Psychiatric DisordersTORCHNCT07844798
TORCH - Transdiagnostic Observation of Risk Factors, Craving and Health Behaviours in Psychiatric Patients
An observational study of Psychiatric Disorders, run by Jacobs University Bremen gGmbH at 1 site in Germany.
Trial summary
Mental disorders are often accompanied by health-risk behaviours, psychiatric comorbidity, and reduced functioning. TORCH investigates transdiagnostic mechanisms underlying multiple health behaviour change in adult psychiatric patients, with a focus on nicotine dependence and smoking. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Disorders
- What is being tested?
- person-centred interventions
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2026to 31 Dec 2030
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study includes adults with nicotine dependence receiving inpatient or day-care psychiatric treatment at the Department of Psychiatry and Psychotherapy, Kreiskrankenhaus Prignitz. Eligibility requires informed consent and sufficient German language proficiency, with exclusion of individuals whose acute clinical condition or impaired decisional capacity would preclude participation.
Who may be able to join
- Participants must:
- be affected by nicotine dependence
- Be 18 years of age or older.
- Be currently receiving inpatient or day-care psychiatric treatment at the Department of Psychiatry and Psychotherapy, Kreiskrankenhaus Prignitz.
- Be capable of understanding study information and providing informed consent.
- Possess sufficient German language proficiency to complete assessments and interviews.
- Agree to participate voluntarily.
Who cannot join
- Participants will be excluded if they:
- Experience acute psychiatric symptoms that substantially impair informed consent capacity.
- Are acutely intoxicated or experiencing severe withdrawal symptoms at the time of recruitment.
- Demonstrate insufficient decisional capacity according to clinical assessment.
- Do not have adequate German language proficiency.
- Have any condition judged by the treating clinical team to render participation inappropriate or excessively burdensome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Mental disorders are often accompanied by health-risk behaviours, psychiatric comorbidity, and reduced functioning. TORCH investigates transdiagnostic mechanisms underlying multiple health behaviour change in adult psychiatric patients, with a focus on nicotine dependence and smoking. Based on the Compensatory Carry-Over Action Model (CCAM), the project examines self-efficacy, motivation, stress regulation, coping, and social support in relation to psychiatric symptoms and rehabilitation outcomes. Using a multimethod, naturalistic observational design, quantitative and qualitative data will be collected in inpatient and day-care psychiatry to identify mechanisms that support health behaviour change and rehabilitation.
Read the detailed description
Abstract
TORCH - Transdiagnostic Observation of Risk Factors, Craving and Health Behaviours in Psychiatric Patients
Mental disorders are frequently associated with health-risk behaviours, complex comorbidity profiles, and limitations in functional participation. However, transdiagnostic approaches systematically investigating the relationships between psychiatric comorbidity, multiple health behaviour change, and rehabilitation-related outcomes remain limited.
The TORCH project therefore investigates psychological, clinical, and behavioural mechanisms associated with health behaviours, behaviour change processes, and rehabilitation outcomes in adult psychiatric patients. The central research questions are: Which transdiagnostic factors influence multiple health behaviour changes, and how are these factors associated with psychiatric comorbidities, rehabilitation motivation, functional recovery, and social participation?
A particular focus is placed on nicotine dependence and smoking behaviour as an exemplary health behaviour and their interactions with other health-related behaviours. Based on the Compensatory Carry-Over Action Model (CCAM), the study examines the extent to which shared self-regulatory processes, including self-efficacy, motivation for change, stress regulation, coping strategies, and social support, contribute to multiple behaviour change processes. Furthermore, the study investigates how psychiatric comorbidities and symptom severity influence these mechanisms and rehabilitation-related outcomes.
The study is designed as a multimethod, naturalistic observational study conducted in an inpatient and day-care psychiatric setting. Adult patients receiving treatment at the Department of Psychiatry and Psychotherapy, Kreiskrankenhaus Prignitz, will be included. Quantitative data collection comprises standardized clinical interviews, self-report questionnaires, and non-invasive assessment procedures. Measures include nicotine dependence and craving, transdiagnostic mechanisms (including stress and coping measures), psychiatric symptom severity, and rehabilitation-related variables. In addition, qualitative data will be collected through semi-structured individual interviews, a World Café format, and open-ended questions to explore individual experiences, barriers, and resources related to multiple health behaviour changes and rehabilitation processes.
The study duration is approximately 18 months. During the first three months, study preparation, training of the research team, and implementation of study procedures will be conducted. This will be followed by a pilot phase to evaluate the feasibility of the assessment procedures, the comprehensibility of the instruments, and the implementation of the qualitative data collection procedures, with adaptations made where necessary. From month 4 to month 13, participant recruitment and quantitative as well as qualitative data collection will take place. Months 14 to 16 will focus on data preparation, statistical analyses, and qualitative analyses. The final two months will be dedicated to integrating the findings, scientific dissemination, and deriving clinical implications.
- Conditions
- Psychiatric Disorders
- Being tested
- person-centred interventions
- Keywords
- Tobacco Use Disorder, Smoking Cessation, Mental Disorders, Inpatients, Health Behavior, Psychiatric Rehabilitation
- Medical subject headings
- Mental Disorders, Tobacco Use Disorder, Smoking Cessation, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
person-centred interventionsBehavioural
The clinic treatment is a person-centred interventions that support smoking cessation, health promotion, rehabilitation participation, and long-term recovery among individuals with mental disorders.
| Study group | Role | What they receive |
|---|---|---|
| Patients from a psychiatric clinic at the Kreiskrankenhaus Prignitz | Not described Receives: Behavioral: person-centred interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS-15
Barratt Impulsiveness Scale (BIS) is measuring behavioral inhibition (On a scale of 1 to 4: 1-rarely/never, 2-occasionally, 3-often, 4-almost always/always).
Measured: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
FEVER
Fragebogen zur Erfassung der Veränderungsbereitschaft (FEVER) is measuring readiness to hange / change motivation. On a scale of 1 to 5: 1-not at all applicable, 2-rather not applicable, 3-don't know/undecided, 4-rather applicable, 5-fully applicable.
Measured: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
F-SozU K-14
F-SozU K-14 is a Social Support Questionnaire. On a scale of 1 to 5: 1-not applicable, 2-rather not applicable, 3-partly applicable, 4-applicable, 5-exactly applicable.
Measured: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
Fagerström Test
Fagerström Test is measuring smoking behavior. Higher values mean higher consumption.
Measured: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
Secondary outcomes (8)
SF12
SF12 is measuring functional status (description can be found here: Singh, A., Gnanalingham, K., Casey, A., \& Crockard, A. (2006). Quality of life assessment using the Short Form-12 (SF-12) questionnaire in patients with cervical spondylotic myelopathy: comparison with SF-36. Spine, 31(6), 639-643.).
Measured: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
BSI-18
BSI-18 Is a Brief-Symptom Inventory. On a scale of 1 to 4: 1-not at all, 2, 3, 4-very strongly.
Measured: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
BIP-Q
BIP-Q is measuring the illness perceptions. On a scale of 0 to 10: 0-no impairment at all, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10-very severe impairment.
Measured: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
PSS
PSS is measuring perceived stress. On a scale of 1 to 5: 1-never, 2-almost never, 3-sometimes, 4-quite often, 5-very often.
Measured: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
CHB-Q
CHB-Q (Compensatory Health Beliefs) is a subscale for substance use. On a scale of 1 to 5: 1-strongly disagree, 2, 3, 4, 5-strongly agree.
Measured: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
QSU-G
QSU-G is a questionnaire on Smoking Urges. On a scale of 1 to 7: 1-completely true, 2, 3, 4, 5, 6, 7-not true at all.
Measured: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
BDI2
Beck Depression Index.
Measured: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
CHQ
Compensatory Health Belief Questionnaire (Subscale Substance Use). On a scale of 1 to 5: 1-strongly disagree, 2, 3, 4, 5-strongly agree.
Measured: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacobs University Bremen gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Kreiskrankenhaus Prignitz gGmbH, Hamburg University of Applied Sciences
- Responsible party
- Principal investigator, Prof. Dr. Sonia Lippke, Jacobs University Bremen gGmbH
- Investigators
- Sonia Lippke, Dr., Study director, Constructor University Bremen gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844798
- Sponsor's protocol ID
- TORCH_1.0
- Acronym
- TORCH
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TORCH - Transdiagnostic Observation of Risk Factors, Craving and Health Behaviours in Psychiatric Patients
- ClinicalTrials.gov ID
- NCT07844798
- Acronym / sponsor ID
- TORCH / TORCH_1.0
- Conditions
- Psychiatric Disorders
- Keywords
- Tobacco Use Disorder, Smoking Cessation, Mental Disorders, Inpatients, Health Behavior, Psychiatric Rehabilitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Jacobs University Bremen gGmbHUniversity, hospital or other
- Collaborators
- Kreiskrankenhaus Prignitz gGmbH, Hamburg University of Applied Sciences
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 28 Sep 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.
Mental disorders are often accompanied by health-risk behaviours, psychiatric comorbidity, and reduced functioning. TORCH investigates transdiagnostic mechanisms underlying multiple health behaviour change in adult psychiatric patients, with a focus on nicotine dependence and smoking. Based on the Compensatory Carry-Over Action Model (CCAM), the project examines self-efficacy, motivation, stress regulation, coping, and social support in relation to psychiatric symptoms and rehabilitation outcomes. Using a multimethod, naturalistic observational design, quantitative and qualitative data will be collected in inpatient and day-care psychiatry to identify mechanisms that support health behaviour change and rehabilitation.
Detailed description
Abstract
TORCH - Transdiagnostic Observation of Risk Factors, Craving and Health Behaviours in Psychiatric Patients
Mental disorders are frequently associated with health-risk behaviours, complex comorbidity profiles, and limitations in functional participation. However, transdiagnostic approaches systematically investigating the relationships between psychiatric comorbidity, multiple health behaviour change, and rehabilitation-related outcomes remain limited.
The TORCH project therefore investigates psychological, clinical, and behavioural mechanisms associated with health behaviours, behaviour change processes, and rehabilitation outcomes in adult psychiatric patients. The central research questions are: Which transdiagnostic factors influence multiple health behaviour changes, and how are these factors associated with psychiatric comorbidities, rehabilitation motivation, functional recovery, and social participation?
A particular focus is placed on nicotine dependence and smoking behaviour as an exemplary health behaviour and their interactions with other health-related behaviours. Based on the Compensatory Carry-Over Action Model (CCAM), the study examines the extent to which shared self-regulatory processes, including self-efficacy, motivation for change, stress regulation, coping strategies, and social support, contribute to multiple behaviour change processes. Furthermore, the study investigates how psychiatric comorbidities and symptom severity influence these mechanisms and rehabilitation-related outcomes.
The study is designed as a multimethod, naturalistic observational study conducted in an inpatient and day-care psychiatric setting. Adult patients receiving treatment at the Department of Psychiatry and Psychotherapy, Kreiskrankenhaus Prignitz, will be included. Quantitative data collection comprises standardized clinical interviews, self-report questionnaires, and non-invasive assessment procedures. Measures include nicotine dependence and craving, transdiagnostic mechanisms (including stress and coping measures), psychiatric symptom severity, and rehabilitation-related variables. In addition, qualitative data will be collected through semi-structured individual interviews, a World Café format, and open-ended questions to explore individual experiences, barriers, and resources related to multiple health behaviour changes and rehabilitation processes.
The study duration is approximately 18 months. During the first three months, study preparation, training of the research team, and implementation of study procedures will be conducted. This will be followed by a pilot phase to evaluate the feasibility of the assessment procedures, the comprehensibility of the instruments, and the implementation of the qualitative data collection procedures, with adaptations made where necessary. From month 4 to month 13, participant recruitment and quantitative as well as qualitative data collection will take place. Months 14 to 16 will focus on data preparation, statistical analyses, and qualitative analyses. The final two months will be dedicated to integrating the findings, scientific dissemination, and deriving clinical implications.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients from a psychiatric clinic at the Kreiskrankenhaus Prignitz | – | Behavioral: person-centred interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes adults with nicotine dependence receiving inpatient or day-care psychiatric treatment at the Department of Psychiatry and Psychotherapy, Kreiskrankenhaus Prignitz. Eligibility requires informed consent and sufficient German language proficiency, with exclusion of individuals whose acute clinical condition or impaired decisional capacity would preclude participation.
Key inclusion criteria (7 listed)
- be affected by nicotine dependence
- Be 18 years of age or older.
- Be currently receiving inpatient or day-care psychiatric treatment at the Department of Psychiatry and Psychotherapy, Kreiskrankenhaus Prignitz.
- Be capable of understanding study information and providing informed consent.
- Possess sufficient German language proficiency to complete assessments and interviews.
Key exclusion criteria (6 listed)
- Experience acute psychiatric symptoms that substantially impair informed consent capacity.
- Are acutely intoxicated or experiencing severe withdrawal symptoms at the time of recruitment.
- Demonstrate insufficient decisional capacity according to clinical assessment.
- Do not have adequate German language proficiency.
- Have any condition judged by the treating clinical team to render participation inappropriate or excessively burdensome.
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 |
|---|---|---|
| person-centred interventionsThe clinic treatment is a person-centred interventions that support smoking cessation, health promotion, rehabilitation participation, and long-term recovery among individuals with mental disorders. | Behavioural | Patients from a psychiatric clinic at the Kreiskrankenhaus Prignitz |
Primary outcome
BIS-15
Time frame: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
Barratt Impulsiveness Scale (BIS) is measuring behavioral inhibition (On a scale of 1 to 4: 1-rarely/never, 2-occasionally, 3-often, 4-almost always/always).
FEVER
Time frame: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
Fragebogen zur Erfassung der Veränderungsbereitschaft (FEVER) is measuring readiness to hange / change motivation. On a scale of 1 to 5: 1-not at all applicable, 2-rather not applicable, 3-don't know/undecided, 4-rather applicable, 5-fully applicable.
F-SozU K-14
Time frame: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
F-SozU K-14 is a Social Support Questionnaire. On a scale of 1 to 5: 1-not applicable, 2-rather not applicable, 3-partly applicable, 4-applicable, 5-exactly applicable.
Fagerström Test
Time frame: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
Fagerström Test is measuring smoking behavior. Higher values mean higher consumption.
8 secondary outcomes
SF12
Time frame: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
BSI-18
Time frame: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
BIP-Q
Time frame: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
PSS
Time frame: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
CHB-Q
Time frame: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
QSU-G
Time frame: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
BDI2
Time frame: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
CHQ
Time frame: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).
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 28 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Sonia Lippke, Dr. study director
Constructor University Bremen gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorders, run by Jacobs University Bremen gGmbH 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 7 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 28 Sep 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 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?
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 Marc Warnecke, Dr. (+493876 30 - 3200, m.warnecke@krankenhaus-prignitz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BIS-15 (time frame: Timepoint 0 (baseline), Timepoint 1 (2-4 weeks later) and Timepoint 2 (approximately 1 month after discharge).). The study lists 4 primary outcomes in all. 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 28 Sep 2026.