Centrum för Psykiatriforskning
Stockholm, Sweden
NCT Number: NCT04277793
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Stockholm, Sweden
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.
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
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.
Time frame: immediately after the intervention
Self-rated assessment of usability, higher score is better
Time frame: immediately after the intervention
Self-rated assessment of treatment credibility, higher score is better
Time frame: immediately after the intervention
Self-rated assessment of negative treatment effects, lower score is better
Time frame: During the intervention: 2 weeks from baseline
Self-rated assessment of negative treatment effects, lower score is better
Time frame: Change from baseline immediately after the intervention
Self-rated depressive symptoms, lower score is better
Time frame: Change from baseline immediately after the intervention
Self-rated anxiety symptoms, lower score is better
Time frame: During the intervention: 2 weeks from baseline
Self-rated assessment of usability, higher score is better
Time frame: During the intervention: 2 weeks from baseline
Self-rated assessment of treatment credibility, higher score is better
Time frame: During the intervention: 2 weeks from baseline
Written quantitative and qualitative questions concerning the treatment format
Time frame: immediately after the intervention
Written quantitative and qualitative questions concerning the treatment format
Time frame: immediately after the intervention
Phone interview with qualitative questions concerning the treatment format
Karolinska Institutet
Other
Feasibility Evaluation of a Monitored Self-guided Digital Cognitive Behavioural Therapy Format: an Uncontrolled Trial of a Problem Solving Intervention for Depression and Anxiety
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