Post Traumatic Stress DisorderNCT04592770
Effect of Exercise on Post-traumatic Growth Among Health Care Providers With Post-traumatic Stress
A study testing Nature based walk therapy and Sit in nature in people with Post Traumatic Stress Disorder, run by University of Karachi at 1 site in Pakistan.
Trial summary
The purpose of designing this randomized control trial is to observe the effect of nature-based walk on post-traumatic growth and Psychophysiological alterations associated with it, in traumatic stress among health care providers of Karachi Pakistan. Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Nature based walk therapy and Sit in nature
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 10 Aug 2021
- 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 16 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Both genders, aged 16-50 years
- Must be disease free (by their reports), there must be no evidence of any metastatic disease.
- Fluent in written and spoken the Urdu language (National Language of Pakistan).
- Experienced any traumatic event in the last 12 months.
- Informed written consent
- Being able to walk five times per week. (Participants will be asked to complete the Physical Activity Readiness Questionnaire)
Who cannot join
- Subjects who received a structured psychological intervention for at least six months during the last three years performed by a psychologist or psychiatrist will be excluded.
- Those with a codified psychiatric disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) who received Psychopharmacological treatment during the last three years will also be excluded from the study sample.
- Those subjects who had developed Post Traumatic Growth. (will be evaluated from Post Traumatic Growth Inventory)
- Those subjects who do not have any trauma intensity. (will be evaluated from Trauma Symptom Checklist 40)
- Subjects who are at high risk for physical injury during exercise.
- Self-reported current and regular exercise in nature
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nature-based Exercise on Post-traumatic Growth Among People With Post-traumatic Stress: A Randomized Placebo-controlled Trial Designed to Observe Psychophysiological Alterations Before to After Intervention
The purpose of designing this randomized control trial is to observe the effect of nature-based walk on post-traumatic growth and Psychophysiological alterations associated with it, in traumatic stress among health care providers of Karachi Pakistan. This study is planned to investigate the recreational exposure to the natural environment for the promotion of PTG, in the traumatic stress subjects and to determine whether PTG is associated with psychophysiological alterations, i.e. C-Reactive Protein, Brain Derived Neurotropic Factor, Interleukin-6, Cortisol, and Heart Rate Variability. Subjects who had experienced any traumatic event in the last 12 months will be recruited, and at baseline, the participant will be assessed with Trauma Symptom Checklist 40 to evaluate trauma intensity. Moreover, subjects who had developed PTG or did not have any trauma intensity will be excluded from the study. Blinded treatment will be provided to subjects meeting eligibility criteria and will be randomized into two groups sequentially as they agree to participate. The nature-based walk will be used as intervention vs the control (relax in nature). The study outcomes will be monitored in subjects of both groups at different intervals, i.e. at baseline and 3-month follow-up (post-interventional).
Read the detailed description
Plan of work
- Enrollment: Those subjects who had experienced any traumatic event in the last 12 months will be enrolled.
- Assessment of eligibility: Subject meeting eligibility criteria will be included in the study.
- Baseline assessment: All the variables, i.e. Post-traumatic growth inventory (PTGI), Trauma symptom checklist-40 (TSC-40), Traumatic stress scale (TSS), C-Reactive protein (CRP), Brain-derived neurotrophic factor (BDNF), Interleukin-6 (IL-6), Cortisol and Heart rate variability (HRV) will be measured at baseline.
- Randomization: Subjects based on eligibility criteria will be randomly allocated to the experimental or control group sequentially as they agree to participate.
- Allocation: A booklet with detailed instructions will be provided to the study subjects according to the groups allocated.
- Follow-up assessment: After 3 months, all the variables measured at the baseline phase will be measured again.
- Statistical Analysis: Pre \& post-analysis will be conducted in this phase.
Participants Subjects for the present study will be recruited from 5 Health care organizations based in Karachi, Pakistan. The targeted population includes subjects from diverse ethnicity and considered eligible for participation in the study if they indicated in a pre-screening form that they had experienced a traumatic event. These subjects will be invited to participate in the study through advertisements on the notice board of each center. Written informed consent will be obtained from each study subject after providing detailed information regarding the objectives of the study and its duration.
Randomization Subjects based on eligibility criteria will be randomly allocated to the experimental or control group in the 1:1 ratio. Computer-generated random numbers will be used for randomization. After taking the subject's basic information, a unique code will be provided to each included subject by the study center. The code will be mentioned in each form of each subject.
Interventions • The experimental intervention: In this group, the nature walk will take place in a conserved and by far the largest recreational area of Karachi city. The safari park covering an area of 148 acres (0.60 km2), It has a zoo, geared with woodland, mountain viewing, safari tracks, as well as two natural lakes. The experiment will take place in the afternoon on a 5 km marked area. The duration of the stretching exercise sessions will be of 10 minutes followed by 50 minutes' walk session five times per week (total 12 weeks). participants will be asked to walk at moderate pace.
- The control intervention: Subjects will undergo 12 weeks of nature therapy that includes exposure to natural landscapes. The duration of the sessions will be 60 minutes five times per week. The subjects will be asked to sit and relax in the evening, in the same recreational area which is used for the experimental group.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Nature based walk therapy, Sit in nature
- Keywords
- natural environment, walking, post traumatic growth, traumatic stress
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature based walk therapyBehavioural
Also called Experimental
10 minutes stretching exercises followed by walk in nature for 50 minutes
Sit in natureBehavioural
Also called Control
Sit in nature for 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| The experimental intervention (walk): | Experimental | In this group, the nature walk will take place in a conserved and by far the largest recreational area of Karachi city. The safari park covering an area of 148 acres (0.60 km2), It has a zoo, geared with woodland, mountain viewing, safari tracks, as well as two natural lakes. The experiment will take place in the afternoon on a 5 km marked area. The duration of the stretching exercise sessions will be of 10 minutes followed by 50 minutes' walk session five times per week (total 12 weeks). participants will be asked to walk at moderate pace. Receives: Behavioral: Nature based walk therapy |
| The control intervention (sit & relax): | Placebo comparator | Subjects will undergo 12 weeks of nature therapy that includes exposure to natural landscapes. The duration of the sessions will be 60 minutes five times per week. The subjects will be asked to sit and relax in the evening, in the same recreational area which is used for the experimental group. Receives: Behavioral: Sit in nature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Traumatic Growth (PTG)
Change in post-traumatic growth from baseline to post-intervention assessment. Post-Traumatic Growth Inventory will be used to assess this outcome. This inventory is comprising of 21 questions based on 5 factors i.e. spiritual modifications, self-conception and alterations in viewpoints, relationship changes, new motivations and interests in life and the discovery of individual resources attainable by themselves and others. Likert scale will be used for rating where 0 means no change experienced, to increasing consequently as 5 means change experienced to a greater degree.
Measured: 3 Months
Traumatic Stress
Change in traumatic Stress from baseline to post-intervention assessment. trauma symptom checklist - 40 will be used to assess this outcome. This 40-item instrument measure assesses trauma-related problems in categories like Dissociation, Anxiety, Depression, SATI (Sexual Abuse Trauma Index), Sleep Disturbance \& Sexual Problems. using a four point scale ranging from 0 means never, to 3 means often.
Measured: 3 Months
Secondary outcomes (4)
C- Reactive Protein (CRP)
Change in the CRP level will be observed among the subjects enrolled in the experimental group as compared to the control group
Measured: 3 Months
Brain-derived neurotrophic factor (BDNF)
Change in the BDNF level will be observed among the subjects enrolled in the experimental group as compared to the control group
Measured: 3 Months
Interleukin-6 (IL-6)
Change in the IL-6 level will be observed among the subjects enrolled in the experimental group as compared to the control group
Measured: 3 Months
Cortisol
Change in the cortisol level will be observed among the subjects enrolled in the experimental group as compared to the control group
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jan 2021
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shamoon Noushad, University of Karachi
- Investigators
- Basit Ansari, Ph.D, Study chair, University of KarachiSadaf Ahmed, Ph.D, Study director, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592770
- Sponsor's protocol ID
- KU-DoHPESS-5
- Status last verified
- Feb 2023
- First submitted
- 1 Oct 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alper B, Erdogan B, Erdogan MO, Bozan K, Can M. Associations of Trauma Severity with Mean Platelet Volume and Levels of Systemic Inflammatory Markers (IL1beta, IL6, TNFalpha, and CRP). Mediators Inflamm. 2016;2016:9894716. doi: 10.1155/2016/9894716. Epub 2016 Apr 5.
PubMed 27127347Brown DK, Barton JL, Gladwell VF. Viewing nature scenes positively affects recovery of autonomic function following acute-mental stress. Environ Sci Technol. 2013 Jun 4;47(11):5562-9. doi: 10.1021/es305019p. Epub 2013 May 16.
PubMed 23590163Gladwell VF, Brown DK, Barton JL, Tarvainen MP, Kuoppa P, Pretty J, Suddaby JM, Sandercock GR. The effects of views of nature on autonomic control. Eur J Appl Physiol. 2012 Sep;112(9):3379-86. doi: 10.1007/s00421-012-2318-8. Epub 2012 Jan 21.
PubMed 22270487Gladwell VF, Brown DK, Wood C, Sandercock GR, Barton JL. The great outdoors: how a green exercise environment can benefit all. Extrem Physiol Med. 2013 Jan 3;2(1):3. doi: 10.1186/2046-7648-2-3.
PubMed 23849478Hartig T, Mitchell R, de Vries S, Frumkin H. Nature and health. Annu Rev Public Health. 2014;35:207-28. doi: 10.1146/annurev-publhealth-032013-182443. Epub 2014 Jan 2.
PubMed 24387090Kerai SM, Khan UR, Islam M, Asad N, Razzak J, Pasha O. Post-traumatic stress disorder and its predictors in emergency medical service personnel: a cross-sectional study from Karachi, Pakistan. BMC Emerg Med. 2017 Aug 29;17(1):26. doi: 10.1186/s12873-017-0140-7.
PubMed 28851280Kondo MC, Fluehr JM, McKeon T, Branas CC. Urban Green Space and Its Impact on Human Health. Int J Environ Res Public Health. 2018 Mar 3;15(3):445. doi: 10.3390/ijerph15030445.
PubMed 29510520Britton E, Kindermann G, Domegan C, Carlin C. Blue care: a systematic review of blue space interventions for health and wellbeing. Health Promot Int. 2020 Feb 1;35(1):50-69. doi: 10.1093/heapro/day103.
PubMed 30561661Li Q, Otsuka T, Kobayashi M, Wakayama Y, Inagaki H, Katsumata M, Hirata Y, Li Y, Hirata K, Shimizu T, Suzuki H, Kawada T, Kagawa T. Acute effects of walking in forest environments on cardiovascular and metabolic parameters. Eur J Appl Physiol. 2011 Nov;111(11):2845-53. doi: 10.1007/s00421-011-1918-z. Epub 2011 Mar 23.
PubMed 21431424Michopoulos V, Norrholm SD, Jovanovic T. Diagnostic Biomarkers for Posttraumatic Stress Disorder: Promising Horizons from Translational Neuroscience Research. Biol Psychiatry. 2015 Sep 1;78(5):344-53. doi: 10.1016/j.biopsych.2015.01.005. Epub 2015 Jan 30.
PubMed 25727177Ohly H, White MP, Wheeler BW, Bethel A, Ukoumunne OC, Nikolaou V, Garside R. Attention Restoration Theory: A systematic review of the attention restoration potential of exposure to natural environments. J Toxicol Environ Health B Crit Rev. 2016;19(7):305-343. doi: 10.1080/10937404.2016.1196155. Epub 2016 Sep 26.
PubMed 27668460Valtchanov D, Barton KR, Ellard C. Restorative effects of virtual nature settings. Cyberpsychol Behav Soc Netw. 2010 Oct;13(5):503-12. doi: 10.1089/cyber.2009.0308. Epub 2010 Feb 25.
PubMed 20950174Noushad S, Ahmed S, Ansari B, Mustafa UH, Saleem Y, Hazrat H. Physiological biomarkers of chronic stress: A systematic review. Int J Health Sci (Qassim). 2021 Sep-Oct;15(5):46-59.
PubMed 34548863
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nature-based Exercise on Post-traumatic Growth Among People With Post-traumatic Stress: A Randomized Placebo-controlled Trial Designed to Observe Psychophysiological Alterations Before to After Intervention
- ClinicalTrials.gov ID
- NCT04592770
- Acronym / sponsor ID
- KU-DoHPESS-5
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- natural environment, walking, post traumatic growth, traumatic stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of designing this randomized control trial is to observe the effect of nature-based walk on post-traumatic growth and Psychophysiological alterations associated with it, in traumatic stress among health care providers of Karachi Pakistan. This study is planned to investigate the recreational exposure to the natural environment for the promotion of PTG, in the traumatic stress subjects and to determine whether PTG is associated with psychophysiological alterations, i.e. C-Reactive Protein, Brain Derived Neurotropic Factor, Interleukin-6, Cortisol, and Heart Rate Variability. Subjects who had experienced any traumatic event in the last 12 months will be recruited, and at baseline, the participant will be assessed with Trauma Symptom Checklist 40 to evaluate trauma intensity. Moreover, subjects who had developed PTG or did not have any trauma intensity will be excluded from the study. Blinded treatment will be provided to subjects meeting eligibility criteria and will be randomized into two groups sequentially as they agree to participate. The nature-based walk will be used as intervention vs the control (relax in nature). The study outcomes will be monitored in subjects of both groups at different intervals, i.e. at baseline and 3-month follow-up (post-interventional).
Detailed description
Plan of work
- Enrollment: Those subjects who had experienced any traumatic event in the last 12 months will be enrolled.
- Assessment of eligibility: Subject meeting eligibility criteria will be included in the study.
- Baseline assessment: All the variables, i.e. Post-traumatic growth inventory (PTGI), Trauma symptom checklist-40 (TSC-40), Traumatic stress scale (TSS), C-Reactive protein (CRP), Brain-derived neurotrophic factor (BDNF), Interleukin-6 (IL-6), Cortisol and Heart rate variability (HRV) will be measured at baseline.
- Randomization: Subjects based on eligibility criteria will be randomly allocated to the experimental or control group sequentially as they agree to participate.
- Allocation: A booklet with detailed instructions will be provided to the study subjects according to the groups allocated.
- Follow-up assessment: After 3 months, all the variables measured at the baseline phase will be measured again.
- Statistical Analysis: Pre \& post-analysis will be conducted in this phase.
Participants Subjects for the present study will be recruited from 5 Health care organizations based in Karachi, Pakistan. The targeted population includes subjects from diverse ethnicity and considered eligible for participation in the study if they indicated in a pre-screening form that they had experienced a traumatic event. These subjects will be invited to participate in the study through advertisements on the notice board of each center. Written informed consent will be obtained from each study subject after providing detailed information regarding the objectives of the study and its duration.
Randomization Subjects based on eligibility criteria will be randomly allocated to the experimental or control group in the 1:1 ratio. Computer-generated random numbers will be used for randomization. After taking the subject's basic information, a unique code will be provided to each included subject by the study center. The code will be mentioned in each form of each subject.
Interventions • The experimental intervention: In this group, the nature walk will take place in a conserved and by far the largest recreational area of Karachi city. The safari park covering an area of 148 acres (0.60 km2), It has a zoo, geared with woodland, mountain viewing, safari tracks, as well as two natural lakes. The experiment will take place in the afternoon on a 5 km marked area. The duration of the stretching exercise sessions will be of 10 minutes followed by 50 minutes' walk session five times per week (total 12 weeks). participants will be asked to walk at moderate pace.
- The control intervention: Subjects will undergo 12 weeks of nature therapy that includes exposure to natural landscapes. The duration of the sessions will be 60 minutes five times per week. The subjects will be asked to sit and relax in the evening, in the same recreational area which is used for the experimental group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental intervention (walk): | Experimental | Behavioral: Nature based walk therapyIn this group, the nature walk will take place in a conserved and by far the largest recreational area of Karachi city. The safari park covering an area of 148 acres (0.60 km2), It has a zoo, geared with woodland, mountain viewing, safari tracks, as well as two natural lakes. The experiment will take place in the afternoon on a 5 km marked area. The duration of the stretching exercise sessions will be of 10 minutes followed by 50 minutes' walk session five times per week (total 12 weeks). participants will be asked to walk at moderate pace. |
| The control intervention (sit & relax): | Placebo comparator | Behavioral: Sit in natureSubjects will undergo 12 weeks of nature therapy that includes exposure to natural landscapes. The duration of the sessions will be 60 minutes five times per week. The subjects will be asked to sit and relax in the evening, in the same recreational area which is used for the experimental group. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Both genders, aged 16-50 years
- Must be disease free (by their reports), there must be no evidence of any metastatic disease.
- Fluent in written and spoken the Urdu language (National Language of Pakistan).
- Experienced any traumatic event in the last 12 months.
- Informed written consent
Key exclusion criteria (6 listed)
- Subjects who received a structured psychological intervention for at least six months during the last three years performed by a psychologist or psychiatrist will be excluded.
- Those with a codified psychiatric disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) who received Psychopharmacological treatment during the last three years will also be excluded from the study sample.
- Those subjects who had developed Post Traumatic Growth. (will be evaluated from Post Traumatic Growth Inventory)
- Those subjects who do not have any trauma intensity. (will be evaluated from Trauma Symptom Checklist 40)
- Subjects who are at high risk for physical injury during exercise.
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 |
|---|---|---|
| Nature based walk therapyAlso: Experimental10 minutes stretching exercises followed by walk in nature for 50 minutes | Behavioural | The experimental intervention (walk): |
| Sit in natureAlso: ControlSit in nature for 60 minutes | Behavioural | The control intervention (sit & relax): |
Primary outcome
Post-Traumatic Growth (PTG)
Time frame: 3 Months
Change in post-traumatic growth from baseline to post-intervention assessment. Post-Traumatic Growth Inventory will be used to assess this outcome. This inventory is comprising of 21 questions based on 5 factors i.e. spiritual modifications, self-conception and alterations in viewpoints, relationship changes, new motivations and interests in life and the discovery of individual resources attainable by themselves and others. Likert scale will be used for rating where 0 means no change experienced, to increasing consequently as 5 means change experienced to a greater degree.
Traumatic Stress
Time frame: 3 Months
Change in traumatic Stress from baseline to post-intervention assessment. trauma symptom checklist - 40 will be used to assess this outcome. This 40-item instrument measure assesses trauma-related problems in categories like Dissociation, Anxiety, Depression, SATI (Sexual Abuse Trauma Index), Sleep Disturbance \& Sexual Problems. using a four point scale ranging from 0 means never, to 3 means often.
4 secondary outcomes
C- Reactive Protein (CRP)
Time frame: 3 Months
Brain-derived neurotrophic factor (BDNF)
Time frame: 3 Months
Interleukin-6 (IL-6)
Time frame: 3 Months
Cortisol
Time frame: 3 Months
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 8 Feb 2023.
- Background: PubMed 27127347Alper B, Erdogan B, Erdogan MO, Bozan K, Can M. Associations of Trauma Severity with Mean Platelet Volume and Levels of Systemic Inflammatory Markers (IL1beta, IL6, TNFalpha, and CRP). Mediators Inflamm. 2016;2016:9894716. doi: 10.1155/2016/9894716. Epub 2016 Apr 5.
- Background: PubMed 23590163Brown DK, Barton JL, Gladwell VF. Viewing nature scenes positively affects recovery of autonomic function following acute-mental stress. Environ Sci Technol. 2013 Jun 4;47(11):5562-9. doi: 10.1021/es305019p. Epub 2013 May 16.
- Background: PubMed 22270487Gladwell VF, Brown DK, Barton JL, Tarvainen MP, Kuoppa P, Pretty J, Suddaby JM, Sandercock GR. The effects of views of nature on autonomic control. Eur J Appl Physiol. 2012 Sep;112(9):3379-86. doi: 10.1007/s00421-012-2318-8. Epub 2012 Jan 21.
- Background: PubMed 23849478Gladwell VF, Brown DK, Wood C, Sandercock GR, Barton JL. The great outdoors: how a green exercise environment can benefit all. Extrem Physiol Med. 2013 Jan 3;2(1):3. doi: 10.1186/2046-7648-2-3.
- Background: PubMed 24387090Hartig T, Mitchell R, de Vries S, Frumkin H. Nature and health. Annu Rev Public Health. 2014;35:207-28. doi: 10.1146/annurev-publhealth-032013-182443. Epub 2014 Jan 2.
- Background: PubMed 28851280Kerai SM, Khan UR, Islam M, Asad N, Razzak J, Pasha O. Post-traumatic stress disorder and its predictors in emergency medical service personnel: a cross-sectional study from Karachi, Pakistan. BMC Emerg Med. 2017 Aug 29;17(1):26. doi: 10.1186/s12873-017-0140-7.
- Background: PubMed 29510520Kondo MC, Fluehr JM, McKeon T, Branas CC. Urban Green Space and Its Impact on Human Health. Int J Environ Res Public Health. 2018 Mar 3;15(3):445. doi: 10.3390/ijerph15030445.
- Background: PubMed 30561661Britton E, Kindermann G, Domegan C, Carlin C. Blue care: a systematic review of blue space interventions for health and wellbeing. Health Promot Int. 2020 Feb 1;35(1):50-69. doi: 10.1093/heapro/day103.
- Background: PubMed 21431424Li Q, Otsuka T, Kobayashi M, Wakayama Y, Inagaki H, Katsumata M, Hirata Y, Li Y, Hirata K, Shimizu T, Suzuki H, Kawada T, Kagawa T. Acute effects of walking in forest environments on cardiovascular and metabolic parameters. Eur J Appl Physiol. 2011 Nov;111(11):2845-53. doi: 10.1007/s00421-011-1918-z. Epub 2011 Mar 23.
- Background: PubMed 25727177Michopoulos V, Norrholm SD, Jovanovic T. Diagnostic Biomarkers for Posttraumatic Stress Disorder: Promising Horizons from Translational Neuroscience Research. Biol Psychiatry. 2015 Sep 1;78(5):344-53. doi: 10.1016/j.biopsych.2015.01.005. Epub 2015 Jan 30.
- Background: PubMed 27668460Ohly H, White MP, Wheeler BW, Bethel A, Ukoumunne OC, Nikolaou V, Garside R. Attention Restoration Theory: A systematic review of the attention restoration potential of exposure to natural environments. J Toxicol Environ Health B Crit Rev. 2016;19(7):305-343. doi: 10.1080/10937404.2016.1196155. Epub 2016 Sep 26.
- Background: PubMed 20950174Valtchanov D, Barton KR, Ellard C. Restorative effects of virtual nature settings. Cyberpsychol Behav Soc Netw. 2010 Oct;13(5):503-12. doi: 10.1089/cyber.2009.0308. Epub 2010 Feb 25.
- Study ResultsLink provided by the sponsor.
- 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.
Basit Ansari, Ph.D study chair
University of Karachi
Sadaf Ahmed, Ph.D study director
University of Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature based walk therapy and Sit in nature in people with Post Traumatic Stress Disorder, run by University of Karachi at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 8 Feb 2023. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
Post-Traumatic Growth (PTG) (time frame: 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04592770, which also lists 13 linked publications.
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 8 Feb 2023.