SchizophreniaSwitchNCT04325100
Intervention Targeting Motivational Negative Symptoms
A study testing Switch - Individual sessions and Switch - Group programme in people with Schizophrenia and Schizo Affective Disorder, run by University of Liege at 1 site in Belgium.
Trial summary
This study aims to investigate the effects of the Switch intervention on motivation and associated processes and explore the dynamics between the processes. A single case approach is followed, with a pre-post and follow-up assessment design, and continuous ambulatory assessments (experience sampling method (ESM) and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizo Affective Disorder, Bipolar Disorder
- What is being tested?
- Switch - Individual sessions and Switch - Group programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Apr 2019to 27 Feb 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic and Statistical Manual-V (DSM-V) criteria for schizophrenia, schizoaffective, bipolar or major depressive disorder (American Psychiatric Association, 2013).
- Good understanding of French.
Who cannot join
- Presenting an unstable clinical picture;
- Evidence of a significant change in medication within one month prior to baseline assessment;
- Having a history of severe brain trauma or epilepsy;
- Comorbid intellectual disability;
- Moderate or severe substance use disorder other than tobacco (according to the DSM-V; i.e., showing 4 or more symptoms).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of an Intervention Targeting Motivational Negative Symptoms: Switch Protocol 2
This study aims to investigate the effects of the Switch intervention on motivation and associated processes and explore the dynamics between the processes.
A single case approach is followed, with a pre-post and follow-up assessment design, and continuous ambulatory assessments (experience sampling method (ESM) and step count).
Read the detailed description
Motivational negative symptoms hinder quality of life and daily functioning of individuals with schizophrenia spectrum, bipolar and major depressive disorders.
A recently developed intervention, Switch, has shown promising effects on negative symptoms and functional outcomes. Switch is based on a model that identifies various cognitive, behavioural and emotional processes related to motivation and goal-directed behaviours: pleasure anticipation, value-effort-probability computation, (dys)functional attitudes (e.g., discouraging thoughts, self-efficacy), planning, initiation, in-the-moment enjoyment, reminiscence. The intervention combines a person-centred and recovery approach with cognitive, behavioural and 3rd wave techniques to tackle the obstacles related to motivation and goal-directed behaviours (i.e., targetting the various cognitive, behavioural and emotional processes listed above). Thus, an important part of the intervention focuses on the person's strengths, needs, goals and values. Furthermore, various strategies (e.g., cognitive defusion, pleasure anticipation, problem solving, reminiscence) are used to encourage engagement in meaningful personal goals and values.
The Switch intervention is provided either in individual (one-hour sessions), or in a group setting (two-hour sessions), twice a week for around two months.
There are three types of evaluation: traditional assessment scales of motivational deficits, apathy, quality of life and daily functioning (pre, post and follow-up at 3 months); ambulatory assessment including ESM (i.e., daily questionnaires); actigraphy (step count).
The aims of this study is to evaluate the efficacy of Switch in two different settings (i.e., individual sessions and a group programme) on motivation/apathy and functional outcomes/quality of life. Furthermore, we wish to explore the effects of Switch on process related to motivation and goal-directed behaviours (e.g., pleasure anticipation, reminiscence, defeatist beliefs, activities' meaningfulness) and on activity (i.e., step count). Finally, we wish to evaluate the dynamics between the different cognitive, behavioural and emotional processes related to motivation and goal-directed behaviours.
- Being tested
- Switch - Individual sessions, Switch - Group programme
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Switch - Individual sessionsBehavioural
Participants follow the Switch intervention through individual sessions (1 hour, twice a week, for around 2 months).
Participants are provided with a folder which presents the rational for each strategy. Take-home assignments are given and stored in the same folder. Participants are also given small cards (that can fit in their wallet) containing the key elements of each strategy.
The intervention manual can be obtained from the main investigator (in French).
Switch - Group programmeBehavioural
Participants follow the Switch group programme (2 hours, twice a week, for around 2 months).
During the group sessions, a powerpoint presentation and different media are used to present the different parts of the motivation model. Participants learn the different strategies (e.g., cognitive defusion, pleasure anticipation, problem solving) through individual and group exercises.
Participants are provided with a folder which presents the rational for each strategy. Take-home assignments are given and stored in the same folder. Participants are also given small cards (that can fit in their wallet) containing the key elements of each strategy.
The intervention manual and the presentation material can be obtained from the main investigator (in French).
| Study group | Role | What they receive |
|---|---|---|
| Switch - i | Experimental | Individual sessions Receives: Behavioral: Switch - Individual sessions |
| Switch - g | Experimental | Group programme Receives: Behavioral: Switch - Group programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Negative Symptom Scale (BNSS)
There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).
Measured: Baseline
Brief Negative Symptom Scale (BNSS)
There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).
Measured: 2 months (post intervention)
Brief Negative Symptom Scale (BNSS)
There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).
Measured: 6 months (follow-up)
Lille Apathy Rating Scale (patient version) (LARS-p)
The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 ([-36; -22] = absence of apathy; [-21; -17] = tendency towards apathy; [-16; -10] = moderate apathy; [-9; 36] = severe apathy).
Measured: Baseline
Lille Apathy Rating Scale (patient version) (LARS-p)
The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 ([-36; -22] = absence of apathy; [-21; -17] = tendency towards apathy; [-16; -10] = moderate apathy; [-9; 36] = severe apathy).
Measured: 2 months (post-intervention)
Lille Apathy Rating Scale (informant version) (LARS-i)
The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 ([-36; -22] = absence of apathy; [-21; -17] = tendency towards apathy; [-16; -10] = moderate apathy; [-9; 36] = severe apathy).
Measured: 6 months (follow-up)
Schizophrenia - Quality of Life questionnaire
The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.
Measured: Baseline (month 0)
Schizophrenia - Quality of Life questionnaire
The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.
Measured: 2 months (post-intervention)
Schizophrenia - Quality of Life questionnaire
The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.
Measured: 6 months (follow-up)
Functional Remission of General Schizophrenia (FROGS)
The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.
Measured: Baseline
Functional Remission of General Schizophrenia (FROGS)
The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.
Measured: 2 months (post-intervention)
Functional Remission of General Schizophrenia (FROGS)
The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.
Measured: 6 months (follow-up)
Secondary outcomes (8)
Experience Sampling Method
Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).
Measured: Baseline (14 days): 5 triggers/day
Experience Sampling Method
Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).
Measured: Intervention phase (60 days): 3 triggers/day
Experience Sampling Method
Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).
Measured: Post-intervention (14 days): 5 triggers/day
Experience Sampling Method
Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).
Measured: Follow-up (14 days): 5 triggers/day
Step count
Daily step count (total per day) via an activity band.
Measured: Baseline (14 days): 5 triggers/day
Step count
Daily step count (total per day) via an activity band.
Measured: Intervention phase (60 days): 3 triggers/day
Step count
Daily step count (total per day) via an activity band.
Measured: Post-intervention (14 days): 5 triggers/day
Step count
Daily step count (total per day) via an activity band.
Measured: Follow-up (14 days): 5 triggers/day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start20 Apr 2019
- Primary completion6 Dec 2019
- Study completion27 Feb 2020
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 SchizophreniaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Responsible party
- Principal investigator, Thonon Bénédicte, University of Liege
- Investigators
- Frank Laroi, PhD, Study director, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325100
- Sponsor's protocol ID
- B707201629105
- Acronym
- Switch
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and analyses will be available from an online repository or from the principal investigator.
Publications
Thonon B, Van Aubel E, Lafit G, Della Libera C, Laroi F. Idiographic analyses of motivation and related processes in participants with schizophrenia following a therapeutic intervention for negative symptoms. BMC Psychiatry. 2020 Sep 25;20(1):464. doi: 10.1186/s12888-020-02824-5.
PubMed 32977798
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Intervention Targeting Motivational Negative Symptoms: Switch Protocol 2
- ClinicalTrials.gov ID
- NCT04325100
- Acronym / sponsor ID
- Switch / B707201629105
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Study start
- 20 Apr 2019 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 27 Mar 2020 (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 study aims to investigate the effects of the Switch intervention on motivation and associated processes and explore the dynamics between the processes.
A single case approach is followed, with a pre-post and follow-up assessment design, and continuous ambulatory assessments (experience sampling method (ESM) and step count).
Detailed description
Motivational negative symptoms hinder quality of life and daily functioning of individuals with schizophrenia spectrum, bipolar and major depressive disorders.
A recently developed intervention, Switch, has shown promising effects on negative symptoms and functional outcomes. Switch is based on a model that identifies various cognitive, behavioural and emotional processes related to motivation and goal-directed behaviours: pleasure anticipation, value-effort-probability computation, (dys)functional attitudes (e.g., discouraging thoughts, self-efficacy), planning, initiation, in-the-moment enjoyment, reminiscence. The intervention combines a person-centred and recovery approach with cognitive, behavioural and 3rd wave techniques to tackle the obstacles related to motivation and goal-directed behaviours (i.e., targetting the various cognitive, behavioural and emotional processes listed above). Thus, an important part of the intervention focuses on the person's strengths, needs, goals and values. Furthermore, various strategies (e.g., cognitive defusion, pleasure anticipation, problem solving, reminiscence) are used to encourage engagement in meaningful personal goals and values.
The Switch intervention is provided either in individual (one-hour sessions), or in a group setting (two-hour sessions), twice a week for around two months.
There are three types of evaluation: traditional assessment scales of motivational deficits, apathy, quality of life and daily functioning (pre, post and follow-up at 3 months); ambulatory assessment including ESM (i.e., daily questionnaires); actigraphy (step count).
The aims of this study is to evaluate the efficacy of Switch in two different settings (i.e., individual sessions and a group programme) on motivation/apathy and functional outcomes/quality of life. Furthermore, we wish to explore the effects of Switch on process related to motivation and goal-directed behaviours (e.g., pleasure anticipation, reminiscence, defeatist beliefs, activities' meaningfulness) and on activity (i.e., step count). Finally, we wish to evaluate the dynamics between the different cognitive, behavioural and emotional processes related to motivation and goal-directed behaviours.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Switch - i | Experimental | Behavioral: Switch - Individual sessionsIndividual sessions |
| Switch - g | Experimental | Behavioral: Switch - Group programmeGroup programme |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnostic and Statistical Manual-V (DSM-V) criteria for schizophrenia, schizoaffective, bipolar or major depressive disorder (American Psychiatric Association, 2013).
- Good understanding of French.
Key exclusion criteria (5 listed)
- Presenting an unstable clinical picture;
- Evidence of a significant change in medication within one month prior to baseline assessment;
- Having a history of severe brain trauma or epilepsy;
- Comorbid intellectual disability;
- Moderate or severe substance use disorder other than tobacco (according to the DSM-V; i.e., showing 4 or more 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 |
|---|---|---|
| Switch - Individual sessionsParticipants follow the Switch intervention through individual sessions (1 hour, twice a week, for around 2 months). Participants are provided with a folder which presents the rational for each strategy. Take-home assignments are given and stored in the same folder. Participants are also given small cards (that can fit in their wallet) containing the key elements of each strategy. The intervention manual can be obtained from the main investigator (in French). | Behavioural | Switch - i |
| Switch - Group programmeParticipants follow the Switch group programme (2 hours, twice a week, for around 2 months). During the group sessions, a powerpoint presentation and different media are used to present the different parts of the motivation model. Participants learn the different strategies (e.g., cognitive defusion, pleasure anticipation, problem solving) through individual and group exercises. Participants are provided with a folder which presents the rational for each strategy. Take-home assignments are given and stored in the same folder. Participants are also given small cards (that can fit in their wallet) containing the key elements of each strategy. The intervention manual and the presentation material can be obtained from the main investigator (in French). | Behavioural | Switch - g |
Primary outcome
Brief Negative Symptom Scale (BNSS)
Time frame: Baseline
There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).
Brief Negative Symptom Scale (BNSS)
Time frame: 2 months (post intervention)
There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).
Brief Negative Symptom Scale (BNSS)
Time frame: 6 months (follow-up)
There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).
Lille Apathy Rating Scale (patient version) (LARS-p)
Time frame: Baseline
The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 ([-36; -22] = absence of apathy; [-21; -17] = tendency towards apathy; [-16; -10] = moderate apathy; [-9; 36] = severe apathy).
Lille Apathy Rating Scale (patient version) (LARS-p)
Time frame: 2 months (post-intervention)
The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 ([-36; -22] = absence of apathy; [-21; -17] = tendency towards apathy; [-16; -10] = moderate apathy; [-9; 36] = severe apathy).
Lille Apathy Rating Scale (informant version) (LARS-i)
Time frame: 6 months (follow-up)
The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 ([-36; -22] = absence of apathy; [-21; -17] = tendency towards apathy; [-16; -10] = moderate apathy; [-9; 36] = severe apathy).
Schizophrenia - Quality of Life questionnaire
Time frame: Baseline (month 0)
The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.
Schizophrenia - Quality of Life questionnaire
Time frame: 2 months (post-intervention)
The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.
Schizophrenia - Quality of Life questionnaire
Time frame: 6 months (follow-up)
The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.
Functional Remission of General Schizophrenia (FROGS)
Time frame: Baseline
The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.
Functional Remission of General Schizophrenia (FROGS)
Time frame: 2 months (post-intervention)
The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.
Functional Remission of General Schizophrenia (FROGS)
Time frame: 6 months (follow-up)
The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.
8 secondary outcomes
Experience Sampling Method
Time frame: Baseline (14 days): 5 triggers/day
Experience Sampling Method
Time frame: Intervention phase (60 days): 3 triggers/day
Experience Sampling Method
Time frame: Post-intervention (14 days): 5 triggers/day
Experience Sampling Method
Time frame: Follow-up (14 days): 5 triggers/day
Step count
Time frame: Baseline (14 days): 5 triggers/day
Step count
Time frame: Intervention phase (60 days): 3 triggers/day
Step count
Time frame: Post-intervention (14 days): 5 triggers/day
Step count
Time frame: Follow-up (14 days): 5 triggers/day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Derived from this study: PubMed 32977798Thonon B, Van Aubel E, Lafit G, Della Libera C, Laroi F. Idiographic analyses of motivation and related processes in participants with schizophrenia following a therapeutic intervention for negative symptoms. BMC Psychiatry. 2020 Sep 25;20(1):464. doi: 10.1186/s12888-020-02824-5.
- Individual participant dataSharing planned: Yes. Data and analyses will be available from an online repository or from the principal investigator.
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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.
Frank Laroi, PhD study director
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Switch - Individual sessions and Switch - Group programme in people with Schizophrenia and Schizo Affective Disorder, run by University of Liege at 1 site in Belgium.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 27 Mar 2020. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Negative Symptom Scale (BNSS) (time frame: Baseline). The study lists 12 primary outcomes in all. 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 NCT04325100, 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 27 Mar 2020.