The (cost-) effectiveness of blended Cognitive Behavioral Therapy (bCBT) for Major Depressive Disorder in specialised mental health care: E-COMPARED trial in the Netherlands.

The (cost-) effectiveness of blended Cognitive Behavioral Therapy (bCBT) for Major Depressive Disorder in specialised mental health care: E-COMPARED trial in the Netherlands. - Blended CBT for depression in specialised mental health care

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44347

Enrollment

150

Registered

2016-08-25

Start date

2015-07-29

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression mood disorder

Interventions

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 e

blended CBT

ecological momentary assessment

major depressive disorder (MDD)

specialised mental healthcare

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Primary study outcome is the score on the PHQ-9/QIDS-SR, measuring the level of depressive symptoms.	—

Secondary

Measure	Time frame
- 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)	—

Measure

Time frame

- 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)

—

Countries

France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)