Depressive SymptomsNCT04277793
Feasibility Evaluation of a Monitored Self-guided Cognitive Behavioural Therapy Digital Format
A study testing Monitored self-guided problem solving in people with Depressive Symptoms and Anxiety, run by Karolinska Institutet at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms, Anxiety
- What is being tested?
- Monitored self-guided problem solving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 24 Apr 2020to 11 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Depressive Symptoms, Anxiety
- Being tested
- Monitored self-guided problem solving
- Keywords
- CBT, Digital, Internet-based, Depression, Anxiety, Self-guided, Problem Solving, ICBT
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitored self-guided problem solvingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Monitored self-guided problem solving intervention | Experimental | Monitored self-guided problem solving intervention Receives: Behavioral: Monitored self-guided problem solving |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale
Self-rated assessment of usability, higher score is better
Measured: immediately after the intervention
Treatment Credibility Scale
Self-rated assessment of treatment credibility, higher score is better
Measured: immediately after the intervention
Secondary outcomes (6)
Negative Effects Questionnaire
Self-rated assessment of negative treatment effects, lower score is better
Measured: immediately after the intervention
Negative Effects Questionnaire
Self-rated assessment of negative treatment effects, lower score is better
Measured: During the intervention: 2 weeks from baseline
Patient Health Questionnaire - 9
Self-rated depressive symptoms, lower score is better
Measured: Change from baseline immediately after the intervention
Generalized Anxiety Disorder - 7
Self-rated anxiety symptoms, lower score is better
Measured: Change from baseline immediately after the intervention
System Usability Scale
Self-rated assessment of usability, higher score is better
Measured: During the intervention: 2 weeks from baseline
Treatment Credibility Scale
Self-rated assessment of treatment credibility, higher score is better
Measured: During the intervention: 2 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start24 Apr 2020
- Primary completion11 Dec 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Martin Kraepelien, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277793
- Sponsor's protocol ID
- SVPSY290/19
- Status last verified
- Dec 2020
- First submitted
- 11 Feb 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04277793
- Acronym / sponsor ID
- SVPSY290/19
- Conditions
- Depressive Symptoms, Anxiety
- Keywords
- CBT, Digital, Internet-based, Depression, Anxiety, Self-guided, Problem Solving, ICBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitored self-guided problem solving intervention | Experimental | Behavioral: Monitored self-guided problem solvingMonitored self-guided problem solving intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitored self-guided problem solvingProblem 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. | Behavioural | Monitored self-guided problem solving intervention |
Primary outcome
System Usability Scale
Time frame: immediately after the intervention
Self-rated assessment of usability, higher score is better
Treatment Credibility Scale
Time frame: immediately after the intervention
Self-rated assessment of treatment credibility, higher score is better
6 secondary outcomes
Negative Effects Questionnaire
Time frame: immediately after the intervention
Negative Effects Questionnaire
Time frame: During the intervention: 2 weeks from baseline
Patient Health Questionnaire - 9
Time frame: Change from baseline immediately after the intervention
Generalized Anxiety Disorder - 7
Time frame: Change from baseline immediately after the intervention
System Usability Scale
Time frame: During the intervention: 2 weeks from baseline
Treatment Credibility Scale
Time frame: During the intervention: 2 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitored self-guided problem solving in people with Depressive Symptoms and Anxiety, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.