Clinical trial NCT01819025: Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support
Official title: Face-to-face CBT Treatment of Depression With Smartphone Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Behavioral activation
Smartphone application
Face-to-face
Blended therapy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2013-03-27
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* depressive symptoms according to DSM-IV
* have access to a smartphone and to the Internet
* have good knowledge of the Swedish language

Exclusion Criteria:

* recent (during last 6 weeks) change in psychiatric medication
* presently in any other psychological treatment
* severe depression
* suicidal ideation

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)- Change from baseline
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
measure: Beck Depression Inventory (BDI)- Change from baseline
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Secondary outcomes:
measure: Quality of Life Inventory (QOLI)- Change from baseline
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
measure: Acceptance & Action Questionnaire (AAQ)- Change from baseline
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
measure: Beck Anxiety Inventory (BAI)- Change from baseline
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
measure: Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)- Change from baseline
timeFrame: Two weeks pre treatment and at six months post treatment.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
state: Östergötland
Study officials:
References:
citation: 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.