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

NCT04277793 | Completed

• 1 other identifier: SVPSY290/19
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Anxiety

Keywords

CBT; Digital; Internet-based; Depression; Anxiety; Self-guided; Problem Solving; ICBT

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Negative Effects Questionnaire

  immediately after the intervention

• Negative Effects Questionnaire

  During the intervention: 2 weeks from baseline

• Patient Health Questionnaire - 9

  Change from baseline immediately after the intervention

• Generalized Anxiety Disorder - 7

  Change from baseline immediately after the intervention

• System Usability Scale

  During the intervention: 2 weeks from baseline

Other Outcomes (3)

• Evaluation of treatment format

  During the intervention: 2 weeks from baseline

• Evaluation of treatment format

  immediately after the intervention

• Interview concerning treatment format

  immediately after the intervention

Study Arms (1)

Monitored self-guided problem solving intervention

EXPERIMENTAL

Monitored self-guided problem solving intervention

Behavioral: Monitored self-guided problem solving

Interventions

Monitored self-guided problem solving BEHAVIORAL

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.

Monitored self-guided problem solving intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Centrum för Psykiatriforskning

Stockholm, Sweden

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Licensed clinical psychologist, Principal investigator, PhD

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 20, 2020
• Study Start: April 24, 2020
• Primary Completion: December 11, 2020
• Study Completion: December 11, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

SE (1)