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

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Depressive Symptoms
• Intervention / Treatment: Behavioral: Monitored self-guided problem solving

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Centrum för Psykiatriforskning

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monitored self-guided problem solving 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of treatment format	Written quantitative and qualitative questions concerning the treatment format	During the intervention: 2 weeks from baseline
Evaluation of treatment format	Written quantitative and qualitative questions concerning the treatment format	immediately after the intervention
Interview concerning treatment format	Phone interview with qualitative questions concerning the treatment format	immediately after the intervention

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2020
• Primary Completion (Actual): December 11, 2020
• Study Completion (Actual): December 11, 2020

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Depression; Anxiety; CBT; Problem Solving; Digital; Internet-based; ICBT; Self-guided
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Depression; Anxiety Disorders
• Other Study ID Numbers: SVPSY290/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No