Behavioural Activation-Based Treatment Administered Through Smartphone
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Depression |
Behavioral: Smartphone delivered BA Other: Smartphone delivered mindfulness |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Behavioural Activation-Based Guided Self-Help Treatment Administered Through a Smartphone Application |
- 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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
- 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 ] [ Designated as safety issue: No ]Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 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 ] [ Designated as safety issue: No ]Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 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 ] [ Designated as safety issue: No ]Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 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. ] [ Designated as safety issue: No ]Change from baseline in health cost burden and at six months post treatment.
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Smartphone delivered BA |
Behavioral: Smartphone delivered BA
A 8 week behavioural activation therapy delivered through smartphone
|
| Active Comparator: Smartphone delivered mindfulness |
Other: Smartphone delivered mindfulness
A 8 week mindfulness intervention delivered through smartphone
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- depressive symptoms according to DSM-IV
- have access to the Internet and a smartphone
- 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
Contacts and Locations More Information
No publications provided by Linkoeping University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gerhard Andersson, Professor, Linkoeping University |
| ClinicalTrials.gov Identifier: | NCT01463020 History of Changes |
| Other Study ID Numbers: | GA-PC-KHL |
| Study First Received: | October 28, 2011 |
| Last Updated: | March 22, 2013 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Linkoeping University:
|
Depression Smartphone Behavioural activation Mindfulness |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013