Improving Psychological Therapy for Psychosis: A Case Series

NCT03920384 | Completed

• 1 other identifier: 203489
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Jumping to conclusions task (Garety et al., 1991; Moritz et al., 2010).

  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)

  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)

  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)

  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).

  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 (1)

• Qualitative questions post-intervention

  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.

Study Arms (2)

Experimental therapy arm

EXPERIMENTAL

16 (minimum 4, maximum 20) sessions of therapy for psychosis including new therapeutic ingredients

Behavioral: Experimental intervention arm

Standard Psychological Therapy for Psychosis

ACTIVE COMPARATOR

16 (minimum 4 maximum 20) sessions of standard psychological therapy for psychosis.

Behavioral: Active control arm

Interventions

Experimental intervention arm BEHAVIORAL

Psychological therapy for psychosis with new therapy components

Experimental therapy arm

Active control arm BEHAVIORAL

Standard psychological therapy for psychosis without new therapy components

Standard Psychological Therapy for Psychosis

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Lothian NHS Board

Edinburgh, Scotland, EH1 3EG, United Kingdom

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Emma Eliasson

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised case series

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: April 18, 2019
• Study Start: March 27, 2018
• Primary Completion: October 5, 2021
• Study Completion: October 5, 2021
• Last Updated: February 28, 2022

Record last verified: 2021-04

Locations

GB (1)