Intervention Targeting Motivational Negative Symptoms

NCT ID: NCT04325100

Last Updated: 2020-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-20

Study Completion Date

2020-02-27

Brief Summary

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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

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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.

Conditions

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Schizophrenia Schizo Affective Disorder Bipolar Disorder Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

A blinding procedure was used for the evaluation of the Brief Negative Symptom Scale: interviews were recorded and each video or sound recording was evaluated at the end of the study by one (or two) independent evaluator who was unaware of the recordings' assessment time.

Study Groups

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Switch - g

Group programme

Group Type EXPERIMENTAL

Switch - Group programme

Intervention Type BEHAVIORAL

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).

Switch - i

Individual sessions

Group Type EXPERIMENTAL

Switch - Individual sessions

Intervention Type BEHAVIORAL

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).

Interventions

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Switch - Individual sessions

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).

Intervention Type BEHAVIORAL

Switch - Group programme

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnostic and Statistical Manual-V (DSM-V) criteria for schizophrenia, schizoaffective, bipolar or major depressive disorder (American Psychiatric Association, 2013).
* Good understanding of French.

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fonds National de la Recherche Scientifique

OTHER

Sponsor Role collaborator

University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Thonon Bénédicte

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank Laroi, PhD

Role: STUDY_DIRECTOR

University of Liege

Locations

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University of Liege

Liège, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 32977798 (View on PubMed)

Other Identifiers

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B707201629105

Identifier Type: -

Identifier Source: org_study_id

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