety. Previous studies have shown that self help with applied relaxation can have a positive effect on for example stress, anxiety and sleep. By providing an intervention that is beneficial, credible and relevant for people with mild symptoms of stress and anxiety it would be possible to investigate how manipulating different factors of the intervention affects the adherence. Applied relaxation will in this intervention consist of a four-week program provided via the Internet. The exact composition of the intervention will be slightly different in each condition depending on the research question, see below. The program includes four steps; tension sensitivity training, long relaxation, short relaxation and applied relaxation. Each week includes information, assignments and support via the secure internet portal.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal presentation | Active comparator | Behavioral: Normal presentationStandard internet based CBT presentation. |
| Enhanced presentation | Experimental | Behavioral: Enhanced presentationEnhanced internet CBT presentation. |
| Normal support | Active comparator | Behavioral: Normal supportStandard internet based CBT support. |
| Enhanced support | Experimental | Behavioral: Enhanced supportEnhanced internet CBT support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self-reported mild to moderate symptoms of stress or worry
Key exclusion criteria (4 listed)
- insufficient mastery of Swedish language
- elevated symptoms of anxiety or depression that warrant clinical care
- other medical or mental illness that need immediate clinical attention
- no daily access to computer, internet and cell phone
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 |
|---|---|---|
| Normal presentationAll the material will be presented as plain text. | Behavioural | Normal presentation |
| Enhanced presentationThe material of the intervention is designed to be as appealing as possible with clear organization, animated presentations, ample illustrations, etc. | Behavioural | Enhanced presentation |
| Normal supportParticipants receive semi-standardized support once a week and there will be no formal training or competence. | Behavioural | Normal support |
| Enhanced supportParticipants are offered daily support through the internet from trained therapists. | Behavioural | Enhanced support |
Primary outcome
Number of treatment components completed
Time frame: Four weeks after treatment start
Number of behavioral prescriptions completed
Time frame: Four weeks after treatment start
1 secondary outcome
Perceived Stress Scale
Time frame: Baseline and four weeks after treatment start
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 May 2016.
- Derived from this study: PubMed 26957354Alfonsson S, Olsson E, Hursti T. Motivation and Treatment Credibility Predicts Dropout, Treatment Adherence, and Clinical Outcomes in an Internet-Based Cognitive Behavioral Relaxation Program: A Randomized Controlled Trial. J Med Internet Res. 2016 Mar 8;18(3):e52. doi: 10.2196/jmir.5352.
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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.
Timo Hursti, PhD 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 Normal presentation, Enhanced presentation and Normal support in people with Behavior Therapy, 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 4 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 May 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?
Number of treatment components completed (time frame: Four weeks after treatment start). The study lists 2 primary outcomes in all. 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 NCT02535598, 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 May 2016.