The Purpose of the Study is to Investigate if a Smartphone App Combined With Internet Based Cognitive Behavioural Therapy (ICBT) Leads to Improved Symtoms in Depressive Adults on Antidepressive Medicine, Compared to a Wait-list Control Condition

NCT06907134 | Active Not Recruiting

• 1 other identifier: FIG
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate if a smartphone app combined with internet delivered cognitive behavioural therapy (ICBT) leads to improved symptoms in depressive adults on antidepressive mediation. The participants in the treatment group will get access to a smartphone app based on CBT-principles for 9 weeks. They will also get access to an internet platform with extra treatment material based on CBT and receive therapist support on demand. Participants will be recruited in Sweden with nationwide recruitment.

Conditions

Depressive Symptoms

Keywords

depressive symtoms; smartphone app; mobile game; internet-based cognitive behavioural therapy

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Ranging Scale (MADRS)

  MADRS-S is a questionnaire including nine questions about depressive mental states. The questions aslo address experienced worry, ability to concentrate and initiative. Each question gives between 0 and 6 points. Maximum score is 54 points. Higher scores indicate higher levels of depression.

  From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.

Secondary Outcomes (2)

• Generalized Anxiety Disorder-7

  From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.

• Brunnsviken Brief Quality of life scale

  From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.

Other Outcomes (3)

• Patient Health Questionnaire - 4

  From enrollment on a weekly basis through study completion 9 weeks later.

• Client Satisfaction Questionnaire

  At week 9 following enrollment.

• The Morisky Medication Adherence Scale

  From enrollment to end of treament at 9 weeks.

Study Arms (2)

Smartphone delivered Internet-based Cognitive Behavioural Therapy

EXPERIMENTAL

The treatment consist of a 9 week long ICBT intervention based on an smartphone app with therapist support on demand.

Behavioral: Smartphone delivered internet-based Cognitive Behavioural Therapy

No Intervention: Wait-list control condition

NO INTERVENTION

Wait-list control condition, participants have the option to contact the treatment team in case of worsened symptoms.

Interventions

Smartphone delivered internet-based Cognitive Behavioural Therapy BEHAVIORAL

The intervention is 9 week long were partipants use an smartphone app based on CBT-principles with while having access to an internet platform where extra working material and therapist support is available on demand.

Smartphone delivered Internet-based Cognitive Behavioural Therapy

Eligibility Criteria

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

You may qualify if:

• Ongoing drug treatment with an antidepressant mediated by an established care contact in (primary) care.
• years or older.
• Be able to speak, read and write Swedish.
• Have access to a computer, tablet or other device with internet connection and smartphone to download the app.

You may not qualify if:

• Severe psychiatric or somatic problems that make participation difficult or impossible
• Ongoing abuse (via Audit and during interview)
• Acute suicidality
• Other ongoing psychological treatment or planned investigation.
• Planned dose change of medicine or change of medicine during pre-measurement.

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linköping University

Linköping, Östergötland County, 58183, Sweden

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Model Details: After the recruitment is finished, participants will be randomized to either ICBT treatment combined with a smartphone app or wait-list control condition.

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: April 2, 2025
• Study Start: November 2, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)