Goals in Focus: CBT for Motivational Negative Symptoms of Psychosis

NCT05252039 | Recruiting

• 1 other identifier: DRKS00018083
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis; Schizophrenia; Negative Symptoms With Primary Psychotic Disorder

Keywords

Amotivation; Avolition; Anhedonia; Asociality

Outcome Measures

Primary Outcomes (1)

• Brief Negative Symptoms Scale (BNSS) - 'motivation and pleasure factor' score

  The primary outcome is defined as the change in motivational negative symptoms assessed with the 'motivation and pleasure factor' of the Brief Negative Symptoms Scale (BNSS). The BNSS is a 13-item semi-structured interview measuring negative symptoms on two factors, namely 'motivation and pleasure' and 'reduced expressivity'. The 'motivation and pleasure factor' includes seven items that measure the subscales of 'anhedonia', 'avolition', and 'asociality'. Symptoms are rated on a seven-point scale ranging from 0 "no impairment" to 6 "severe deficit"

  6 months after baseline assessment

Secondary Outcomes (6)

• Avolition, Asociality and Anhedonia

  6 months after baseline assessment

• Role Functioning Scale (RFS)

  6 months after baseline assessment

• Global Assessment of Functioning (GAF)

  6 months after baseline assessment

• Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)

  6 months after baseline assessment

• Calgary Depression Rating Scale for Schizophrenia (CDSS)

  6 months after baseline assessment

Other Outcomes (10)

• Feasibility referrals

  throughout the trial; approximately two years after recruitment commenced

• Feasibility participant eligibility

  throughout the trial; approximately two years after recruitment commenced

• Feasibility consents

  throughout the trial; approximately two years after recruitment commenced

Study Arms (2)

Goals in Focus Therapy

EXPERIMENTAL

Participants in this arm will receive 24 weekly sessions with Goals in Focus therapy (GiF) over 6 months.

Behavioral: Goals in Focus

Waitlist Control

NO INTERVENTION

Participants in this arm will not receive any psychological treatment for 6 months. After 6-months, they will receive 24 sessions of Goals in Focus Therapy.

Interventions

Goals in Focus BEHAVIORAL

Goals in Focus (GiF) is a symptom-specific treatment program that targets motivational negative symptoms in patients with schizophrenia-spectrum disorders. The aim is to improve setting and pursuit of personal relevant goals. GiF follows a 24-individual-sessions treatment manual. GiF includes five treatment phases: 1) Preparation, 2) Goal-setting, 3) Goal-pursuit, and 4) Reflection and preparation of autonomous goal-pursuit. The interventions include generating positive goals, behavioral activation, training of anticipatory pleasure, challenging demotivating beliefs, training of problem-solving skills and social skills training.

Goals in Focus Therapy

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hamburg-Eppendorf: lead

Study Sites (1)

Psychotherapeutische Hoschschulambulanz Universität Hamburg

Hamburg, 20146, Germany

RECRUITING

Related Publications (1)

• Schormann ALA, Pillny M, Hass K, Lincoln TM. "Goals in Focus"-a targeted CBT approach for motivational negative symptoms of psychosis: study protocol for a randomized-controlled feasibility trial. Pilot Feasibility Stud. 2023 May 2;9(1):72. doi: 10.1186/s40814-023-01284-4.

  PMID: 37131247 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Anhedonia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tania M Lincoln, Prof. Dr.

  Universität Hamburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Pillny, Dr.

CONTACT

+4940428384023; matthias.pillny@uni-hamburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trial Manager

Model Details: prospective, randomized, controlled, parallel-group, two-armed

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 23, 2022
• Study Start: March 1, 2020
• Primary Completion: January 31, 2024
• Study Completion: December 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)