DepressionNCT01463020
Behavioural Activation-Based Treatment Administered Through Smartphone
A study testing Smartphone delivered BA and Smartphone delivered mindfulness in people with Depression, run by Linkoeping University at 1 site in Sweden.
Trial summary
The objective is to test the effects of a smartphone-delivered behavioural activation treatment. Also, a moderator analysis of low and high severity of depressive symptoms will be made. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Smartphone delivered BA and Smartphone delivered mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2012to May 2013
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- depressive symptoms according to DSM-IV
- have access to the Internet and a smartphone
- have good knowledge of the Swedish language
Who cannot join
- recent (during last 6 weeks) change in psychiatric medication
- presently in any other psychological treatment
- severe depression
- suicidal ideation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioural Activation-Based Guided Self-Help Treatment Administered Through a Smartphone Application
The objective is to test the effects of a smartphone-delivered behavioural activation treatment. Also, a moderator analysis of low and high severity of depressive symptoms will be made. We expect the behavioural activation intervention to be superior to the mindfulness intervention for the participants suffering from high severity of depressive symptoms - and the mindfulness intervention to be better or at least as good as the behavioural activation intervention for the participants suffering from low severity of depressive symptoms.
Read the detailed description
Major depression is expected to be the disorder with the highest disease burden in high-income countries by the year 2030. The efficacy of behavioural activation in the treatment of major depressive disorders has been established in a number of studies over the last four decades. Furthermore, behavioural activation is an intervention that can largely benefit from the use of new mobile technologies (e.g. smartphones). One important feature of mobile technology is the possibility for the therapist to reach the patient between sessions and thus create direct incentives for behavioural activation in everyday life. Therefore, developing smartphone-based behavioural activation interventions might be a way to develop a cost-effective treatment for people suffering from major depressive disorders.
- Conditions
- Depression
- Being tested
- Smartphone delivered BA, Smartphone delivered mindfulness
- Keywords
- Depression, Smartphone, Behavioural activation, Mindfulness
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone delivered BABehavioural
A 8 week behavioural activation therapy delivered through smartphone
Smartphone delivered mindfulnessOther
A 8 week mindfulness intervention delivered through smartphone
| Study group | Role | What they receive |
|---|---|---|
| Smartphone delivered BA | Experimental | Not described Receives: Behavioral: Smartphone delivered BA |
| Smartphone delivered mindfulness | Active comparator | Not described Receives: Other: Smartphone delivered mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9)- Change from baseline
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Measured: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Beck Depression Inventory (BDI)- Change from baseline
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Measured: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Secondary outcomes (4)
Quality of Life Inventory (QOLI)- Change from baseline
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Measured: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Acceptance & Action Questionnaire (AAQ)- Change from baseline
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Measured: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Beck Anxiety Inventory (BAI)- Change from baseline
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Measured: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)- Change from baseline
Change from baseline in health cost burden and at six months post treatment.
Measured: Two weeks pre treatment and at six months post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startFeb 2012
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Linkoeping 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, Professor, Study director, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463020
- Sponsor's protocol ID
- GA-PC-KHL
- Status last verified
- Jun 2013
- First submitted
- 28 Oct 2011
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ly KH, Truschel A, Jarl L, Magnusson S, Windahl T, Johansson R, Carlbring P, Andersson G. Behavioural activation versus mindfulness-based guided self-help treatment administered through a smartphone application: a randomised controlled trial. BMJ Open. 2014 Jan 9;4(1):e003440. doi: 10.1136/bmjopen-2013-003440.
PubMed 24413342Ly KH, Carlbring P, Andersson G. Behavioral activation-based guided self-help treatment administered through a smartphone application: study protocol for a randomized controlled trial. Trials. 2012 May 18;13:62. doi: 10.1186/1745-6215-13-62.
PubMed 22607302
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Activation-Based Guided Self-Help Treatment Administered Through a Smartphone Application
- ClinicalTrials.gov ID
- NCT01463020
- Acronym / sponsor ID
- GA-PC-KHL
- Conditions
- Depression
- Keywords
- Depression, Smartphone, Behavioural activation, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Feb 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 1 Nov 2011 (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 objective is to test the effects of a smartphone-delivered behavioural activation treatment. Also, a moderator analysis of low and high severity of depressive symptoms will be made. We expect the behavioural activation intervention to be superior to the mindfulness intervention for the participants suffering from high severity of depressive symptoms - and the mindfulness intervention to be better or at least as good as the behavioural activation intervention for the participants suffering from low severity of depressive symptoms.
Detailed description
Major depression is expected to be the disorder with the highest disease burden in high-income countries by the year 2030. The efficacy of behavioural activation in the treatment of major depressive disorders has been established in a number of studies over the last four decades. Furthermore, behavioural activation is an intervention that can largely benefit from the use of new mobile technologies (e.g. smartphones). One important feature of mobile technology is the possibility for the therapist to reach the patient between sessions and thus create direct incentives for behavioural activation in everyday life. Therefore, developing smartphone-based behavioural activation interventions might be a way to develop a cost-effective treatment for people suffering from major depressive disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone delivered BA | Experimental | Behavioral: Smartphone delivered BA |
| Smartphone delivered mindfulness | Active comparator | Other: Smartphone delivered mindfulness |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- depressive symptoms according to DSM-IV
- have access to the Internet and a smartphone
- have good knowledge of the Swedish language
Key exclusion criteria (4 listed)
- recent (during last 6 weeks) change in psychiatric medication
- presently in any other psychological treatment
- severe depression
- suicidal ideation
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 |
|---|---|---|
| Smartphone delivered BAA 8 week behavioural activation therapy delivered through smartphone | Behavioural | Smartphone delivered BA |
| Smartphone delivered mindfulnessA 8 week mindfulness intervention delivered through smartphone | Other | Smartphone delivered mindfulness |
Primary outcome
Patient Health Questionnaire (PHQ-9)- Change from baseline
Time frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Beck Depression Inventory (BDI)- Change from baseline
Time frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
4 secondary outcomes
Quality of Life Inventory (QOLI)- Change from baseline
Time frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Acceptance & Action Questionnaire (AAQ)- Change from baseline
Time frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Beck Anxiety Inventory (BAI)- Change from baseline
Time frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)- Change from baseline
Time frame: Two weeks pre treatment and at six months post treatment.
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 19 Jun 2013.
- Derived from this study: PubMed 24413342Ly KH, Truschel A, Jarl L, Magnusson S, Windahl T, Johansson R, Carlbring P, Andersson G. Behavioural activation versus mindfulness-based guided self-help treatment administered through a smartphone application: a randomised controlled trial. BMJ Open. 2014 Jan 9;4(1):e003440. doi: 10.1136/bmjopen-2013-003440.
- Derived from this study: PubMed 22607302Ly KH, Carlbring P, Andersson G. Behavioral activation-based guided self-help treatment administered through a smartphone application: study protocol for a randomized controlled trial. Trials. 2012 May 18;13:62. doi: 10.1186/1745-6215-13-62.
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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.
Gerhard Andersson, Professor study director
Linkoeping 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 Smartphone delivered BA and Smartphone delivered mindfulness in people with Depression, run by Linkoeping 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 3 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 19 Jun 2013. 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?
Patient Health Questionnaire (PHQ-9)- Change from baseline (time frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment). 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 NCT01463020, which also lists 2 linked publications.
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 19 Jun 2013.