Clinical trial NCT03920384: Improving Psychological Therapy for Psychosis: A Case Series
Official title: Improving Psychological Therapy for Psychosis: A Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 19
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised case series
Primary purpose: TREATMENT

Brief summary: Standard psychological therapy for psychosis (Cognitive Behavioural Therapy) is made up of different 'ingredients', also called treatment components. In therapy, different treatment components can be included or excluded depending on the needs of the individual. In this study, the investigators want to find out if standard psychological therapy for psychosis can be improved by including new treatment components. Therefore, participants in this study will be offered psychological therapy for psychosis with new treatment components included or standard psychological therapy for psychosis without new treatment components included. Which of these two options participants are offered will be decided by chance, and during the study neither the study participants nor the researcher will know which of these two variations of psychological therapy are given. Researchers call this a randomized double-blind study. The investigators are aiming to use the results from this study to guide the improvement of psychological therapies for psychosis.

Detailed description: Individuals with psychosis often experience delusions, hallucinations and disorganised thinking. Clinicians call these 'positive symptoms' as they are seen as an addition to regular functioning. Psychosis can also lead to loss of some functions such as lower motivation and decreased interest in activities; these are called 'negative symptoms'. Even though most people receive medication for psychosis, psychological therapies such as Cognitive Behavioural Therapy for psychosis (CBTp) are also important in terms of managing symptoms and increasing well-being. Standard CBTp is made up of different treatment components and in therapy, different treatment components can be included or excluded depending on the needs of the individual. In this study the investigators are looking to identify treatment components that are beneficial to CBTp. In particular, the aim is to test whether adding some newly developed treatment components to CBTp can lead to additional benefits to patients, in terms of reducing unhelpful thinking styles. This will be done through a double-blind randomized case-series design, where participants will either receive standard CBTp or standard CBTp with added treatment components.

Four weeks before the intervention starts, throughout therapy, as well as four weeks after therapy, participants will complete weekly questionnaires to assess symptoms and thinking patterns. This will allow the researcher to measure weekly changes before, during and after the therapy. Additional questionnaires and interviews as well as computer tasks will also be completed before the therapy starts (baseline), mid-therapy and post-therapy to gain more insight into changes in mood, quality of life, thinking patterns and symptoms. In addition, to study the long-term effect of the intervention, participants will be asked to complete a follow-up assessment session 12 weeks after the therapy is completed. Participants and clinicians will also be given the opportunity to give feedback on their experience of having received/delivered the therapy. This will be done through an interview with the researcher, and will give us further insight into how future therapies for psychosis might be improved, both from a clinician and patient perspective.

Eligibility criteria: Inclusion Criteria:

* Are aged 16 or over
* Are competent and willing to provide written, informed consent
* Are experiencing delusions (A score of ≥3 on PANSS item P1, P5 or P6)

Exclusion Criteria:

* Significant developmental disability
* Currently receiving or have received CBTp in the last 6 months
* Significant difficulty with the English language

Primary outcomes:
measure: Session by session change in positive symptoms as measured by the The Psychotic Symptom Rating Scales (PSYRATS, Haddock et al.,1999).
timeFrame: Administered weekly 4 weeks prior to therapy start, weekly after each therapy session (maximum 20 sessions) and weekly for 4 weeks after therapy intervention has been completed as well as 12 weeks follow-up after intervention completion.
measure: Session by session change in cognitive biases measured by Davos Assessment of Cognitive Biases Scales (DACOBS: van der Gaag et al., 2013).
timeFrame: Assessed weekly for 4 weeks prior to therapy start, weekly after each therapy session (maximum 20 sessions) and weekly for 4 weeks after therapy intervention has been completed.
Secondary outcomes:
measure: Jumping to conclusions task (Garety et al., 1991; Moritz et al., 2010).
timeFrame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
measure: Bias Against Disconfirmatory Evidence (BADE) task (Woodward et al., 2006)
timeFrame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
measure: Positive and Negative Syndrome Scale (PANSS; Kay et al., 1987)
timeFrame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
measure: Internalized Stigma of Mental Illness Scale (ISMI; Ritsher et al., 2003)
timeFrame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
measure: Calgary Depression Scale for Schizophrenia (CDSS; Addington et al., 1990).
timeFrame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-18; Ritsner et al., 2005).
timeFrame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
measure: The Global Assessment of Functioning (GAF; American Psychological Association, APA, 1987)
timeFrame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
measure: The Reflective Function Questionnaire (RFQ short version: Fonagy & Ghinai (unpublished manuscript)
timeFrame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
measure: Change in cognitive biases measured by Davos Assessment of Cognitive Biases Scales (DACOBS: van der Gaag et al., 2013).
timeFrame: Full scale administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
Other outcomes:
measure: Qualitative questions post-intervention
timeFrame: Interview will be done after participants have completed the therapy intervention (an average of 6 months after study commencement). Trial therapists will be interviewed once their study interventions are completed with trial participants.
Locations:
city: Edinburgh
country: United Kingdom
facility: Lothian NHS Board
state: Scotland
Study officials:
affiliation: University of Edinburgh
name: Emma Eliasson
role: PRINCIPAL_INVESTIGATOR
References: