Compare the clinical- and cost-effectiveness of blended cognitive behavioral treatment (bCBT) to treatment as usual (TAU) for adults with MDD in specialised ambulatory mental healthcare.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study outcome is the score on the PHQ-9/QIDS-SR, measuring the level of
depressive symptoms.
Secondary outcome
- A diagnosis of depression (and comorbid disorders), assessed with the MINI
International Neuropsychiatric Interview.
- Health-Related Quality of Life, measured with the EQ-5D-5L (EuroQol).
- Health service uptake and production loss due to illness, which produces
economic costs, measured with the Trimbos and iMTA Questionnaires on Costs
Associated with Psychiatric Illness (TiC-P).
- Patient's expectancy of treatment, measured with the Credibility and
Expectancy Questionnaire (CEQ)
- Patient*s satisfaction with the treatment, assessed with the Client
Satisfaction Questionnaire (CSQ-8)
- Satisfaction with the platform, evaluated with the System usability scale
(SUS)
- The working alliance between therapists and patient, assessed with the short
version of the Working Alliance Inventory (WAI-SF).
- The technical alliance, measured with the Technical Alliance Inventory (TAI)
- Patients' sense of mastery, measured with the Masteryscale
- Possible negative side-effect of the treatment, assessed with the 'Inventory
for the assessment of Negative Effects of Psychotherapy' (INEP)
Background summary
Internet-based CBT (iCBT) has been developed and shown effective for prevention
and treatment of depression in the general population and in primary care. The
next step is to find ways to deliver iCBT in routine mental health practice and
to test its effectiveness in that context. As patients in mental health care
have more severe and more complex symptomatology, it is assumed that so called
*blended* treatment (a combination of face-to-face and online treatment) is
most suitable for this population. Blended treatment may provide a (cost-)
effective alternative to face-to-face treatment for patients with major
depressive disorder (MDD).
Study objective
Compare the clinical- and cost-effectiveness of blended cognitive behavioral
treatment (bCBT) to treatment as usual (TAU) for adults with MDD in specialised
ambulatory mental healthcare.
Study design
A pragmatic randomized controlled trial (N = 150) with two parallel conditions,
comparing the clinical effects and economic outcomes of TAU (N = 75) to those
of bCBT (N = 75), as delivered in two treatment center locations of GGZ
inGeest. Measurements are taken at baseline (T0), at month 3 (T1) and
follow-up at month 6 (T2) and month 12 (T3).
Intervention
Blended cognitivive behavioral therapy (bCBT) combines individual face-to-face
CBT with CBT delivered through an Internet-based treatment platform
(ICT4Depression) and a mobile phone component for ecological momentary
assessment (EMA). Patients receive weekly alternating face-to-face and online
sessions over a period of 18 weeks. The core components of the treatment are:
(1) psycho-education, (2) cognitive restructuring, (3) behavioural activation
and (4) relapse prevention.
Study burden and risks
The burden consists of having to fill out extra questionnaires. The risk is
estimated to be low.
A.J. Ernststraat 1187
Amsterdam 1081 HL
NL
A.J. Ernststraat 1187
Amsterdam 1081 HL
NL
Listed location countries
Age
Inclusion criteria
- Being 18 years of age or older
- Meet DSM-IV diagnostic criteria for MDD as confirmed by the MINI International Neuropsychiatric Interview version 5.0 and a score > 5 on the PHQ-9.
Exclusion criteria
- Current high risk of suicide according to the MINI Interview section C.
- Serious psychiatric co-morbidity that requires alternative treatment including substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder as established at the MINI interview.
- Currently receiving psychological treatment for depression in primary or specialised mental health care.
- Being unable to comprehend the spoken and written Dutch language
- Not having access to a computer or tablet with an internet connection
- Not motivated to use the mobile application of the intervention that is offered on Android mobile phones (ICT4Depression)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50340.029.15 |