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Completed

NCT Number: NCT04428450

Internet-Based Treatment of Depression: Comparing Guided With Unguided Self-Help

The study is a randomized controlled trial and to compare the benefits of a 10-week web-based unguided self-help treatment with the same intervention complemented with weekly therapist support via e-mail. A waiting-list control group will be included. The Beck Depression Inventory (BDI-II) will be used as the primary outcome measure. Secondary outcomes include general psychopathology, interpersonal problems, and quality of life.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Depression is a major health problem associated with significant disability and economic costs. Although depression can be treated effectively with several psychological and pharmacological treatment options, many sufferers still seek or receive inadequate therapy or no therapy at all. Internet-based treatments may help to serve this demand, being accessible anytime and anywhere making it easier for underserved populations and people living in remote areas to receive treatment. The present study aims to assess the efficacy of an internet-based CBT intervention for depression (Deprexis), directly comparing the benefits of a low intensity therapist-guided with an unguided self-help version. A waiting-list control group will be included. Individuals meeting the diagnostic criteria of major depression or dysthymia will be randomly assigned to one of the three conditions. While unguided self-help will not include any contact with a therapist or the study team during the treatment, guided self-help will include a weekly scheduled e-mail feedback by a therapist and the possibility to ask questions via e-mail. While in an earlier study Deprexis was assessed as an add-on to TAU, this study will examine the efficacy of the program when delivered as a stand-alone intervention (i.e., only individuals who currently do not receive psychotherapy will be included). Moreover, this study will include a structured diagnostic interview at pretreatment. Only participants fulfilling the criteria of a depressive disorder (major depression or dysthymia) will be included in the trial. Participants will be recruited in Switzerland and Germany via articles in national and regional newspapers and a national television interview. All questionnaires will be administered via the internet. The 21-item BDI-II will be used as the main outcome measure. Secondary outcome measures will include the Brief Symptom Inventory (53-item BSI), the Inventory of Interpersonal Problems (64-item IIP), and the WHOQOL-BREF.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • access to the internet
  • informed consent to participate
  • BDI-II score > 13
  • if prescribed, constant dosage of medication (depression/anxiety) for 1 month prior and during study

Exclusion criteria

  • suicide item of BDI ≥ 2
  • other psychological treatment during this study

Treatment and study plan

Deprexis

Device

CBT-based, integrative online self-help program

Primary outcomes

  1. Beck Depression Inventory - II (BDI-II)

    Time frame: 10 weeks

    Self-report questionnaire, depression symptom severity, scores can range from 0 to 63, with higher scores indicating more severe depression.

Secondary outcomes

  1. Brief Symptom Inventory (53-item BSI)

    Time frame: 10 weeks

    Psychopathology severity self-report measure; minimum value = 0, maximum value = 4 (higher scores indicate more severe psychopathology).

  2. Inventory of Interpersonal Problems (IIP)

    Time frame: 10 weeks

    Self-report measure of interpersonal problems; total score computed as the mean across all items; minimum value = 0, maximum value = 4 (higher scores indicate more severe psychopathology)

  3. WHOQOL-BREF

    Time frame: 10 weeks

    Self-report quality of life measure; scores can range from 0 to 100, with higher scores indicating better quality of life.

Other outcomes

  1. CSQ-8 (Client Satisfaction Questionnaire)

    Time frame: 10 weeks

    Self-report measure of global client satisfaction; scores can range from 1 to 4, with higher scores indicating greater satisfaction.

Sponsors and collaborators

Lead sponsor

Gaia AG

Industry

Collaborators

  • Karolinska Institutet
  • Linkoeping University
  • University of Bern

Registry information

Official study title

Internet-Based Treatment of Depression: A Randomized Controlled Trial Comparing Guided With Unguided Self-Help

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 11, 2020
Registry last updated
Feb 23, 2024

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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