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NCT Number: NCT04277793

Feasibility Evaluation of a Monitored Self-guided Cognitive Behavioural Therapy Digital Format

The purpose of the study is to evaluate the feasibility of a new monitored self-guided digital cognitive behavioural therapy format through one of the key components of an intervention for depression and anxiety (Problem Solving) and to answer the question: Do patients with significant levels of depression and/or anxiety symptoms consider the monitored self-guided digital format usable and credible? An uncontrolled trial will explore participant's usability and treatment credibility ratings.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centrum för Psykiatriforskning

Stockholm, Sweden

About this study

Objective. The purpose of the study is to evaluate the feasibility of a new monitored self-guided digital cognitive behavioural therapy format through one of the key components of an intervention for depression and anxiety (Problem Solving) and to answer the question: Do patients with significant levels of depression and/or anxiety symptoms consider the monitored self-guided digital format usable and credible?

Background. Problem Solving is a behavioral modification intervention focusing on the training of adaptive problem-solving skills in order to cope more effectively with everyday stressful events. It is one of the most well-examined therapeutic interventions for depression, with reliable support regarding symptom improvement in depression traditionally delivered with therapist-guidance when administered via the Internet. Since a new monitored self-guided digital intervention for depression and anxiety has been developed, including the key component Problem Solving, it is of importance to assess both the usability and treatment-credibility of this format to evaluate if it is feasible.

Methodology. Based on similar feasibility studies including around ten participants, a number of 16-30 participants will be included in this study to compensate for potential drop-outs. Participants will be recruited via a psychiatric clinic belonging to Stockholm County Council in Stockholm, Sweden, and will be patients in queue for treatment for depression and/or anxiety in a psychiatric setting. Inclusion criteria will be significant depression and/or anxiety symptoms. The participants included in the study will access the key component Problem Solving during four weeks while being on waitlist for regular treatment. They will be introduced to the intervention as a self-explanatory tool with possible beneficial effects on depression symptoms. Self-assessments will be carried out during the intervention. The scores on these scales will be compared to available published data from these scales from evaluations of therapist-guided Internet-based interventions if available, and otherwise data from these scales from studies on other digital interventions for mental health. The participants will also answer questions concerning their experience of the format.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Significant depression and/or anxiety symptoms measured with Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder (GAD-7) (i.e. a PHQ-9 and/or GAD-7 score of ≥5).

Exclusion criteria

  • insufficient Swedish knowledge
  • minor (i.e. age <18 years)
  • high suicide risk (i.e. a score ≥4 on the ninth item on the Montgomery Åsberg Depression Scale, MADRS-S)
  • lack of access to a device with Internet connection (e.g. computer, mobile, tablet)
  • lack of access to a phone on which calls and SMS can be received
  • psychiatric or somatic problems that must be prioritized before or become an excessive obstacle to the intervention.

Treatment and study plan

Monitored self-guided problem solving

Behavioral

Problem Solving is a behavioral modification intervention focusing on the training of adaptive problem-solving skills in order to cope more effectively with everyday stressful events.

Primary outcomes

  1. System Usability Scale

    Time frame: immediately after the intervention

    Self-rated assessment of usability, higher score is better

  2. Treatment Credibility Scale

    Time frame: immediately after the intervention

    Self-rated assessment of treatment credibility, higher score is better

Secondary outcomes

  1. Negative Effects Questionnaire

    Time frame: immediately after the intervention

    Self-rated assessment of negative treatment effects, lower score is better

  2. Negative Effects Questionnaire

    Time frame: During the intervention: 2 weeks from baseline

    Self-rated assessment of negative treatment effects, lower score is better

  3. Patient Health Questionnaire - 9

    Time frame: Change from baseline immediately after the intervention

    Self-rated depressive symptoms, lower score is better

  4. Generalized Anxiety Disorder - 7

    Time frame: Change from baseline immediately after the intervention

    Self-rated anxiety symptoms, lower score is better

  5. System Usability Scale

    Time frame: During the intervention: 2 weeks from baseline

    Self-rated assessment of usability, higher score is better

  6. Treatment Credibility Scale

    Time frame: During the intervention: 2 weeks from baseline

    Self-rated assessment of treatment credibility, higher score is better

Other outcomes

  1. Evaluation of treatment format

    Time frame: During the intervention: 2 weeks from baseline

    Written quantitative and qualitative questions concerning the treatment format

  2. Evaluation of treatment format

    Time frame: immediately after the intervention

    Written quantitative and qualitative questions concerning the treatment format

  3. Interview concerning treatment format

    Time frame: immediately after the intervention

    Phone interview with qualitative questions concerning the treatment format

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Feasibility Evaluation of a Monitored Self-guided Digital Cognitive Behavioural Therapy Format: an Uncontrolled Trial of a Problem Solving Intervention for Depression and Anxiety

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 20, 2020
Registry last updated
Dec 14, 2020

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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