Clinical trial NCT05252039: Goals in Focus: CBT for Motivational Negative Symptoms of Psychosis
Official title: Goals in Focus: CBT for Motivational Negative Symptoms of Psychosis - a Randomized-controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Schizophrenia
Negative Symptoms With Primary Psychotic Disorder
Keywords: Amotivation
Avolition
Anhedonia
Asociality
Lead sponsor: University of Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, controlled, parallel-group, two-armed
Primary purpose: TREATMENT

Brief summary: This pilot feasibility trial aims to evaluate the "Goals in Focus" intervention for motivational negative symptoms in people with psychosis.

Goals in Focus interventions translate findings of basic clinical research on psychological mechanisms of motivational negative symptoms into a tailored and comprehensive novel psychological treatment program.

The current single-blind randomized-controlled study aims to test feasibility and to examine first estimates of the expected effect size of Goals in Focus to inform a subsequent fully-powered RCT.

The feasibility data will be used to improve on the trial design and the provision of the "Goals in Focus" intervention where necessary.

Detailed description: The reduction of goal-directed behavior is a core issue in motivational negative symptoms of psychosis and accounts for the long-term decline in psychological wellbeing and psychosocial functioning. However, the available treatment options are rather unspecific and show only small effects on motivational negative symptoms. Interventions that directly target the relevant psychological mechanisms of motivational negative symptoms are likely to be more effective. With "Goals in Focus", we translated findings of basic clinical research on psychological mechanisms of motivational negative symptoms into a tailored and comprehensive novel psychological treatment program for people with motivational negative symptoms. The current study aims to test the feasibility of Goals in Focus and trial procedures and 2) to estimate the expected effect size to inform a subsequent fully-powered trial.

A single-blind randomized-controlled trial will be conducted at the outpatient clinic of the Universität Hamburg, Germany. Thirty participants diagnosed with a psychotic spectrum disorder and at least moderate motivational negative symptoms will be randomly assigned to either 24 sessions of "Goals in Focus" or to a 6-months waitlist control group. Assessments will be conducted at baseline (t0) and 6 months after baseline completion (t1). Feasibility and acceptance of "Goals in Focus" will be rated by practitioners and participants. Feasibility of the trial procedures will be evaluated, e.g., with regard to patient recruitment, retention-, and attendance rates. The primary outcome for effect size estimation is defined as group differences in motivational negative symptoms at t1, corrected for baseline values. Secondary outcomes include psychosocial functioning, psychological well-being, depressive symptoms, expressive negative symptoms, negative symptom factors and goal-pursuit in everyday life.

The treatment effect on the primary outcomes will provide the basis for the sample size calculation for a fully powered RCT. The feasibility data will be used to improve on the trial design and the provision of the "Goals in Focus" intervention where necessary.

Eligibility criteria: Inclusion Criteria:

* ICD-10 diagnosis of a schizophrenia spectrum disorder (confirmed by the Structured Clinical Interview for DSM V Clinical Version
* at least moderate motivational negative symptoms (i.e., scores ≥ 3 (moderate) in two items or ≥ 4 (moderately severe) in one item of the 'motivation and pleasure factor' of the Brief Negative Symptom Scale (BNSS)
* sufficient skills in German language to participate in psychological therapy
* capable to engage in weekly therapy sessions of 50-minutes
* prioritize the reduction of negative symptoms as their current goal for treatment
* capable to give informed consent to participate in the trial

Exclusion Criteria:

* being at immediate and serious risk to self or others
* co-morbid diagnosis of alcohol or substance use disorder
* intake of Benzodiazepines for \>2 days per week
* receiving any other psychological treatment aiming to reduce motivational negative symptoms

Primary outcomes:
measure: Brief Negative Symptoms Scale (BNSS) - 'motivation and pleasure factor' score
timeFrame: 6 months after baseline assessment
Secondary outcomes:
measure: Avolition, Asociality and Anhedonia
timeFrame: 6 months after baseline assessment
measure: Role Functioning Scale (RFS)
timeFrame: 6 months after baseline assessment
measure: Global Assessment of Functioning (GAF)
timeFrame: 6 months after baseline assessment
measure: Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
timeFrame: 6 months after baseline assessment
measure: Calgary Depression Rating Scale for Schizophrenia (CDSS)
timeFrame: 6 months after baseline assessment
measure: Goal-pursuit within daily-life
timeFrame: 6 months after baseline assessment
Other outcomes:
measure: Feasibility referrals
timeFrame: throughout the trial; approximately two years after recruitment commenced
measure: Feasibility participant eligibility
timeFrame: throughout the trial; approximately two years after recruitment commenced
measure: Feasibility consents
timeFrame: throughout the trial; approximately two years after recruitment commenced
measure: Feasibility retention
timeFrame: throughout the trial; approximately two years after recruitment commenced
measure: Feasibility adherence
timeFrame: throughout the trial; approximately two years after recruitment commenced
measure: Feasibility data attrition
timeFrame: throughout the trial; approximately two years after recruitment commenced
measure: Acceptability participants
timeFrame: throughout the trial; approximately two years after recruitment commenced
measure: Acceptability and trial safety
timeFrame: throughout the trial; approximately two years after recruitment commenced
measure: Treatment satisfaction participants
timeFrame: throughout the trial; approximately two years after recruitment commenced
measure: Treatment satisfaction therapists
timeFrame: throughout the trial; approximately two years after recruitment commenced
Locations:
city: Hamburg
country: Germany
facility: Psychotherapeutische Hoschschulambulanz Universität Hamburg
Study officials:
affiliation: Universität Hamburg
name: Tania M Lincoln, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: