DepressionNCT01819025
Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support
A study testing 4 face-to-face therapy session and a smartphone-app and CBT, treatment as usual in people with Depression, run by Linkoeping University at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate whether face-to-face Cognitive Behavioral Therapy (CBT) with a smartphone application, focused on providing support in homework assignments and an increase in behavioral activation, is effective in treating mild to moderate depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- 4 face-to-face therapy session and a smartphone-app and CBT, treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2013to Jan 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- depressive symptoms according to DSM-IV
- have access to a smartphone and to the Internet
- 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: Face-to-face CBT Treatment of Depression With Smartphone Support
The purpose of this study is to investigate whether face-to-face Cognitive Behavioral Therapy (CBT) with a smartphone application, focused on providing support in homework assignments and an increase in behavioral activation, is effective in treating mild to moderate depression. The study will be conducted as a randomized controlled treatment study investigating the effect of the current blended treatment compared to treatment as usual.
Read the detailed description
Mild to moderate depression is a major health problem, which lowers the quality of life for the individual and generates enormous costs for society. Several forms of psychotherapy have been found to be effective in the treatment of depression. Among these, behavioral activation has a strong empirical base. The efficacy of behavioral activation for treating major depressive disorders has been established in a number of studies over the last four decades.
Moreover face-to-face treatments could benefit from using smartphones as an adjunct to the regular sessions, which in the case of behavioral activation treatments for depression could facilitate activity scheduling and homework, which are crucial elements of the treatment. It may also be possible to reduce the number of sessions.
Since it has been shown that full behavioral activation is an effective treatment for mild to moderate depression, this study will be designed as a so-called non-inferiority study in which the treatment group, given fewer meetings face-to-face, but instead support in the form of a smartphone application. Instead of a traditional behavioral activation treatment of 10 sessions, the treatment group will be given four face-to-face CBT sessions and a smartphone app as a complement and support to the four sessions. As a control, the investigators will give full behavioral activation with 10 sessions of face-to-face therapy.
- Conditions
- Depression
- Being tested
- 4 face-to-face therapy session and a smartphone-app, CBT, treatment as usual
- Keywords
- Depression, Behavioral activation, Smartphone application, Face-to-face, Blended therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 face-to-face therapy session and a smartphone-appBehavioural
An 8 week blended therapy with both face-to-face therapy sessions and support through a smartphone application.
CBT, treatment as usualBehavioural
10 sessions of face-to-face therapy, full behavioral activation
| Study group | Role | What they receive |
|---|---|---|
| 4 face-to-face and smartphone-app | Experimental | Four face-to-face therapy sessions and smartphone app as a complement and support to the four sessions. Receives: Behavioral: 4 face-to-face therapy session and a smartphone-app |
| TAU | Active comparator | 10 sessions of face-to-face therapy, full behavioral activation Receives: Behavioral: CBT, treatment as usual |
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 posted27 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completionJan 2014
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 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819025
- Sponsor's protocol ID
- GA-PC-HH-KHL
- Status last verified
- Jul 2013
- First submitted
- 22 Mar 2013
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ly KH, Topooco N, Cederlund H, Wallin A, Bergstrom J, Molander O, Carlbring P, Andersson G. Smartphone-Supported versus Full Behavioural Activation for Depression: A Randomised Controlled Trial. PLoS One. 2015 May 26;10(5):e0126559. doi: 10.1371/journal.pone.0126559. eCollection 2015.
PubMed 26010890
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Face-to-face CBT Treatment of Depression With Smartphone Support
- ClinicalTrials.gov ID
- NCT01819025
- Acronym / sponsor ID
- GA-PC-HH-KHL
- Conditions
- Depression
- Keywords
- Depression, Behavioral activation, Smartphone application, Face-to-face, Blended therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Mar 2013 (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 purpose of this study is to investigate whether face-to-face Cognitive Behavioral Therapy (CBT) with a smartphone application, focused on providing support in homework assignments and an increase in behavioral activation, is effective in treating mild to moderate depression. The study will be conducted as a randomized controlled treatment study investigating the effect of the current blended treatment compared to treatment as usual.
Detailed description
Mild to moderate depression is a major health problem, which lowers the quality of life for the individual and generates enormous costs for society. Several forms of psychotherapy have been found to be effective in the treatment of depression. Among these, behavioral activation has a strong empirical base. The efficacy of behavioral activation for treating major depressive disorders has been established in a number of studies over the last four decades.
Moreover face-to-face treatments could benefit from using smartphones as an adjunct to the regular sessions, which in the case of behavioral activation treatments for depression could facilitate activity scheduling and homework, which are crucial elements of the treatment. It may also be possible to reduce the number of sessions.
Since it has been shown that full behavioral activation is an effective treatment for mild to moderate depression, this study will be designed as a so-called non-inferiority study in which the treatment group, given fewer meetings face-to-face, but instead support in the form of a smartphone application. Instead of a traditional behavioral activation treatment of 10 sessions, the treatment group will be given four face-to-face CBT sessions and a smartphone app as a complement and support to the four sessions. As a control, the investigators will give full behavioral activation with 10 sessions of face-to-face therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 face-to-face and smartphone-app | Experimental | Behavioral: 4 face-to-face therapy session and a smartphone-appFour face-to-face therapy sessions and smartphone app as a complement and support to the four sessions. |
| TAU | Active comparator | Behavioral: CBT, treatment as usual10 sessions of face-to-face therapy, full behavioral activation |
Who may qualify
- Ages
- 18 years and older
- 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 a smartphone and to the Internet
- 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 |
|---|---|---|
| 4 face-to-face therapy session and a smartphone-appAn 8 week blended therapy with both face-to-face therapy sessions and support through a smartphone application. | Behavioural | 4 face-to-face and smartphone-app |
| CBT, treatment as usual10 sessions of face-to-face therapy, full behavioral activation | Behavioural | TAU |
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 7 Feb 2014.
- Derived from this study: PubMed 26010890Ly KH, Topooco N, Cederlund H, Wallin A, Bergstrom J, Molander O, Carlbring P, Andersson G. Smartphone-Supported versus Full Behavioural Activation for Depression: A Randomised Controlled Trial. PLoS One. 2015 May 26;10(5):e0126559. doi: 10.1371/journal.pone.0126559. eCollection 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 face-to-face therapy session and a smartphone-app and CBT, treatment as usual 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 7 Feb 2014. 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 NCT01819025, 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 7 Feb 2014.