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

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04277793
• Other study ID #: SVPSY290/19
• Status: Completed
• Phase: N/A
• Start date: April 24, 2020
• Est. completion date: December 11, 2020

Study information

• Verified date: December 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 11, 2020
• Est. primary completion date: December 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 A°sberg 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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Monitored self-guided problem solving
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.

Locations

Country	Name	City	State
Sweden	Centrum för Psykiatriforskning	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of treatment format	Written quantitative and qualitative questions concerning the treatment format	During the intervention: 2 weeks from baseline
Other	Evaluation of treatment format	Written quantitative and qualitative questions concerning the treatment format	immediately after the intervention
Other	Interview concerning treatment format	Phone interview with qualitative questions concerning the treatment format	immediately after the intervention
Primary	System Usability Scale	Self-rated assessment of usability, higher score is better	immediately after the intervention
Primary	Treatment Credibility Scale	Self-rated assessment of treatment credibility, higher score is better	immediately after the intervention
Secondary	Negative Effects Questionnaire	Self-rated assessment of negative treatment effects, lower score is better	immediately after the intervention
Secondary	Negative Effects Questionnaire	Self-rated assessment of negative treatment effects, lower score is better	During the intervention: 2 weeks from baseline
Secondary	Patient Health Questionnaire - 9	Self-rated depressive symptoms, lower score is better	Change from baseline immediately after the intervention
Secondary	Generalized Anxiety Disorder - 7	Self-rated anxiety symptoms, lower score is better	Change from baseline immediately after the intervention
Secondary	System Usability Scale	Self-rated assessment of usability, higher score is better	During the intervention: 2 weeks from baseline
Secondary	Treatment Credibility Scale	Self-rated assessment of treatment credibility, higher score is better	During the intervention: 2 weeks from baseline