Problems With Self-assertivenessR2NCT04240249
Constructive Self Assertiveness Via the Internet
A study testing Constructive self-assertiveness program via the internet in people with Problems With Self-assertiveness, run by Stockholm University at 1 site in Sweden.
Trial summary
Some people have problems with self-assertiveness. That can have negative impact on their lives. This study will test a constructive self-assertiveness intervention program delivered online. In addition, the relative effect of guidance during the intervention will be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Problems With Self-assertiveness
- What is being tested?
- Constructive self-assertiveness program via the internet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2020to 31 Dec 2022
- 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
- Human,
- At least 18 years old,
- Able to speak and read Swedish,
- Informed consent.
Who cannot join
- Severe depression (as defined by a PHQ9 score of 15 points or higher),
- If on medication the dosage has been stable for at least the past 3 months,
- No ongoing psychotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Some people have problems with self-assertiveness. That can have negative impact on their lives. This study will test a constructive self-assertiveness intervention program delivered online. In addition, the relative effect of guidance during the intervention will be investigated.
In a randomized controlled trial three groups will be compared:
- constructive self-assertiveness with guidance
- constructive self-assertiveness without guidance
- Waitlist control
Read the detailed description
Some people have problems with self-assertiveness. That can have negative impact on their lives. This study will test a constructive self-assertiveness intervention program delivered online. In addition, the relative effect of guidance during the intervention will be investigated.
In a randomized controlled trial three groups will be compared:
- constructive self-assertiveness with guidance
- constructive self-assertiveness without guidance
- Waitlist control
The treatment (and wait) will be 10 weeks.
- Conditions
- Problems With Self-assertiveness
- Being tested
- Constructive self-assertiveness program via the internet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constructive self-assertiveness program via the internetBehavioural
Participants will get one "chapter" a week to work with. All chapters are presented on web pages and include information and exercises and end with homework assignments.
| Study group | Role | What they receive |
|---|---|---|
| Constructive self-assertiveness with guidance | Experimental | 10 weeks of internet-based treatment with weekly assignments. The homework is commented on by the guide using electronic communication. Receives: Behavioral: Constructive self-assertiveness program via the internet |
| Constructive self-assertiveness without guidance | Experimental | 10 weeks of internet-based treatment with weekly assignments. The homework is NOT commented on by any guide. Hence, same treatment as group 1 but without guidance. Receives: Behavioral: Constructive self-assertiveness program via the internet |
| Waitlist control | No intervention | No treatment, no guidance, just waiting for 10 weeks. After the ten weeks the participants will receive the treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptive and Aggressive Assertiveness Scale
A self-report questionnaire measuring Adaptive and Aggressive Assertiveness. Higher scores mean a worse outcome. Minimum and maximum values: 30-150.
Measured: Up to 12 months
Secondary outcomes (5)
Patient Health Questionnaire 9-item
Depression questionnaire. Higher scores mean a worse outcome. Higher scores mean a worse outcome. Minimum and maximum values: 0-27.
Measured: Up to 12 months
Generalized Anxiety Disorder 7
General Anxiety questionnaire. Higher scores mean a worse outcome. Minimum and maximum values: 0-27.
Measured: Up to 12 months
Liebowitz Social Anxiety Scale , self-report
Social Anxiety questionnaire. Higher scores mean a worse outcome. Minimum and maximum values: 0-144.
Measured: Up to 12 months
Rathus Assertiveness Schedule
Assertiveness questionnaire. Higher scores mean a worse outcome. Minimum and maximum values: -30 to +30.
Measured: Up to 12 months
Well-being scale
Depression scale. Lower scores mean a worse outcome. Minimum and maximum values: 0-72.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Feb 2020
- Primary completion16 May 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Problems With Self-assertivenessStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial with three groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stockholm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Carlbring, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240249
- Sponsor's protocol ID
- Respect
- Acronym
- R2
- Status last verified
- Apr 2024
- First submitted
- 15 Jan 2020
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Analytic code and pseudoanonymous data in a data repository.
Publications
Hagberg T, Manhem P, Oscarsson M, Michel F, Andersson G, Carlbring P. Efficacy of transdiagnostic cognitive-behavioral therapy for assertiveness: A randomized controlled trial. Internet Interv. 2023 May 13;32:100629. doi: 10.1016/j.invent.2023.100629. eCollection 2023 Apr.
PubMed 37273933
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constructive Self Assertiveness Via the Internet
- ClinicalTrials.gov ID
- NCT04240249
- Acronym / sponsor ID
- R2 / Respect
- Conditions
- Problems With Self-assertiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Stockholm UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 16 May 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 Jan 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.
Some people have problems with self-assertiveness. That can have negative impact on their lives. This study will test a constructive self-assertiveness intervention program delivered online. In addition, the relative effect of guidance during the intervention will be investigated.
In a randomized controlled trial three groups will be compared:
- constructive self-assertiveness with guidance
- constructive self-assertiveness without guidance
- Waitlist control
Detailed description
Some people have problems with self-assertiveness. That can have negative impact on their lives. This study will test a constructive self-assertiveness intervention program delivered online. In addition, the relative effect of guidance during the intervention will be investigated.
In a randomized controlled trial three groups will be compared:
- constructive self-assertiveness with guidance
- constructive self-assertiveness without guidance
- Waitlist control
The treatment (and wait) will be 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized controlled trial with three groups.
| Arm | Type | Receives |
|---|---|---|
| Constructive self-assertiveness with guidance | Experimental | Behavioral: Constructive self-assertiveness program via the internet10 weeks of internet-based treatment with weekly assignments. The homework is commented on by the guide using electronic communication. |
| Constructive self-assertiveness without guidance | Experimental | Behavioral: Constructive self-assertiveness program via the internet10 weeks of internet-based treatment with weekly assignments. The homework is NOT commented on by any guide. Hence, same treatment as group 1 but without guidance. |
| Waitlist control | No intervention | –No treatment, no guidance, just waiting for 10 weeks. After the ten weeks the participants will receive the treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Human,
- At least 18 years old,
- Able to speak and read Swedish,
- Informed consent.
Key exclusion criteria (3 listed)
- Severe depression (as defined by a PHQ9 score of 15 points or higher),
- If on medication the dosage has been stable for at least the past 3 months,
- No ongoing psychotherapy.
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 |
|---|---|---|
| Constructive self-assertiveness program via the internetParticipants will get one "chapter" a week to work with. All chapters are presented on web pages and include information and exercises and end with homework assignments. | Behavioural | Constructive self-assertiveness with guidance, Constructive self-assertiveness without guidance |
Primary outcome
Adaptive and Aggressive Assertiveness Scale
Time frame: Up to 12 months
A self-report questionnaire measuring Adaptive and Aggressive Assertiveness. Higher scores mean a worse outcome. Minimum and maximum values: 30-150.
5 secondary outcomes
Patient Health Questionnaire 9-item
Time frame: Up to 12 months
Generalized Anxiety Disorder 7
Time frame: Up to 12 months
Liebowitz Social Anxiety Scale , self-report
Time frame: Up to 12 months
Rathus Assertiveness Schedule
Time frame: Up to 12 months
Well-being scale
Time frame: Up to 12 months
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 18 Apr 2024.
- Results publication: PubMed 37273933Hagberg T, Manhem P, Oscarsson M, Michel F, Andersson G, Carlbring P. Efficacy of transdiagnostic cognitive-behavioral therapy for assertiveness: A randomized controlled trial. Internet Interv. 2023 May 13;32:100629. doi: 10.1016/j.invent.2023.100629. eCollection 2023 Apr.
- Individual participant dataSharing planned: Yes. Analytic code and pseudoanonymous data in a data repository.
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 Constructive self-assertiveness program via the internet in people with Problems With Self-assertiveness, run by Stockholm University 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 4 inclusion and 3 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 18 Apr 2024. 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?
Adaptive and Aggressive Assertiveness Scale (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04240249, which also lists 1 linked publication.
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 18 Apr 2024.