Clinical trial NCT04277793: Feasibility Evaluation of a Monitored Self-guided Cognitive Behavioural Therapy Digital Format
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Anxiety
Keywords: CBT
Digital
Internet-based
Depression
Anxiety
Self-guided
Problem Solving
ICBT
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2020-02-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: System Usability Scale
timeFrame: immediately after the intervention
measure: Treatment Credibility Scale
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Negative Effects Questionnaire
timeFrame: immediately after the intervention
measure: Negative Effects Questionnaire
timeFrame: During the intervention: 2 weeks from baseline
measure: Patient Health Questionnaire - 9
timeFrame: Change from baseline immediately after the intervention
measure: Generalized Anxiety Disorder - 7
timeFrame: Change from baseline immediately after the intervention
measure: System Usability Scale
timeFrame: During the intervention: 2 weeks from baseline
measure: Treatment Credibility Scale
timeFrame: During the intervention: 2 weeks from baseline
Other outcomes:
measure: Evaluation of treatment format
timeFrame: During the intervention: 2 weeks from baseline
measure: Evaluation of treatment format
timeFrame: immediately after the intervention
measure: Interview concerning treatment format
timeFrame: immediately after the intervention
Locations:
city: Stockholm
country: Sweden
facility: Centrum för Psykiatriforskning
Study officials:
References: