Mental DisordersNCT07735481
Promoting Recovery by Overcoming Self-stigma in Mental Health Disorders With a Narrative Enhancement and Cognitive Therapy (NECT) Group Intervention
A study testing Narrative Enhancement Cognitive Therapy in people with Mental Disorders and Substance Use Disorders, run by Louise Penzenstadler at 1 site in Switzerland.
Trial summary
This study will evaluate whether Narrative Enhancement and Cognitive Therapy (NECT) can promote recovery among adults living with severe mental health disorders, including substance use disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders, Substance Use Disorders
- What is being tested?
- Narrative Enhancement Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- DSM-5 psychiatric diagnosis within F10-F48, F60-F69, or F90, including substance use disorders
- Receiving outpatient or day-hospital treatment
- Diagnosed or in treatment for at least 12 months
- Clinically stable for at least 3 months, with stable pharmacological treatment during this period
- Clinical Global Impressions-Severity score below 6
Who cannot join
- Participation in another program likely to affect social functioning or self-stigma, such as social cognitive remediation or social skills training
- Acute psychiatric episode with a Clinical Global Impressions-Severity score above 6
- Medical emergency or immediate life-threatening situation at inclusion
- Unable to provide informed consent
- Comorbid intellectual disability
- Receiving care under constraint or deprived of liberty by judicial order Insufficient ability to speak and read French
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Geneva University Hospital
Geneva, Canton of Geneva, 1205
Louise Penzenstadler, MD, +41223725750, louise.penzenstadler@hug.ch
About this study
Official title: Promoting Recovery by Overcoming Self-stigma in Mental Health Disorders With a Narrative Enhancement and Cognitive Therapy (NECT) Group Intervention - A Randomized Controlled Trial and Qualitative Study
This study will evaluate whether Narrative Enhancement and Cognitive Therapy (NECT) can promote recovery among adults living with severe mental health disorders, including substance use disorders. NECT is a structured group intervention that combines education about stigma, cognitive techniques to challenge internalized negative beliefs, and narrative exercises that help participants develop a broader identity beyond their diagnosis.
Approximately 106 adults receiving outpatient or day-hospital psychiatric care at Geneva University Hospitals will be randomly assigned to receive either usual care plus 12 weekly NECT sessions or usual care plus 12 comparison group sessions that do not specifically address self-stigma or recovery. The study will examine whether NECT improves recovery after the intervention and whether any benefits are maintained over time.
Read the detailed description
Self-stigma occurs when people internalize negative societal stereotypes about mental illness. It can contribute to shame, reduced self-esteem, hopelessness, social withdrawal, lower treatment engagement, and difficulties pursuing personal goals. Although recovery-oriented mental health care increasingly emphasizes empowerment, resilience, social inclusion, and quality of life, interventions specifically targeting self-stigma are not yet routinely available. This is particularly relevant for people with substance use disorders, who may experience strong moral judgment and stigmatizing attitudes.
Narrative Enhancement and Cognitive Therapy is a manualized, recovery-oriented group intervention developed to reduce self-stigma. The programme combines psychoeducation about stigma and common misconceptions, cognitive restructuring of negative beliefs about oneself, and narrative exercises in which participants reflect on and share personal experiences. Its purpose is to help participants develop a more integrated understanding of themselves that is not defined solely by mental illness. Previous studies have reported beneficial effects in people with psychotic disorders, but evidence remains limited for other psychiatric populations and for people with substance use disorders. The French-language programme has not yet been evaluated in routine clinical practice.
The study will use a prospective, multicentre, randomized controlled design with an additional qualitative component. Approximately 106 adults with psychiatric disorders will be recruited from three specialized outpatient or day-hospital settings within the Department of Psychiatry at Geneva University Hospitals. Participants will be randomly allocated in a 1:1 ratio to an intervention or control condition. Randomization will be stratified by participating centre.
Participants assigned to the intervention condition will continue their usual psychiatric care and attend 12 weekly NECT group sessions. Participants assigned to the control condition will continue their usual care and attend 12 weekly group sessions that do not include specific psychotherapeutic or psychoeducational content addressing self-stigma or recovery. The comparison sessions may focus, for example, on participants' weekly activities.
NECT will be delivered in groups of approximately eight participants. Each 90-minute session will be facilitated by two trained co-facilitators, including a mental health professional and a peer practitioner. The programme includes an introductory session, psychoeducation, cognitive restructuring, narrative enhancement, and a concluding session. Participants who miss a session may be offered an individual make-up session to review the content and reduce the risk of discontinuing the programme.
The main objective is to determine whether participation in NECT improves personal recovery compared with the control condition. The study will also examine whether any changes are maintained approximately six months after the intervention and whether NECT influences self-stigma, empowerment, quality of life, self-esteem, self-compassion, psychological flexibility, psychiatric symptoms, and substance use.
In addition to the quantitative evaluation, participants who receive NECT may take part in semi-structured interviews after the intervention. These interviews will explore how participants experienced the programme, what they found useful, and how changes in self-stigma may contribute to recovery. The qualitative findings will complement the quantitative results and help inform the possible future implementation of NECT in routine psychiatric and addiction services.
- Conditions
- Mental Disorders, Substance Use Disorders
- Being tested
- Narrative Enhancement Cognitive Therapy, Control Group Sessions
- Keywords
- Narrative Enhancement and Cognitive Therapy, Self stigma, Recovery, Substance use disorders, Transdiagnostic group intervention
- Medical subject headings
- Mental Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Enhancement Cognitive TherapyBehavioural
NECT is a manualized group intervention comprising 12 weekly 90-minute sessions delivered to groups of approximately eight participants. It combines psychoeducation about stigma and self-stigma, cognitive restructuring of internalized negative beliefs, and narrative exercises that help participants develop a more integrated identity beyond mental illness. Sessions are co-facilitated by a trained mental health professional and a peer practitioner. Individual make-up sessions may be offered for missed sessions.
Control Group SessionsBehavioural
Twelve weekly group sessions in which participants discuss topics such as their weekly activities, without specific psychotherapeutic or psychoeducational content targeting self-stigma or recovery. Treatment as usual continues throughout.
| Study group | Role | What they receive |
|---|---|---|
| NECT | Experimental | Treatment as usual plus 12 weekly 90-minute NECT group sessions combining psychoeducation, cognitive restructuring, and narrative exercises to reduce self-stigma and support recovery. Receives: Behavioral: Narrative Enhancement Cognitive Therapy |
| Control Group | Active comparator | Treatment as usual plus 12 weekly group sessions without specific psychotherapeutic or psychoeducational content targeting self-stigma or recovery Receives: Behavioral: Control Group Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in personal recovery measured by the Recovery Assessment Scale
Personal recovery will be assessed using the Recovery Assessment Scale (RAS). The total score ranges up to 205, with higher scores indicating greater recovery. An increase of at least 14 points is considered clinically meaningful.
Measured: Baseline to post-intervention, approximately 12 weeks.
Secondary outcomes (8)
Change in personal recovery at follow-up
Personal recovery measured with the Recovery Assessment Scale. The total score ranges up to 205, with higher scores indicating greater recovery. An increase of at least 14 points is considered clinically meaningful.
Measured: Baseline to approximately 6 months after the intervention.
Change in self-stigma
Self-stigma measured with the 29-item Internalized Stigma of Mental Illness Scale. Items are rated from 1 to 4 and combined into a mean total score ranging from 29 to 116. The stigma-resistance items are reverse-scored. Higher scores indicate greater internalized stigma and therefore a worse outcome.
Measured: Baseline, post-intervention, and approximately 6 months after the intervention.
Change in empowerment
Sense of empowerment measured with the 28-item Empowerment Scale. an overall mean score will be calculated, ranging from 28 to 112. Higher scores indicate greater perceived empowerment and therefore a better outcome.
Measured: Baseline, post-intervention, and approximately 6 months after the intervention.
Change in quality of life
Subjective quality of life measured with the 26-item WHO Quality of Life-BREF. Scores will be calculated separately for the physical health, psychological health, social relationships, and environment domains and transformed to a scale ranging from 0 to 100. Higher scores indicate better quality of life and therefore a better outcome.
Measured: Baseline, post-intervention, and approximately 6 months after the intervention.
Change in self-compassion
Self-compassion measured with the 26-item Self-Compassion Scale. The total score is ranging from 26 to 130. Higher scores indicate greater self-compassion and therefore a better outcome.
Measured: Baseline, post-intervention, and approximately 6 months after the intervention.
Change in psychological flexibility
Psychological flexibility measured with the 10-item Acceptance and Action Questionnaire-II. Items are rated from 1 to 7 and summed to produce a total score ranging from 10 to 70. Higher scores indicate greater psychological inflexibility and experiential avoidance and therefore a worse outcome.
Measured: Baseline, post-intervention, and approximately 6 months after the intervention.
Change in psychiatric symptoms
Psychiatric symptoms measured with the 23-item DSM-5 Cross-Cutting Symptom Measure, Levels 1. It assesses 13 psychiatric symptom domains. Each item is rated from 0 to 4, and the highest item score within each domain is used as the domain score. Each domain score therefore ranges from 0 to 4. Higher scores indicate greater symptom frequency or severity and therefore a worse outcome. There is no single total score for this measure. The scores should be reported by domain.
Measured: Baseline, post-intervention, and approximately 6 months after the intervention.
Change in substance use
Substance use will be assessed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Level 2-Substance Use. Each substance-specific item is rated from 0 to 4, where 0 indicates no use and 4 indicates use nearly every day during the previous two weeks. Higher item scores indicate more frequent substance use and therefore a worse outcome. Individual substance items will be interpreted separately rather than as a single overall scale score.
Measured: Baseline, post-intervention at approximately 12 weeks, and 6 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies 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
- Two-arm, multicenter, randomized controlled trial with 1:1 allocation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louise Penzenstadler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Louise Penzenstadler, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735481
- Sponsor's protocol ID
- in preparation
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding the sharing of de-identified individual participant data has not yet been made. Data sharing will depend on applicable ethical and data-protection requirements, participant consent, and approval by the study investigators and relevant institutions.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Recovery by Overcoming Self-stigma in Mental Health Disorders With a Narrative Enhancement and Cognitive Therapy (NECT) Group Intervention - A Randomized Controlled Trial and Qualitative Study
- ClinicalTrials.gov ID
- NCT07735481
- Acronym / sponsor ID
- in preparation
- Conditions
- Mental Disorders, Substance Use Disorders
- Keywords
- Narrative Enhancement and Cognitive Therapy, Self stigma, Recovery, Substance use disorders, Transdiagnostic group intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Louise PenzenstadlerUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 30 Jul 2026 (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 will evaluate whether Narrative Enhancement and Cognitive Therapy (NECT) can promote recovery among adults living with severe mental health disorders, including substance use disorders. NECT is a structured group intervention that combines education about stigma, cognitive techniques to challenge internalized negative beliefs, and narrative exercises that help participants develop a broader identity beyond their diagnosis.
Approximately 106 adults receiving outpatient or day-hospital psychiatric care at Geneva University Hospitals will be randomly assigned to receive either usual care plus 12 weekly NECT sessions or usual care plus 12 comparison group sessions that do not specifically address self-stigma or recovery. The study will examine whether NECT improves recovery after the intervention and whether any benefits are maintained over time.
Detailed description
Self-stigma occurs when people internalize negative societal stereotypes about mental illness. It can contribute to shame, reduced self-esteem, hopelessness, social withdrawal, lower treatment engagement, and difficulties pursuing personal goals. Although recovery-oriented mental health care increasingly emphasizes empowerment, resilience, social inclusion, and quality of life, interventions specifically targeting self-stigma are not yet routinely available. This is particularly relevant for people with substance use disorders, who may experience strong moral judgment and stigmatizing attitudes.
Narrative Enhancement and Cognitive Therapy is a manualized, recovery-oriented group intervention developed to reduce self-stigma. The programme combines psychoeducation about stigma and common misconceptions, cognitive restructuring of negative beliefs about oneself, and narrative exercises in which participants reflect on and share personal experiences. Its purpose is to help participants develop a more integrated understanding of themselves that is not defined solely by mental illness. Previous studies have reported beneficial effects in people with psychotic disorders, but evidence remains limited for other psychiatric populations and for people with substance use disorders. The French-language programme has not yet been evaluated in routine clinical practice.
The study will use a prospective, multicentre, randomized controlled design with an additional qualitative component. Approximately 106 adults with psychiatric disorders will be recruited from three specialized outpatient or day-hospital settings within the Department of Psychiatry at Geneva University Hospitals. Participants will be randomly allocated in a 1:1 ratio to an intervention or control condition. Randomization will be stratified by participating centre.
Participants assigned to the intervention condition will continue their usual psychiatric care and attend 12 weekly NECT group sessions. Participants assigned to the control condition will continue their usual care and attend 12 weekly group sessions that do not include specific psychotherapeutic or psychoeducational content addressing self-stigma or recovery. The comparison sessions may focus, for example, on participants' weekly activities.
NECT will be delivered in groups of approximately eight participants. Each 90-minute session will be facilitated by two trained co-facilitators, including a mental health professional and a peer practitioner. The programme includes an introductory session, psychoeducation, cognitive restructuring, narrative enhancement, and a concluding session. Participants who miss a session may be offered an individual make-up session to review the content and reduce the risk of discontinuing the programme.
The main objective is to determine whether participation in NECT improves personal recovery compared with the control condition. The study will also examine whether any changes are maintained approximately six months after the intervention and whether NECT influences self-stigma, empowerment, quality of life, self-esteem, self-compassion, psychological flexibility, psychiatric symptoms, and substance use.
In addition to the quantitative evaluation, participants who receive NECT may take part in semi-structured interviews after the intervention. These interviews will explore how participants experienced the programme, what they found useful, and how changes in self-stigma may contribute to recovery. The qualitative findings will complement the quantitative results and help inform the possible future implementation of NECT in routine psychiatric and addiction services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two-arm, multicenter, randomized controlled trial with 1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| NECT | Experimental | Behavioral: Narrative Enhancement Cognitive TherapyTreatment as usual plus 12 weekly 90-minute NECT group sessions combining psychoeducation, cognitive restructuring, and narrative exercises to reduce self-stigma and support recovery. |
| Control Group | Active comparator | Behavioral: Control Group SessionsTreatment as usual plus 12 weekly group sessions without specific psychotherapeutic or psychoeducational content targeting self-stigma or recovery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent
- DSM-5 psychiatric diagnosis within F10-F48, F60-F69, or F90, including substance use disorders
- Receiving outpatient or day-hospital treatment
- Diagnosed or in treatment for at least 12 months
- Clinically stable for at least 3 months, with stable pharmacological treatment during this period
Key exclusion criteria (6 listed)
- Participation in another program likely to affect social functioning or self-stigma, such as social cognitive remediation or social skills training
- Acute psychiatric episode with a Clinical Global Impressions-Severity score above 6
- Medical emergency or immediate life-threatening situation at inclusion
- Unable to provide informed consent
- Comorbid intellectual disability
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 |
|---|---|---|
| Narrative Enhancement Cognitive TherapyNECT is a manualized group intervention comprising 12 weekly 90-minute sessions delivered to groups of approximately eight participants. It combines psychoeducation about stigma and self-stigma, cognitive restructuring of internalized negative beliefs, and narrative exercises that help participants develop a more integrated identity beyond mental illness. Sessions are co-facilitated by a trained mental health professional and a peer practitioner. Individual make-up sessions may be offered for missed sessions. | Behavioural | NECT |
| Control Group SessionsTwelve weekly group sessions in which participants discuss topics such as their weekly activities, without specific psychotherapeutic or psychoeducational content targeting self-stigma or recovery. Treatment as usual continues throughout. | Behavioural | Control Group |
Primary outcome
Change in personal recovery measured by the Recovery Assessment Scale
Time frame: Baseline to post-intervention, approximately 12 weeks.
Personal recovery will be assessed using the Recovery Assessment Scale (RAS). The total score ranges up to 205, with higher scores indicating greater recovery. An increase of at least 14 points is considered clinically meaningful.
8 secondary outcomes
Change in personal recovery at follow-up
Time frame: Baseline to approximately 6 months after the intervention.
Change in self-stigma
Time frame: Baseline, post-intervention, and approximately 6 months after the intervention.
Change in empowerment
Time frame: Baseline, post-intervention, and approximately 6 months after the intervention.
Change in quality of life
Time frame: Baseline, post-intervention, and approximately 6 months after the intervention.
Change in self-compassion
Time frame: Baseline, post-intervention, and approximately 6 months after the intervention.
Change in psychological flexibility
Time frame: Baseline, post-intervention, and approximately 6 months after the intervention.
Change in psychiatric symptoms
Time frame: Baseline, post-intervention, and approximately 6 months after the intervention.
Change in substance use
Time frame: Baseline, post-intervention at approximately 12 weeks, and 6 months after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Undecided. A decision regarding the sharing of de-identified individual participant data has not yet been made. Data sharing will depend on applicable ethical and data-protection requirements, participant consent, and approval by the study investigators and relevant institutions.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Enhancement Cognitive Therapy in people with Mental Disorders and Substance Use Disorders, run by Louise Penzenstadler at 1 site in Switzerland.
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 6 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: opening soon, as of the sponsor's last update on 5 Aug 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise Penzenstadéer, MD (+41223725750, louise.penzenstadler@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in personal recovery measured by the Recovery Assessment Scale (time frame: Baseline to post-intervention, approximately 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.