Improving Psychological Therapy for Psychosis: A Case Series

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Psychological Therapy for Psychosis: A Case Series

Conditions
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Psychosis

Intervention / Treatment
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* Behavioral: Experimental intervention arm
* Behavioral: Active control arm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised case series
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental therapy arm<br>16 (minimum 4, maximum 20) sessions of therapy for psychosis including new therapeutic ingredients | Behavioral: Experimental intervention arm<br>* Psychological therapy for psychosis with new therapy components<br>|
| Active Comparator: Standard Psychological Therapy for Psychosis<br>16 (minimum 4 maximum 20) sessions of standard psychological therapy for psychosis. | Behavioral: Active control arm<br>* Standard psychological therapy for psychosis without new therapy components<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Session by session change in positive symptoms as measured by the The Psychotic Symptom Rating Scales (PSYRATS, Haddock et al.,1999). | The PSYRATS is a widely used measure including 17 items assessing different dimensions of delusions and auditory hallucinations that include distress, loudness, conviction, frequency, disruption to life and preoccupation. Each dimension is rated on a 0-4 point scale, with scores on the auditory hallucination subscale (11 items) ranging from 0-44 and scores on the delusion subscale (6 items) ranging from 0-24. Higher scores indicate greater symptom severity. | 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. | 
| Session by session change in cognitive biases measured by Davos Assessment of Cognitive Biases Scales (DACOBS: van der Gaag et al., 2013). | This scale consists of 42 statements relating to seven (six-item) subscales; 1) Jumping to conclusions bias 2) Belief inflexibility bias 3) Attention to threat bias 4) External attribution bias 5) Social cognition problems 6) Subjective cognitive problems and 7) Safety behaviours. Respondents score each statement using a 7-point rating scale, ranging from 'totally disagree' (1) to 'totally agree' (7). For the session-by session data, the subscales Jumping to conclusions, Belief Inflexibility Bias and External Attribution bias subscales will be administered. Each cognitive bias subscale obtains a score from 7-42, with a higher score indicating higher propensity towards a cognitive bias. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jumping to conclusions task (Garety et al., 1991; Moritz et al., 2010). | A computerised task where participants are presented with two lakes of coloured fish in opposing ratios (e.g. Lake A 80% red 20% green, Lake B 80% green 20% red). The participant is told that the fisherman will fish from one of these lakes only (but which lake is unknown). After each catch the participant is asked to make 2 judgements: 1) probability that the fish is caught from lake A or B and 2) Whether they are ready to make a decision on what lake the fish is caught from. This task measures participants tendency to jump to conclusions. | 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. | 
| Bias Against Disconfirmatory Evidence (BADE) task (Woodward et al., 2006) | A computerised version of the BADE task will be employed. In this task, participants will be presented a series of with delusion-neutral scenarios. For each scenario they will be asked to rate the plausibility of 4 interpretations each scenario will have a one true interpretation two lure interpretation and one absurd interpretation. After making their ratings, participants will be presented with additional scenario descriptions, which will provide further information, and participants will be allowed to adjust their ratings if necessary | 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. | 
| Positive and Negative Syndrome Scale (PANSS; Kay et al., 1987) | PANSS is a structured clinical interview that estimates symptom severity for people with schizophrenia and psychosis. The scale consists of 30 items measuring positive (P1-P7), negative (N1-N7) and general (G1-G16) symptom severity. Each of the items is scored on a 1-7 point scale ranging from absent (1) to extreme (7). Total scores range from 30-210, with higher scores indicating greater symptom severity. | 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. | 
| Internalized Stigma of Mental Illness Scale (ISMI; Ritsher et al., 2003) | This is a 29-item questionnaire that assesses subjective levels of self-stigma. Participants are asked to rate the extent to which they agree with a set of statements on a 1-4 point scale scale ranging from strongly disagree (1) to strongly agree (4). Items add up to 5 subscales, including: alienation, stereotype endorsement, discrimination experience, social withdrawal and stigma resistance. Scores for subscales and total scores are calculated by adding the item scores and dividing by total number of answered items, with higher scores indicating higher internalized stigma. | 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. | 
| Calgary Depression Scale for Schizophrenia (CDSS; Addington et al., 1990). | Measures depressive symptoms in schizophrenia. The scale consists of a structured interview with nine questions, and are scored on a 0-3 scale ranging from absent (0) to severe (3). Total score range 0-27 with higher scores indicating higher severity of depressive symptoms. | 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. | 
| Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-18; Ritsner et al., 2005). | An 18-item self-administered questionnaire designed to assess quality of life in patients with psychotic and mood disorders. It is a self-administered scale where participants are asked to rate questions on a 1-5 scale, ranging from not at all or never (1) to Frequently or all of the time (5). Total scores range from 18-90 and a higher score indicates higher a quality of life. | 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. | 
| The Global Assessment of Functioning (GAF; American Psychological Association, APA, 1987) | The GAF scale is a rating scale for assessing a person's psychological, social and occupational functioning. The scale total ranges from 1-100, where a lower score indicates a more severe illness in terms of symptoms and social functioning. | 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. | 
| The Reflective Function Questionnaire (RFQ short version: Fonagy & Ghinai (unpublished manuscript) | 8-item scale to assess mentalising capacity in adults. Total scores range from 8-42. The RFQ-8 contains median scored items where scores in the middle (partly agree or partly disagree) get high scores, while responses in the extreme ends of the scale reflect poor mentalising capacity. | 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. | 
| Change in cognitive biases measured by Davos Assessment of Cognitive Biases Scales (DACOBS: van der Gaag et al., 2013). | This scale consists of 42 statements relating to seven (six-item) subscales; 1) Jumping to conclusions bias 2) Belief Inflexibility bias 3) Attention to threat bias 4) External attribution bias 5) Social cognition problems 6) Subjective cognitive problems and 7) Safety behaviours. Respondents score each statement using a 7- point rating scale, ranging from 'totally disagree' (1) to 'totally agree' (7). Each cognitive bias subscale obtains a score from 7-42, with a higher score indicating higher propensity towards a cognitive bias. | 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. |