Psychological Phenomena and ProcessesNCT04244617
Peer-supported Internet Mediated Psychological Treatment
A study testing iCBT with addition of peer-support in people with Psychological Phenomena and Processes and Behavior and Behavior Mechanisms, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
This study evaluates the effect and experience of peer-support in internet mediated ACT (Acceptance and Commitment therapy) in an explorative pilot study with mixed method design conducted in primary care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Phenomena and Processes, Behavior and Behavior Mechanisms, Mental Disorder
- What is being tested?
- iCBT with addition of peer-support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2019to 30 Oct 2019
- 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
- participants must have reached the age of 18
- have access to a computer with internet Connection
- speak and understand Swedish
- meet the diagnostic criteria for an anxiety disorder (social anxiety, GAD, panic disorder, obsessive-compulsive disorder, or unspecified anxiety disorder).
Who cannot join
- have started medication or have made major changes regarding their medication in the past few months
- have serious suicidal ideation or suicide plans
- are expected to have complex problems or be in need of other care
- are under any other psychological treatment during the time of the treatment period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peer-supported Internet Mediated Psychological Treatment for Adults With Anxiety Disorders in Primary Care
This study evaluates the effect and experience of peer-support in internet mediated ACT (Acceptance and Commitment therapy) in an explorative pilot study with mixed method design conducted in primary care. Peer-supporters are certified support persons with personal experience of mental health problems and the process of rehabilitation, which becomes professionally active in care and support to patients in their recovery
Read the detailed description
The study is a mixed methods design consisting of an un-controlled pragmatic effectiveness study combined with semi-structured interviews in order to investigate the participant´s experience of treatment. Participants were recruited from patients who were referred to a central unit for internet- CBT (Cognitive Behavioral therapy) in primary care in Västra Götaland region, Sweden. Peer-supporters were recruited through a swedish patient organization. Participants were adults 18 years of age or older with an anxiety disorder.
All participants were interviewed by a psychologist with a diagnostic instrument, a structured interview called PRIME-MD, before starting treatment. After the interview, all patients who were offered iCBT and met the inclusion criteria were requested to participate in the study.
Patients who accepted inclusion were guided by both a psychologist and a peer-support in the iCBT treatment used in the study. The iCBT treatment program used is a transdiagnostic program aimed at treating people with mild to moderate anxiety problems.
Quantitative data about psychosocial symptoms were collected, and qualitative data about the participants experience of treatment were collected through semi-structured interviews.
- Conditions
- Psychological Phenomena and Processes, Behavior and Behavior Mechanisms, Mental Disorder, Behavioral Disciplines and Activities
- Being tested
- iCBT with addition of peer-support
- Keywords
- iCBT, Primary Care, Anxiety, Drop-out, Peer-support, Mixed method design
- Medical subject headings
- Behavior, Mental Disorders, Motor Activity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBT with addition of peer-supportBehavioural
Peer-supporters and participants, as well as psychologists and participants, interact in the treatment program via asynchronous secure messages. Peer-supporters are able to give support and feedback on exercises. A reconciliation call via telephone is entered into the middle of the treatment and a follow-up call after completion of treatment conducted by the peer-support. The interaction between peer-supporters and participants is tracked by the psychologist.
| Study group | Role | What they receive |
|---|---|---|
| iCBT with addition of peer-support (iCBT-PS) | Experimental | Participants in the iCBT-PS, are guided by both a psychologist and a peer-support in the iCBT-program used in the study. Receives: Behavioral: iCBT with addition of peer-support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety symptoms
Anxiety is measured with the GAD-7 instrument (Generalized Anxiety Disorder 7 item scale). The scale consists of 7 items. The score ranges from 0 to 21, with higher scores indicating more anxiety symptoms. There are thresholds for mild, medium and severe anxiety (Spitzer, Kroenke, Williams \& Löwe 2006).
Measured: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up
Change in Depressive symptoms
Symptoms of depression is measured with Madrs-s (Montgomery Åsberg Depression Rating Scale; Montgomery \& Åsberg, 1979). The instrument consists of 9 items. Scores ranges from 0 to 60, with higher scores indicating more depressive symptoms. There are cut-off points for symptom severity.
Measured: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up
Change in symptoms of psychological distress
Symptoms of psychological distress is measured with the CORE-10 (Barkham et al., 2012). Score ranges from 0 to 40, with higher scores indicating more psychological distress. The instrument consists of 10 items and has clinical cut-off scores for general psychological distress.
Measured: Baseline (Pre-treatment) and post treatment (after 8 weeks) (Since this instrument is provided in connection with the modules in the treatment program
Changes in feelings of empowerment
Empowerment is measured with the Empowerment Scale (Rogers, Chamberlin, Ellison \& Crean, 1997). The scale consists of 28 items which are answered on a four-point likert scale. Score ranges between 28 and 112. Higher scores indicates that the person feels more empowered.
Measured: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Mar 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Phenomena and ProcessesStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Model description
- The study is a mixed methods design consisting of an un-controlled pragmatic effectiveness study combined with semi-structured interviews
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sandra Weineland, PhD, Study chair, Department of psychology, University of Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244617
- Sponsor's protocol ID
- Drn EPN: 845-18
- Status last verified
- Jan 2020
- First submitted
- 20 Jan 2020
- Last updated
- 28 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the data if a corresponding author or otherwise authorized person asks for it
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-supported Internet Mediated Psychological Treatment for Adults With Anxiety Disorders in Primary Care
- ClinicalTrials.gov ID
- NCT04244617
- Acronym / sponsor ID
- Drn EPN: 845-18
- Conditions
- Psychological Phenomena and Processes, Behavior and Behavior Mechanisms, Mental Disorder, Behavioral Disciplines and Activities
- Keywords
- iCBT, Primary Care, Anxiety, Drop-out, Peer-support, Mixed method design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 28 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.
This study evaluates the effect and experience of peer-support in internet mediated ACT (Acceptance and Commitment therapy) in an explorative pilot study with mixed method design conducted in primary care. Peer-supporters are certified support persons with personal experience of mental health problems and the process of rehabilitation, which becomes professionally active in care and support to patients in their recovery
Detailed description
The study is a mixed methods design consisting of an un-controlled pragmatic effectiveness study combined with semi-structured interviews in order to investigate the participant´s experience of treatment. Participants were recruited from patients who were referred to a central unit for internet- CBT (Cognitive Behavioral therapy) in primary care in Västra Götaland region, Sweden. Peer-supporters were recruited through a swedish patient organization. Participants were adults 18 years of age or older with an anxiety disorder.
All participants were interviewed by a psychologist with a diagnostic instrument, a structured interview called PRIME-MD, before starting treatment. After the interview, all patients who were offered iCBT and met the inclusion criteria were requested to participate in the study.
Patients who accepted inclusion were guided by both a psychologist and a peer-support in the iCBT treatment used in the study. The iCBT treatment program used is a transdiagnostic program aimed at treating people with mild to moderate anxiety problems.
Quantitative data about psychosocial symptoms were collected, and qualitative data about the participants experience of treatment were collected through semi-structured interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a mixed methods design consisting of an un-controlled pragmatic effectiveness study combined with semi-structured interviews
| Arm | Type | Receives |
|---|---|---|
| iCBT with addition of peer-support (iCBT-PS) | Experimental | Behavioral: iCBT with addition of peer-supportParticipants in the iCBT-PS, are guided by both a psychologist and a peer-support in the iCBT-program used in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- participants must have reached the age of 18
- have access to a computer with internet Connection
- speak and understand Swedish
- meet the diagnostic criteria for an anxiety disorder (social anxiety, GAD, panic disorder, obsessive-compulsive disorder, or unspecified anxiety disorder).
Key exclusion criteria (4 listed)
- have started medication or have made major changes regarding their medication in the past few months
- have serious suicidal ideation or suicide plans
- are expected to have complex problems or be in need of other care
- are under any other psychological treatment during the time of the treatment period.
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 |
|---|---|---|
| iCBT with addition of peer-supportPeer-supporters and participants, as well as psychologists and participants, interact in the treatment program via asynchronous secure messages. Peer-supporters are able to give support and feedback on exercises. A reconciliation call via telephone is entered into the middle of the treatment and a follow-up call after completion of treatment conducted by the peer-support. The interaction between peer-supporters and participants is tracked by the psychologist. | Behavioural | iCBT with addition of peer-support (iCBT-PS) |
Primary outcome
Change in Anxiety symptoms
Time frame: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up
Anxiety is measured with the GAD-7 instrument (Generalized Anxiety Disorder 7 item scale). The scale consists of 7 items. The score ranges from 0 to 21, with higher scores indicating more anxiety symptoms. There are thresholds for mild, medium and severe anxiety (Spitzer, Kroenke, Williams \& Löwe 2006).
Change in Depressive symptoms
Time frame: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up
Symptoms of depression is measured with Madrs-s (Montgomery Åsberg Depression Rating Scale; Montgomery \& Åsberg, 1979). The instrument consists of 9 items. Scores ranges from 0 to 60, with higher scores indicating more depressive symptoms. There are cut-off points for symptom severity.
Change in symptoms of psychological distress
Time frame: Baseline (Pre-treatment) and post treatment (after 8 weeks) (Since this instrument is provided in connection with the modules in the treatment program
Symptoms of psychological distress is measured with the CORE-10 (Barkham et al., 2012). Score ranges from 0 to 40, with higher scores indicating more psychological distress. The instrument consists of 10 items and has clinical cut-off scores for general psychological distress.
Changes in feelings of empowerment
Time frame: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up
Empowerment is measured with the Empowerment Scale (Rogers, Chamberlin, Ellison \& Crean, 1997). The scale consists of 28 items which are answered on a four-point likert scale. Score ranges between 28 and 112. Higher scores indicates that the person feels more empowered.
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 28 Jan 2020.
- Individual participant dataSharing planned: Yes. We will share the data if a corresponding author or otherwise authorized person asks for it
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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.
Sandra Weineland, PhD study chair
Department of psychology, University of Gothenburg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCBT with addition of peer-support in people with Psychological Phenomena and Processes and Behavior and Behavior Mechanisms, run by Vastra Gotaland Region 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 4 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 28 Jan 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?
Change in Anxiety symptoms (time frame: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up). The study lists 4 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 28 Jan 2020.