PsychosisGIFNCT05252039
Goals in Focus: CBT for Motivational Negative Symptoms of Psychosis
A study testing Goals in Focus in people with Psychosis and Schizophrenia, run by University of Hamburg-Eppendorf at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Psychosis, Schizophrenia, Negative Symptoms With Primary Psychotic Disorder
- What is being tested?
- Goals in Focus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2020to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Psychotherapeutische Hoschschulambulanz Universität Hamburg
Hamburg, 20146
Anne K Fladung, Dr., anne.fladung@uni-hamburg.de
Tania M Lincoln, Prof. Dr.
About this study
Official title: 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.
Read the 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.
- Being tested
- Goals in Focus
- Keywords
- Amotivation, Avolition, Anhedonia, Asociality
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goals in FocusBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Goals in Focus Therapy | Experimental | Participants in this arm will receive 24 weekly sessions with Goals in Focus therapy (GiF) over 6 months. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 6 months after baseline assessment
Secondary outcomes (6)
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
Measured: 6 months after baseline assessment
Role Functioning Scale (RFS)
Psychosocial Functioning across different domains of social roles
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 6 months after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Mar 2020
- Primary completion31 Jan 2024
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, controlled, parallel-group, two-armed
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Pillny, University of Hamburg-Eppendorf
- Investigators
- Tania M Lincoln, Prof. Dr., Principal investigator, Universität Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252039
- Sponsor's protocol ID
- DRKS00018083
- Acronym
- GIF
- Status last verified
- May 2024
- First submitted
- 28 Jan 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only upon request
Publications
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.
PubMed 37131247
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goals in Focus: CBT for Motivational Negative Symptoms of Psychosis - a Randomized-controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT05252039
- Acronym / sponsor ID
- GIF / DRKS00018083
- Keywords
- Amotivation, Avolition, Anhedonia, Asociality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, controlled, parallel-group, two-armed
| Arm | Type | Receives |
|---|---|---|
| Goals in Focus Therapy | Experimental | Behavioral: Goals in FocusParticipants in this arm will receive 24 weekly sessions with Goals in Focus therapy (GiF) over 6 months. |
| 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. |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goals in FocusGoals 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. | Behavioural | Goals in Focus Therapy |
Primary outcome
Brief Negative Symptoms Scale (BNSS) - 'motivation and pleasure factor' score
Time frame: 6 months after baseline assessment
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 secondary outcomes
Avolition, Asociality and Anhedonia
Time frame: 6 months after baseline assessment
Role Functioning Scale (RFS)
Time frame: 6 months after baseline assessment
Global Assessment of Functioning (GAF)
Time frame: 6 months after baseline assessment
Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Time frame: 6 months after baseline assessment
Calgary Depression Rating Scale for Schizophrenia (CDSS)
Time frame: 6 months after baseline assessment
Goal-pursuit within daily-life
Time frame: 6 months after baseline assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 37131247Schormann 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.
- Individual participant dataSharing planned: No. only upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania M Lincoln, Prof. Dr. principal investigator
Universität Hamburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goals in Focus in people with Psychosis and Schizophrenia, run by University of Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Pillny, Dr. (+4940428384023, matthias.pillny@uni-hamburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Negative Symptoms Scale (BNSS) - 'motivation and pleasure factor' score (time frame: 6 months after baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05252039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.