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Completed

NCT Number: NCT02449447

Blended Depression Therapy: Cognitive Behaviour Therapy Face-to-face and Via Internet

To asses the clinical effectiveness of blended cognitive behavior therapy (CBT): face-to-face and internet-based treatment for adults with Major Depressive Disorder (MDD) in primary care compared to treatment as usual.

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Key information

Conditions

Major Depressive Disorders Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

About this study

The study is part of a EU-project. Participants are recruited via regular routes from primary care settings. Following the Mini International Neuropsychiatric Interview (M.I.N.I.) participants will be randomly allocated to either blended treatment for 10 sessions/weeks or to treatment as usual. We will include 150 participants in total.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • depressive symptoms according to DSM-IV
  • have access to a computer with internet connection
  • 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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

CBT based on behavioral activation and cognitive therapy techniques including homework

Treatment as Usual

Other

Treatment as usual in primary care including antidepressants and counselling

Primary outcomes

  1. Quick Inventory of Depressive Symptomatology Self-Report (QIDS

    Time frame: Change from baseline in symptoms of depression. Time Frame: 0, 3, 6 and 12 months

    Symptoms of depression measured by the QIDS. The QIDS is a questionnaire that screens for depressive symptoms and assesses depression severity.

Secondary outcomes

  1. EuroQol-5D (EQ-5D-5L)

    Time frame: Time Frame: 0, 3, 6 and 12 months

    Quality of life will be assessed with the EQ-5D-5L (EuroQol). The EQ-5D-5L is a self-report questionnaire which measures health related quality of life.

  2. Client Satisfaction Questionnaire (CSQ-8)

    Time frame: Time Frame: 3 months (post treatment)

    Patient's satisfaction with the treatment is assessed with Client Satisfaction Questionnaire (CSQ-8)

  3. Credibility and Expectancy Questionnaire (CEQ)

    Time frame: Time Frame: 3 months (post treatment)

    Patients' expectancy of treatment will be assessed with the credibility and expectancy questionnaire (CEQ)

  4. System Usability Scale (SUS)

    Time frame: Time Frame: 3 months (post treatment)

    Satisfaction with the internet platform will be evaluated with the system usability scale (SUS)

  5. Patient Health Questionnaire (PHQ-9)

    Time frame: Time Frame: 0, 3, 6 and 12 months

    The PHQ-9 is a nine-item mood module that can be used to screen and to diagnose patients with depressive disorders.

  6. Working Alliance Inventory (WAI-SF)

    Time frame: Time Frame: 0 months ( three weeks after started treatment)

    The therapeutic alliance between therapists and patient will be assessed with the short version of the Working Alliance Inventory (WAI-SF).

  7. Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)

    Time frame: Time Frame: 0, 3, 6 and 12 months

    Health service uptake and production loss due to illness will be measured with the Trimbos and iMTA Questionnaires on Costs Associated with Psychiatric Illness (TiC-P)

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • European Commission

Registry information

Official study title

European Comparative Effectiveness Research on Internet-based Depression in Sweden (E-compared) Treatment). A Randomized Controlled Trial Comparing Blended Internet and Face-to-face CBT Against Treatment as Usual

Acronym: E-compared

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 20, 2015
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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