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SchizophreniaPhase 2NCT04990414

Cognitive Behaviour Therapy for Voices and Dissociation

A Phase 2 study testing Cognitive Behavioural Therapy in people with Schizophrenia and Psychological Trauma, run by Greater Manchester Mental Health NHS Foundation Trust.

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

Case series design with participants with psychosis with a history of interpersonal trauma/abuse and current distressing auditory verbal hallucinations and dissociative experience. Participants were offered up to 24 therapy sessions over a 6-month intervention window. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Schizophrenia, Psychological Trauma, Dissociation
What is being tested?
Cognitive Behavioural Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
No sites listed yet
Study dates
24 Nov 2013to 29 Jan 2019
Phase
Phase 2
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Be in contact with mental health services.
  • Have an identified care coordinator.
  • Meet ICD-10 criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an Early Intervention in Psychosis service in order to allow for diagnostic uncertainty in early phases of psychosis.
  • History of voice-hearing for a minimum of six months.
  • Aged 16 and above.
  • Score ≥ 2 (i.e. "Voices occurring at least once a day") on the frequency item of the PSYRATS.
Show all 12Show fewer
  • Score ≥ 3 (i.e. "Voices are very distressing, although subject could feel worse") on the distress intensity rating of the PSYRATS.
  • Confirmed that they consider AVHs, dissociative experiences, and/or trauma as their main problem or presenting difficulty, and that would like to receive a psychological intervention specifically designed to address these difficulties - this will be assessed using four items integrated in the PSYRATS interview administered as part of the present study, and the self-reported therapy goals generated through the CHOICE short form.
  • Score ≥ 1 on any of the items of the Bref Betrayal Trauma Survey assessing lifetime exposure to interpersonal trauma (i.e. items 3-11).
  • scores suggestive of clinical levels of dissociative symptoms, as indicated by a score > 20 on the Dissociative Experiences Scale, time bound
  • Capacity to provide informed consent.
  • Judged by their clinician to be clinically stable for the preceding 4 weeks

Who cannot join

  • Any person without capacity to provide written informed consent.
  • If the experience of voices/psychosis is organic in origin (for example, hallucinatory experiences linked to traumatic brain injuries, organic psychoses, or emerging in the context of dementing conditions).
  • Insufficient command of English to complete the research interviews and measures.
  • Intellectual disability, or severe cognitive dysfunction that might preclude the individual's ability to provide informed consent, understand the study procedure and/or fully appreciate the potential consequences of their participation.
  • Primary diagnosis of substance misuse dependency.
  • Where care coordinators identify reasons for why participation might be potentially detrimental.
  • Inpatient/acute care needed.

About this study

Official title: Cognitive Behaviour Therapy for Voices and Dissociation: A Case Series

Case series design with participants with psychosis with a history of interpersonal trauma/abuse and current distressing auditory verbal hallucinations and dissociative experience. Participants were offered up to 24 therapy sessions over a 6-month intervention window.

Read the detailed description

Objectives: Previous studies have suggested that dissociation might represent an important mechanism in the maintenance of auditory verbal hallucinations (i.e., voices) in people who have a history of traumatic life experiences. This study investigated whether a cognitive behavioural therapy (CBT) intervention for psychosis augmented with techniques specifically targeting dissociative symptoms could improve both dissociation and auditory hallucination severity in a sample of voice hearers with psychosis and a history of interpersonal trauma (e.g., exposure to sexual, physical, and/or emotional abuse).

Design: Case series.

Methods: A total of 19 service users with psychosis were offered up to 24 therapy sessions over a 6-month intervention window. Participants were assessed four times over a 12-month period using measures of dissociation, psychotic symptoms severity, and additional secondary mental-health and recovery measures.

Being tested
Cognitive Behavioural Therapy
Medical subject headings
Schizophrenia, Psychological Trauma, Dissociative Disorders, Hallucinations

What participants receive

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

  • Cognitive Behavioural TherapyOther

    Sessions 1-4 were focused on engagement, assessment of presenting problems, identification of treatment goals and normalization/ psychoeducation. Sessions 5- 14, focused on techniques to manage dissociative responses and/or increase perceived controllability of dissociation. Although further work on dissociation and/or trauma was encouraged, the targets for intervention in subsequent sessions (15-22) and the strategies selected depended on individual formulation of clients' difficulties and negotiation with the client. This could include re-appraisals on negative beliefs about dissociative experiences, cognitive and/or behavioural change strategies targeting core appraisals of voices leading to related distress, trauma-related techniques (e.g., imagery techniques,), or consolidation of a developmental/longitudinal psychological formulation of the client's difficulties. The final two sessions focused on plans for relapse prevention and maintenance of gains.

Study groups in NCT04990414
Study groupRoleWhat they receive
CBT for voices and dissociationExperimental24 sessions of Cognitive Behavioural Therapy (CBT) over a 6-month period treatment window.
Receives: Other: Cognitive Behavioural Therapy

What is being measured

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

  1. Change in the Dissociative Experiences Scale - time bound

    Change in the frequency of dissociative experiences, assessed via a questionnaire measure assessing presence and frequency of dissociative experiences in the previous month

    Measured: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment

  2. Change in the Psychotic Symptoms Rating Scale - auditory hallucinations subscale

    change in the severity of hallucinatory experiences, assessed via a clinical interview measuring for presence and severity of auditory hallucinations in the previous week

    Measured: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment

Secondary outcomes (5)

  1. Change in the Psychotic Symptoms Rating Scale - delusions subscale

    change in the severity of delusional beliefs, assessed via a clinical interview measuring for presence and severity of delusions in the previous week

    Measured: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment

  2. Change in the Impact of Events Scale Revised

    change in the severity of post-traumatic symptoms, assessed via a questionnaire measuring arousal, hypervigilance, and intrusions in the previous week

    Measured: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment

  3. Change in the short Depression, Anxiety and Stress Scales

    change in the severity of emotional distress, assessed via a questionnaire measuring symptoms of anxiety, depression, and stress in the previous week

    Measured: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment

  4. Change in the Questionnaire about the Process of Recovery

    change in subjective recovery from psychosis, assed via a self-report questionnaire measuring perceived recovery from psychosis-related difficulties

    Measured: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment

  5. Change in the short-form of the CHoice of Outcome In Cbt for psychosEs (CHOICE)

    change in service user-led outcome measure, assessed using a validated questionnaire developed to evaluate outcomes of cognitive behavioural interventions for psychosis

    Measured: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment

Timeline

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

  1. First posted4 Aug 2021
  2. Study start24 Nov 2013
  3. Primary completion29 Jan 2019
  4. Study completion29 Jan 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Case series
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04990414
Sponsor's protocol ID
x145-119388
Status last verified
Jul 2021
First submitted
24 Jun 2021
Last updated
4 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Varese F, Douglas M, Dudley R, Bowe S, Christodoulides T, Common S, Grace T, Lumley V, McCartney L, Pace S, Reeves T, Morrison AP, Turkington D. Targeting dissociation using cognitive behavioural therapy in voice hearers with psychosis and a history of interpersonal trauma: A case series. Psychol Psychother. 2021 Jun;94(2):247-265. doi: 10.1111/papt.12304. Epub 2020 Sep 10.

    PubMed 32914542

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cognitive Behavioural Therapy in people with Schizophrenia and Psychological Trauma, run by Greater Manchester Mental Health NHS Foundation Trust.

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 12 inclusion and 7 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 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 the Dissociative Experiences Scale - time bound (time frame: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment). 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?

On the ClinicalTrials.gov record for NCT04990414, 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 4 Aug 2021.

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