Psychological DistressNCT05030909
Feasibility Study of a Group Intervention for Youth Wellbeing
A study testing transdiagnostic group treatment in people with Psychological Distress and Trauma, Psychological, run by University of Otago at 1 site in New Zealand.
Trial summary
Psychological distress, anxiety and depression are common in adolescence, and even more so following traumatic events. On Friday 15 March 2019, two mosques in Ōtautahi, Christchurch were targeted in an act of terrorism, resulting in 71 people being injured and 51 people being shot dead. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Trauma, Psychological, Emotional Problem
- What is being tested?
- transdiagnostic group treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNew Zealand
- Study dates
- 10 Apr 2024to 7 Sep 2025
- 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 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All high school enrolled teenagers
- English speaking
- Participants do not need to identify as Muslim but will be made aware that the protocol incorporates elements of the Muslim faith.
Who cannot join
- active psychosis,
- severe substance use,
- intellectual disability
- non-English speaking young people.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Department of Psychological Medicine, University of Otago, Christchurch
Christchurch, Canterbury, 8140
About this study
Official title: An Integrated Transdiagnostic Protocol to Support Wellbeing in Adolescents From a Community Impacted by March 15 Attacks: a Randomized Controlled Trial
Psychological distress, anxiety and depression are common in adolescence, and even more so following traumatic events. On Friday 15 March 2019, two mosques in Ōtautahi, Christchurch were targeted in an act of terrorism, resulting in 71 people being injured and 51 people being shot dead. This has had widespread repercussions in the Muslim and wider community in Christchurch and New Zealand. Uptake of a response pathway set up by community and district health board groups has been low despite reports of high levels of distress in the adolescent population.
The proposed study offers a transdiagnostic group treatment approach (ie. Targeting a broad range of emotional difficulties) for teenagers from a community impacted by the March 15th shootings, incorporating well-evidenced transdiagnostic treatment principles into an Islamic Psychology framework to address the local population's need. We will determine the feasibility and effectiveness of this approach in increasing wellbeing in teenagers. We will run gender-specific treatment groups (8 participants in each group) recruited from the community, with one individual session (for information and consent) and 6 group sessions. We will measure symptoms of emotional difficulties, trauma symptoms and functioning at baseline, end of treatment and at 3 months follow-up. In addition, we will check in weekly with participants to monitor for any increased distress. We will also measure parental distress to explore whether an intervention for adolescents has an impact on parental wellbeing.
Read the detailed description
Background and rationale On Friday 15 March 2019, two mosques in Christchurch were targeted in an act of terrorism. A white supremacist shooter attacked approximately 300 people, resulting in 51 deaths and 71 further people injured. The attack has been described as an attack on the Muslim faith and those affected by the event have expressed the importance of spiritual support as well as mental health support in the wake of the tragedy. Research into the effects of the attacks on adults in the Muslim community has identified significant concern over young people's mental health 1. A comprehensive framework of community support for children and adolescents was established involving collaboration between schools, primary care, community NGOs and secondary mental health services however the uptake of these services has been lower than expected despite reports of a growing need for support in these age groups1. Stigma regarding mental illness and distress has been identified as a major barrier to accessing supports.
Psychological distress, anxiety and depression are common in adolescence with substantial personal, societal and economic costs2,3. Transdiagnostic interventions (interventions which can be used across different mental health conditions) have gained support in treatment for adults, and evidence is emerging for their use in adolescent populations4-7. Evidence-informed holistic approaches to supporting wellbeing and mental health place less emphasis on pathology and can be more strengths-based with a focus on values. These approaches may appeal to young people and their families concerned about stigma and labelling 'difficulties' as 'disorders'.
Spiritually integrated psychotherapy has a growing evidence base and is associated with treatment adherence and therapeutic outcome8. An Islamic Psychology approach recognises spirituality as integral to the human experience, with models of Islamic psychotherapy gaining traction in recent years9. A model of traditionally integrated Islamic psychotherapy incorporates five interconnected elements; Áql (cognition), nafs (behavioural inclination), ruh (spirit), ihsas (emotion) and qalb (heart)10.
Holistic approaches to health are not new in New Zealand. Maori models of health are increasingly being adopted such as the Te Whare Tapa Wha model, emphasizing four cornerstones of Maori health11. These include Taha tinana (physical health), Taha wairua (spiritual health), Taha whanau (family health) and Taha hinengaro (mental health).
The proposed study offers a novel treatment approach for teenagers affected by the shootings, incorporating well-evidenced transdiagnostic treatment principles into an Islamic psychology framework to address the local population's need. It will assess the likely size of treatment effect on reported emotional difficulties and post-traumatic stress symptoms, and the feasibility of this approach in supporting wellbeing. We also will measure parental distress (mental health difficulties and physical symptoms) to explore whether an intervention for adolescents has an impact on parental wellbeing. The programme will also provide the opportunity to screen and identify individuals who may benefit from referral to further supports.
- Being tested
- transdiagnostic group treatment
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transdiagnostic group treatmentBehavioural
The individual and group sessions will integrate core principles from Motivational interviewing (provide information, address barriers), Cognitive Behavioural Therapy (psychoeducation regarding emotions, enhancing emotional awareness, cognitive restructuring, behavioural experiments, relaxation) , Acceptance Commitment Therapy (mindfulness, grounding, emotional and body awareness, enhancing cognitive flexibility), and aspects of Islamic psychology.
| Study group | Role | What they receive |
|---|---|---|
| transdiagnostic group protocol | Experimental | The study will run two gender-specific treatment groups (8 participants each) recruited from the community, with one individual session (for information, consent and initial data collection) and 6 group sessions. Both groups will receive the same intervention. A second round of recruitment will run later with anticipated n of 32 in the experimental arm. Receives: Behavioral: transdiagnostic group treatment |
| Waitlist control | Other | At both recruitment rounds, we will recruit 16 young people to receive the same intervention at a later stage. We will ask them to complete data collection at the same timepoints as the experimental arm participants to compare intervention effect size but will offer them the intervention afterwards so they still have access to the group. Data collected from them in the group will be used to assess feasibility and acceptability but not treatment effect size comparison. Receives: Behavioral: transdiagnostic group treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total problems score
change in total problems score in Strengths and Difficulties Questionnaire (SDQ), self report and parent report.Scored 0-40 with higher scores indicating more problems.
Measured: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Emotional problems subscore
change in emotional problems subscore in Strengths and Difficulties Questionnaire (SDQ), self report and parent report. Score ranges 0-10 with higher scores indicating more emotional difficulties.
Measured: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Trauma symptoms
change in total score of Child Revised Impact of Event Score (8 item ) (CRIES-8) by self report, score range 0-40, higher scores indicate more PTSD symptoms.
Measured: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Somatic Symptom burden
change in somatic symptoms measured using Somatic Symptom Scale (8-item) (SSS-8) self report questionnaire by participants and parents. 5 point Likert scale gives a total score with range 0-32. Cutoff scores identify individuals with low (4-7), medium (8-11), high(12-15), and very high (16-32)somatic symptom burden.
Measured: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Functional assessment
change in function measured using Children's Global Assessment Scale (CGAS) by clinician. Clinicians give a single global score ranging from 0-100 with higher scores indicating better functioning.
Measured: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Time to recruitment
Time in weeks required to enrol 16 participants and hold initial individual session.
Measured: Measured before first group session at week 3.
Implementation
measured by use of fidelity scale to rate adherence to planned session content
Measured: Each session will be audio-recorded and scored (at individual session at week 1, weekly group sessions weeks 3- 7, and 3 month follow up/week 19)
Psychological flexibility
change in score on Acceptance and Action Questionnaire (AAQ-2), self
Measured: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Awareness of experience
change in score on Awareness Indicator (AI), new measure asking about awareness of thoughts(aql), body sensations, feelings/emotions, and spiritual heart (qalb and ruh)
Measured: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Secondary outcomes (7)
Parental distress
change in distress measured using Kessler 10 (K-10) psychological questionnaire by parental self report and measured to identify whether further referrals are required. 5 point Likert scale gives a score of 10-50 with higher scores indicating higher distress. Scores 20-24 indicate likely mild mental disorder, 25-29 indicates likely moderate mental disorder and scores 30 and above indicate likely severe mental disorder. Referral will be offered for any scores over 20.
Measured: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Suicidal risk
measured using Ask Suicide-screening questionnaire by self-report to assess whether further intervention is necessary and for any deterioration in mental state.It has 4 screening questions and a positive response to any of the 4 questions indicates a positive screen.
Measured: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Participant Wellbeing
measured using the Child Outcome Rating Scale (CORS) by self report to check for any deterioration in wellbeing. The CORS is a 4 item visual analogue scale to give a quantitative measure of individual wellbeing, relationships, social role and overall wellbeing.
Measured: at each individual (week 1) and group session (weeks 3-7) and at 3 month follow up (week 19).
Personality traits
change in specific traits of Extroversion, Neuroticism, Openness, Conscientiousness Agreeableness measured using the Big Five Inventory - 10 item (BFI-10) measure by self report. 10 questions are answered on a 5 point Likert scale giving a score for each personality trait.
Measured: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Attendance rates
measured by recording attendance.
Measured: recorded at each weekly group session (weeks 3-7) and data collection point (at individual session at week 1, final group session at 7 weeks and 3 month follow up/week 19).
Participant experience/acceptability
measured by Child Session Rating Scale (CSRS) which uses a 4 item visual analogue scale to give a quantitative measure of acceptability. Qualitative feedback will also be collected.
Measured: After each individual (week 1) and weekly group session (weeks 3-7). A brief qualitative interview with each participant at the final group session at week 7 will also ask for their experience of the group.
Retention
measured by recording retention/drop-out rates.
Measured: At final data collection point at week 19.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start10 Apr 2024
- Primary completion7 Sep 2025
- Study completion7 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Trial Design This is a randomised control trial with a sequential waitlist control design to measure treatment effect sizes on primary and secondary outcomes of participant and parental wellbeing. We also will assess the methods of delivery, face validity and acceptability of treatment. Teenagers (aged 12-19) from the community will be recruited and allocated randomly to either two gender-specific groups to receive the same intervention over 6 weeks or to a comparison group who will be offered the intervention later. This balances the need for control groups while also widening access to the intervention for recruited participants. The study will be community-based in one site (Ōtautahi, Christchurch, New Zealand), with an emphasis on widening access to mental health supports in a minority community by maintaining cultural sensitivity and reducing stigma associated with mental illness.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Otago
- Sponsor type
- University, hospital or other
- Collaborators
- Canterbury Medical Research Foundation
- Responsible party
- Sponsor
- Investigators
- Caroline Bell, MD, Study director, University of Otago, Christchurch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030909
- Sponsor's protocol ID
- RO#21178
- Status last verified
- May 2026
- First submitted
- 9 Aug 2021
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Transdiagnostic Protocol to Support Wellbeing in Adolescents From a Community Impacted by March 15 Attacks: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05030909
- Acronym / sponsor ID
- RO#21178
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of OtagoUniversity, hospital or other
- Collaborators
- Canterbury Medical Research Foundation
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 7 Sep 2025 (actual)
- Study completion
- 7 Sep 2025 (actual)
- First posted
- 1 Sep 2021 (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.
Psychological distress, anxiety and depression are common in adolescence, and even more so following traumatic events. On Friday 15 March 2019, two mosques in Ōtautahi, Christchurch were targeted in an act of terrorism, resulting in 71 people being injured and 51 people being shot dead. This has had widespread repercussions in the Muslim and wider community in Christchurch and New Zealand. Uptake of a response pathway set up by community and district health board groups has been low despite reports of high levels of distress in the adolescent population.
The proposed study offers a transdiagnostic group treatment approach (ie. Targeting a broad range of emotional difficulties) for teenagers from a community impacted by the March 15th shootings, incorporating well-evidenced transdiagnostic treatment principles into an Islamic Psychology framework to address the local population's need. We will determine the feasibility and effectiveness of this approach in increasing wellbeing in teenagers. We will run gender-specific treatment groups (8 participants in each group) recruited from the community, with one individual session (for information and consent) and 6 group sessions. We will measure symptoms of emotional difficulties, trauma symptoms and functioning at baseline, end of treatment and at 3 months follow-up. In addition, we will check in weekly with participants to monitor for any increased distress. We will also measure parental distress to explore whether an intervention for adolescents has an impact on parental wellbeing.
Detailed description
Background and rationale On Friday 15 March 2019, two mosques in Christchurch were targeted in an act of terrorism. A white supremacist shooter attacked approximately 300 people, resulting in 51 deaths and 71 further people injured. The attack has been described as an attack on the Muslim faith and those affected by the event have expressed the importance of spiritual support as well as mental health support in the wake of the tragedy. Research into the effects of the attacks on adults in the Muslim community has identified significant concern over young people's mental health 1. A comprehensive framework of community support for children and adolescents was established involving collaboration between schools, primary care, community NGOs and secondary mental health services however the uptake of these services has been lower than expected despite reports of a growing need for support in these age groups1. Stigma regarding mental illness and distress has been identified as a major barrier to accessing supports.
Psychological distress, anxiety and depression are common in adolescence with substantial personal, societal and economic costs2,3. Transdiagnostic interventions (interventions which can be used across different mental health conditions) have gained support in treatment for adults, and evidence is emerging for their use in adolescent populations4-7. Evidence-informed holistic approaches to supporting wellbeing and mental health place less emphasis on pathology and can be more strengths-based with a focus on values. These approaches may appeal to young people and their families concerned about stigma and labelling 'difficulties' as 'disorders'.
Spiritually integrated psychotherapy has a growing evidence base and is associated with treatment adherence and therapeutic outcome8. An Islamic Psychology approach recognises spirituality as integral to the human experience, with models of Islamic psychotherapy gaining traction in recent years9. A model of traditionally integrated Islamic psychotherapy incorporates five interconnected elements; Áql (cognition), nafs (behavioural inclination), ruh (spirit), ihsas (emotion) and qalb (heart)10.
Holistic approaches to health are not new in New Zealand. Maori models of health are increasingly being adopted such as the Te Whare Tapa Wha model, emphasizing four cornerstones of Maori health11. These include Taha tinana (physical health), Taha wairua (spiritual health), Taha whanau (family health) and Taha hinengaro (mental health).
The proposed study offers a novel treatment approach for teenagers affected by the shootings, incorporating well-evidenced transdiagnostic treatment principles into an Islamic psychology framework to address the local population's need. It will assess the likely size of treatment effect on reported emotional difficulties and post-traumatic stress symptoms, and the feasibility of this approach in supporting wellbeing. We also will measure parental distress (mental health difficulties and physical symptoms) to explore whether an intervention for adolescents has an impact on parental wellbeing. The programme will also provide the opportunity to screen and identify individuals who may benefit from referral to further supports.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Trial Design This is a randomised control trial with a sequential waitlist control design to measure treatment effect sizes on primary and secondary outcomes of participant and parental wellbeing. We also will assess the methods of delivery, face validity and acceptability of treatment. Teenagers (aged 12-19) from the community will be recruited and allocated randomly to either two gender-specific groups to receive the same intervention over 6 weeks or to a comparison group who will be offered the intervention later. This balances the need for control groups while also widening access to the intervention for recruited participants. The study will be community-based in one site (Ōtautahi, Christchurch, New Zealand), with an emphasis on widening access to mental health supports in a minority community by maintaining cultural sensitivity and reducing stigma associated with mental illness.
| Arm | Type | Receives |
|---|---|---|
| transdiagnostic group protocol | Experimental | Behavioral: transdiagnostic group treatmentThe study will run two gender-specific treatment groups (8 participants each) recruited from the community, with one individual session (for information, consent and initial data collection) and 6 group sessions. Both groups will receive the same intervention. A second round of recruitment will run later with anticipated n of 32 in the experimental arm. |
| Waitlist control | Other | Behavioral: transdiagnostic group treatmentAt both recruitment rounds, we will recruit 16 young people to receive the same intervention at a later stage. We will ask them to complete data collection at the same timepoints as the experimental arm participants to compare intervention effect size but will offer them the intervention afterwards so they still have access to the group. Data collected from them in the group will be used to assess feasibility and acceptability but not treatment effect size comparison. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- All high school enrolled teenagers
- English speaking
- Participants do not need to identify as Muslim but will be made aware that the protocol incorporates elements of the Muslim faith.
Key exclusion criteria (4 listed)
- active psychosis,
- severe substance use,
- intellectual disability
- non-English speaking young people.
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 |
|---|---|---|
| transdiagnostic group treatmentThe individual and group sessions will integrate core principles from Motivational interviewing (provide information, address barriers), Cognitive Behavioural Therapy (psychoeducation regarding emotions, enhancing emotional awareness, cognitive restructuring, behavioural experiments, relaxation) , Acceptance Commitment Therapy (mindfulness, grounding, emotional and body awareness, enhancing cognitive flexibility), and aspects of Islamic psychology. | Behavioural | Waitlist control, transdiagnostic group protocol |
Primary outcome
Total problems score
Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
change in total problems score in Strengths and Difficulties Questionnaire (SDQ), self report and parent report.Scored 0-40 with higher scores indicating more problems.
Emotional problems subscore
Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
change in emotional problems subscore in Strengths and Difficulties Questionnaire (SDQ), self report and parent report. Score ranges 0-10 with higher scores indicating more emotional difficulties.
Trauma symptoms
Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
change in total score of Child Revised Impact of Event Score (8 item ) (CRIES-8) by self report, score range 0-40, higher scores indicate more PTSD symptoms.
Somatic Symptom burden
Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
change in somatic symptoms measured using Somatic Symptom Scale (8-item) (SSS-8) self report questionnaire by participants and parents. 5 point Likert scale gives a total score with range 0-32. Cutoff scores identify individuals with low (4-7), medium (8-11), high(12-15), and very high (16-32)somatic symptom burden.
Functional assessment
Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
change in function measured using Children's Global Assessment Scale (CGAS) by clinician. Clinicians give a single global score ranging from 0-100 with higher scores indicating better functioning.
Time to recruitment
Time frame: Measured before first group session at week 3.
Time in weeks required to enrol 16 participants and hold initial individual session.
Implementation
Time frame: Each session will be audio-recorded and scored (at individual session at week 1, weekly group sessions weeks 3- 7, and 3 month follow up/week 19)
measured by use of fidelity scale to rate adherence to planned session content
Psychological flexibility
Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
change in score on Acceptance and Action Questionnaire (AAQ-2), self
Awareness of experience
Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
change in score on Awareness Indicator (AI), new measure asking about awareness of thoughts(aql), body sensations, feelings/emotions, and spiritual heart (qalb and ruh)
7 secondary outcomes
Parental distress
Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Suicidal risk
Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Participant Wellbeing
Time frame: at each individual (week 1) and group session (weeks 3-7) and at 3 month follow up (week 19).
Personality traits
Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Attendance rates
Time frame: recorded at each weekly group session (weeks 3-7) and data collection point (at individual session at week 1, final group session at 7 weeks and 3 month follow up/week 19).
Participant experience/acceptability
Time frame: After each individual (week 1) and weekly group session (weeks 3-7). A brief qualitative interview with each participant at the final group session at week 7 will also ask for their experience of the group.
Retention
Time frame: At final data collection point at week 19.
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 12 May 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. This study is not recruiting at the moment.
Caroline Bell, MD study director
University of Otago, Christchurch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transdiagnostic group treatment in people with Psychological Distress and Trauma, Psychological, run by University of Otago at 1 site in New Zealand.
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 3 inclusion and 4 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 12 May 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 New Zealand. 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?
Total problems score (time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).). The study lists 9 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 12 May 2026.