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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goals in Focus Therapy | Experimental | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthias Pillny, Dr. | Contact | +4940428384023 | matthias.pillny@uni-hamburg.de |
| Name | Affiliation | Role |
|---|---|---|
| Tania M Lincoln, Prof. Dr. | Universität Hamburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychotherapeutische Hoschschulambulanz Universität Hamburg | Recruiting | Hamburg | 20146 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37131247 | Derived | 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. |
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only upon request
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| D059445 | Anhedonia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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prospective, randomized, controlled, parallel-group, two-armed
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|
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 |
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 |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |