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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Depressive Symptoms, Anxiety

Intervention / Treatment
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* Behavioral: Monitored self-guided problem solving


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitored self-guided problem solving intervention<br>Monitored self-guided problem solving intervention | Behavioral: Monitored self-guided problem solving<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usability Scale | Self-rated assessment of usability, higher score is better | immediately after the intervention | 
| Treatment Credibility Scale | Self-rated assessment of treatment credibility, higher score is better | immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative Effects Questionnaire | Self-rated assessment of negative treatment effects, lower score is better | immediately after the intervention | 
| Negative Effects Questionnaire | Self-rated assessment of negative treatment effects, lower score is better | During the intervention: 2 weeks from baseline | 
| Patient Health Questionnaire - 9 | Self-rated depressive symptoms, lower score is better | Change from baseline immediately after the intervention | 
| Generalized Anxiety Disorder - 7 | Self-rated anxiety symptoms, lower score is better | Change from baseline immediately after the intervention | 
| System Usability Scale | Self-rated assessment of usability, higher score is better | During the intervention: 2 weeks from baseline | 
| Treatment Credibility Scale | Self-rated assessment of treatment credibility, higher score is better | During the intervention: 2 weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, Digital, Internet-based, Depression, Anxiety, Self-guided, Problem Solving, ICBT