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SchizophreniaEviBaSNCT02974400

Evaluation of Internet-based Cognitive Behavioral Self-help Treatments for People With Psychosis

A study testing Internet-based, CBT-oriented, guided self-help in people with Schizophrenia and Hallucinations, run by University of Bern at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Schizophrenia is a severe mental disorder which is accompanied by an enormous individual and societal burden. Despite established efficacy of cognitive behavioral therapy for psychosis (CBTp), its dissemination into routine mental health care remains poor. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Internet-based, CBT-oriented, guided self-help
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
2 sitesin 2 countries
Study dates
6 Dec 2016to 16 Apr 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

  • Electronic informed consent
  • Internet access
  • Adequate command of the German language
  • PANSS Suspiciousness/persecution >= 3 AND/OR PANSS hallucinations >=3
  • Diagnosis of schizophrenia, schizoaffective disorder or delusional disorder
  • Concurrent psychopharmacological treatment

Who cannot join

  • Acute suicidality
  • Acute risk of endangering others
  • No emergency plan (with is formulated during the telephone interview)
  • Disease of the central nervous system with need for treatment

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Germany1 site

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

Other trials in Germany

Switzerland1 site

  • University of Bern

    Bern, 3012

Other trials in Switzerland

About this study

Official title: Evaluation of Internet-based Cognitive Behavioral Self-help Treatments for Persecutory Ideation and Auditory Verbal Hallucinations

Schizophrenia is a severe mental disorder which is accompanied by an enormous individual and societal burden. Despite established efficacy of cognitive behavioral therapy for psychosis (CBTp), its dissemination into routine mental health care remains poor. National regulations such as the National Institute for Health and Care Excellence (NICE) guideline in the United Kingdom recommend that CBTp should be offered to every person with psychotic symptoms, but more than 50% do not receive even a single session of CBTp. In Germany, CBTp is virtually not represented in the psychotherapy health service. Internet-based cognitive behavioral therapy (CBT) in a self-help format has been proven feasible and effective in anxiety and depressive disorders. Recently, Internet-based (self-help) interventions are also deployed via smartphone apps. The feasibility of Internet-based treatments for people with schizophrenia is well documented for Internet-based interventions (e.g., medication management) and also reported for smartphone interventions. However, there is a dearth of empirical studies precluding a conclusive picture. As far as the investigators know, there is only one study encompassing 90 participants with psychosis that investigated an Internet-based intervention with symptom-specific, cognitive behavioral interventions, which is from the investigators' research group. The unique features of the proposed project are 1) the first-time evaluation of a symptom-oriented, CBTp-based self-help treatment for people with psychotic symptoms via Internet, enhanced with smartphone assistance. The study is set up as randomized controlled trial (RCT) with active treatment versus a wait-list control group. It evaluates a combined Internet-based guided self-help treatment for persecutory ideation and auditory verbal hallucinations. The active treatment condition consists of access to a self-help website including regular written electronic contact with a guide and access to smartphone-based interactive worksheets (apps). The trials combine the low-threshold advantages of an online approach (e.g., anonymity) with the virtues of a clinical trial (e.g., symptom assessment and diagnostic verification via Interview). The primary outcome measure is the Positive and Negative Syndrome Scale (PANSS). Secondary outcome measures include self-reported symptom measures (Paranoia Checklist; Beliefs About Voices Questionnaire revised), completion rates, drop-out from the intervention, general symptomatology, side-effects, and client satisfaction. The project will help to answer the empirical question whether CBTp-based interventions in a purely Internet-based self-help format are effective. Positive findings would pave the way for an easy-to-access treatment option for patients with psychotic symptoms who currently are deprived of psychotherapeutic treatment.

Being tested
Internet-based, CBT-oriented, guided self-help
Keywords
internet-based intervention, e-mental health, cognitive behavioural intervention
Medical subject headings
Schizophrenia, Hallucinations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet-based, CBT-oriented, guided self-helpBehavioural

    The self-help program includes sessions regarding (1) cognitive model, (2) sleep hygiene, (3) mindfulness, (4) meta-cognition, (5) coping with voice hearing, (6) persecutory ideation, (7) worrying, (8) self-esteem, (9) depression, (10) social competence, and (11) relapse prevention.

Study groups in NCT02974400
Study groupRoleWhat they receive
Internet-based guided self-helpExperimentalInternet-based, guided, CBT-oriented self-help treatment for persecutory ideation and auditory verbal hallucinations with access to a self-help website including regular written electronic contact with a guide and access to smartphone-based interactive worksheets (8 weeks)
Receives: Behavioral: Internet-based, CBT-oriented, guided self-help
Wait-ListNo interventionWait-list control group (8 weeks)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive and Negative Syndrome Scale (PANSS)

    Kay et al. (1987); clinician administered

    Measured: Change in PANSS from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)

Secondary outcomes (5)

  1. Paranoia Checklist (PC)

    Freeman et al. (2005); self-report

    Measured: Change in PC from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)

  2. Launay-Slade Hallucination Scale (LSHS)

    Bentall \& Slade (1985); self-report

    Measured: Change in LSHS from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)

  3. Patient Health Questionnaire (PHQ-9)

    Spitzer, Kroenke \& Williams, 1999; self-report

    Measured: Change in PHQ-9 from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)

  4. Incongruence Scale (INK)

    Grosse Holtforth, Grawe \& Tamcan (2004); self-report

    Measured: Change in INK from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)

  5. Quality of life (WHO-QOL)

    WHO; self-report

    Measured: Change in WHO-QOL from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2016 (estimated)
  2. Study start6 Dec 2016
  3. Primary completion16 Apr 2019
  4. Study completion16 Apr 2019

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02974400
Sponsor's protocol ID
159384
Acronym
EviBaS
Status last verified
May 2019
First submitted
16 Nov 2016
Last updated
9 May 2019
Results posted
No
Data monitoring committee
No

Publications

  • Westermann S, Ruegg N, Ludtke T, Moritz S, Berger T. Internet-based self-help for psychosis: Findings from a randomized controlled trial. J Consult Clin Psychol. 2020 Oct;88(10):937-950. doi: 10.1037/ccp0000602. Epub 2020 Aug 13.

    PubMed 32790453

  • Ludtke T, Platow-Kohlschein H, Ruegg N, Berger T, Moritz S, Westermann S. Mindfulness Mediates the Effect of a Psychological Online Intervention for Psychosis on Self-Reported Hallucinations: A Secondary Analysis of Voice Hearers From the EviBaS Trial. Front Psychiatry. 2020 Apr 3;11:228. doi: 10.3389/fpsyt.2020.00228. eCollection 2020.

    PubMed 32308631

  • Ruegg N, Moritz S, Berger T, Ludtke T, Westermann S. An internet-based intervention for people with psychosis (EviBaS): study protocol for a randomized controlled trial. BMC Psychiatry. 2018 Apr 13;18(1):102. doi: 10.1186/s12888-018-1644-8.

    PubMed 29653532

Questions about this trial

What is this clinical trial studying?

A study testing Internet-based, CBT-oriented, guided self-help in people with Schizophrenia and Hallucinations, run by University of Bern at 2 sites in 2 countries.

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 6 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 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, Switzerland. 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?

Positive and Negative Syndrome Scale (PANSS) (time frame: Change in PANSS from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)). 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 NCT02974400, which also lists 3 linked publications.

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 9 May 2019.

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