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

NCT02974400 | Completed

• 1 other identifier: 159384
• Study Type: interventional
• Target: 101
• Locations: 2 countries
• Sites: 2

Brief 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. 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.

Conditions

Schizophrenia; Hallucinations; Persecutory Delusion

Keywords

internet-based intervention; e-mental health; cognitive behavioural intervention

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale (PANSS)

  Kay et al. (1987); clinician administered

  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)

• Paranoia Checklist (PC)

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

• Launay-Slade Hallucination Scale (LSHS)

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

• Patient Health Questionnaire (PHQ-9)

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

• Incongruence Scale (INK)

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

• Quality of life (WHO-QOL)

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

Study Arms (2)

Internet-based guided self-help

EXPERIMENTAL

Internet-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)

Behavioral: Internet-based, CBT-oriented, guided self-help

Wait-List

NO INTERVENTION

Wait-list control group (8 weeks)

Interventions

Internet-based, CBT-oriented, guided self-help BEHAVIORAL

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.

Internet-based guided self-help

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (2)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

University of Bern

Bern, 3012, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 32790453 DERIVED

• 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.

  PMID: 32308631 DERIVED

• 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.

  PMID: 29653532 DERIVED

MeSH Terms

Conditions

Schizophrenia; Hallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Westermann, Dr

  University of Bern

  PRINCIPAL INVESTIGATOR

• Steffen Moritz, Prof. Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 28, 2016
• Study Start: December 6, 2016
• Primary Completion: April 16, 2019
• Study Completion: April 16, 2019
• Last Updated: May 9, 2019

Record last verified: 2019-05

Locations

DE (1); CH (1)