Goals in Focus: CBT for Motivational Negative Symptoms of Psychosis (GIF)

Goals in Focus: CBT for Motivational Negative Symptoms of Psychosis - a Randomized-controlled Feasibility Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Psychosis; Negative Symptoms With Primary Psychotic Disorder
• Intervention / Treatment: Behavioral: Goals in Focus

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthias Pillny, Dr.; Phone Number: +4940428384023; Email: matthias.pillny@uni-hamburg.de

Study Locations

• Germany
  • Hamburg, Germany, 20146
    • Recruiting
    • Psychotherapeutische Hoschschulambulanz Universität Hamburg
    • Contact: Anne K Fladung, Dr.; Email: anne.fladung@uni-hamburg.de
    • Principal Investigator: Tania M Lincoln, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Goals in Focus Therapy; Participants in this arm will receive 24 weekly sessions with Goals in Focus therapy (GiF) over 6 months.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Avolition, Asociality and Anhedonia	The respective subscales of the Brief Negative Symptom Scale according to the five-factor model. Each scale ranges from 0 to 6 with higher scores indicating higher symptom severity	6 months after baseline assessment
Role Functioning Scale (RFS)	Psychosocial Functioning across different domains of social roles	6 months after baseline assessment
Global Assessment of Functioning (GAF)	Observer-rating of psychosocial functioning. Ranges from 0 to 100 with higher scores indicating better functioning	6 months after baseline assessment
Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)	Self-reported psychological well-being. Scores range from 14 to 70 with higher scores indicating higher well-being	6 months after baseline assessment
Calgary Depression Rating Scale for Schizophrenia (CDSS)	Semi-structured interview ti assess depressive symptoms. Scores range from 0 to 36 with higher scores indicating more depressive symptoms	6 months after baseline assessment
Goal-pursuit within daily-life	Daily-life goal-pursuit will be assessed using the Experience Sampling Method (ESM). Participants will be prompted two times per day (10am and 10pm) over the course of one week via the MovisensXSapplication (Movisens GmbH) installed on a smartphone device. At the beginning of the ESM assessment, the participants' self-efficacy will be assessed with the Generalized Self-Efficacy Scale (GSE) Each of the following '10am prompts' will ask the participants to nominate a goal that they would like to achieve during the respective day and to rate characteristics of this goal (e.g., goal-commitment, goal-importance, goal-difficulty etc.). At the '10pm prompts', participants will be asked to indicate to what extent they achieved the respective goal and to answer questions on their causal-attributions and affective experience regarding their goal-achievement.	6 months after baseline assessment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility referrals	number of referrals (number of participants referred to the study)	throughout the trial; approximately two years after recruitment commenced
Feasibility participant eligibility	eligibility rates (proportion of enrolled participants found eligible)	throughout the trial; approximately two years after recruitment commenced
Feasibility consents	number of participants consenting to study participation and reasons for refusals	throughout the trial; approximately two years after recruitment commenced
Feasibility retention	retention rate (i.e., number and proportion of participants who attend t1 assessment and completeness of data at t1)	throughout the trial; approximately two years after recruitment commenced
Feasibility adherence	attendance rates and dose of intervention (i.e., number of sessions delivered within six months)	throughout the trial; approximately two years after recruitment commenced
Feasibility data attrition	data attrition (proportion of outcome data not obtained)	throughout the trial; approximately two years after recruitment commenced
Acceptability participants	- drop-out rate (i.e., number of withdrawals)	throughout the trial; approximately two years after recruitment commenced
Acceptability and trial safety	- number of adverse and serious adverse events that are considered adverse reactions to the intervention	throughout the trial; approximately two years after recruitment commenced
Treatment satisfaction participants	- participant satisfaction with treatment and personal outcomes (post-intervention questionnaire)	throughout the trial; approximately two years after recruitment commenced
Treatment satisfaction therapists	- therapist satisfaction (post-intervention questionnaire therapist version)	throughout the trial; approximately two years after recruitment commenced

Collaborators and Investigators

• Sponsor: University of Hamburg-Eppendorf
• Investigators: Principal Investigator: Tania M Lincoln, Prof. Dr., Universität Hamburg

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): January 31, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Amotivation; Avolition; Anhedonia; Asociality
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: DRKS00018083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: only upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No