Goals in Focus: CBT for Motivational Negative Symptoms of Psychosis

NCT ID: NCT05252039

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2024-12-31

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.

Conditions

Psychosis; Schizophrenia; Negative Symptoms With Primary Psychotic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Goals in Focus Therapy

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

Group Type: EXPERIMENTAL

Goals in Focus

Intervention Type: 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.

Waitlist Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Goals in Focus

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Matthias Pillny

Trial Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tania M Lincoln, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universität Hamburg

Locations

Psychotherapeutische Hoschschulambulanz Universität Hamburg

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Matthias Pillny, Dr.

Role: CONTACT

matthias.pillny@uni-hamburg.de

+4940428384023

Facility Contacts

Anne K Fladung, Dr.

Role: primary

anne.fladung@uni-hamburg.de

References

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.

Reference Type: DERIVED

PMID: 37131247 (View on PubMed)

Other Identifiers

DRKS00018083

Identifier Type: -

Identifier Source: org_study_id