AnxietyNCT02290678
Pushing Limits - Adventure: Pilot Study
A study testing Adventure-based Programming in people with Anxiety and Depression, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Team building exercises have been shown to be effective in improving an individual's ability to work within a group and build working relationships with others. Adventure Therapy assimilates team building exercises and teachings into an adventure style excursion into the wilderness or other non-typical environment. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Adventure-based Programming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of a mood disorder and a clinician referral.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St Joseph's Healthcare Hamilton
Hamilton, Ontario, L9C0E3
Laura Garrick, CCRA, 9055221155 ext. 35409, lgarrick@stjoes.ca
About this study
Official title: Examining the Feasibility and Efficacy of Adventure Based Therapy as a Treatment Intevention for Depression and Anxiety.
Team building exercises have been shown to be effective in improving an individual's ability to work within a group and build working relationships with others. Adventure Therapy assimilates team building exercises and teachings into an adventure style excursion into the wilderness or other non-typical environment. This combination of exposure and learning creates a unique experience for participants which preliminary research suggests is effective in reducing feelings of hopelessness, guilt, and shame and may increase empathy, self-concept, self-confidence, and subjects' well-being have also been shown to be improved by adventure therapy.
This study will use a series of questionnaires and interviews to determine whether an adventure based therapy is both effective and reasonable as a treatment for people with mood disorders like depression and anxiety. The objective of this study is to investigate the efficacy of adventure based therapy as a treatment intervention for outpatients with mood disorders. The investigators will observe any changes in mood, perceived self- efficacy, anxiety, self-stigma, hope, quality of life enjoyment and satisfaction, leisure motivation, and stress as a result of this intervention. As well, the investigators aim to capture participant's opinions of the program.
Read the detailed description
"Adventure programming is the use of experiential and challenging approaches to education, recreation, life skills and counseling. It is the use of new, unique and relevant activities to supplement conventional learning processes. Adventure-based activities are tailored to achieve desired outcomes related to specified learning objectives. The core purpose is to intensify learning and insight by focusing on the process that occurs during challenging activities."
Adventure Based Therapy (AT) is a unique approach to traditional therapy strategies. AT is based on the philosophy of "experiential education", which is defined as "learning by doing, with reflection". The idea of experiential learning is based on the belief that learning is a result of direct experience, and learning is most effective when multiple senses are actively involved. By increasing the intensity of the mental and physical demands of learning, one can be fully engaged in the learning by simultaneously stimulating all sensory systems. Psychological research on information processing indicates that multi-sensory processing increases cognitive activity such as problem solving, processing of an experience, and memory. AT combines physical activity, social empowerment, and problem solving skills into a multi-sensory experience.
Recent literature suggests that AT can benefit patients' recovery. For example, preliminary work suggests that AT is effective in reducing feelings of hopelessness, guilt, and shame, and may increase empathy. Self-concept, self-confidence, and subjects' well-being have also been shown to be improved by AT. The concept of AT stems from the idea of team building exercises, and the notion that through participation patients experience increased group cohesion, therapeutic alliance, and communication and negotiation skills. Here, we will assess these variables in patients with mood disorders participating in AT using an extensive assessment battery. In addition, we will follow patients longitudinally to assess the durability of these effects.
The present research will be a pilot study designed to modify the protocol for the main trial. We will assess engagement in treatment by exploring participants' actual experiences and how they attribute meaning to their involvement in the therapeutic adventure based program. A qualitative research design that uses the Grounded Theory method will be used. Grounded Theory promotes a focus on individuals in real life situations and local social contexts. Qualitative interviews give participants the opportunity to have their voices or stories included in research studies as well as contribute to the development of effective treatment interventions. Feasibility of the trial will be determined by analyzing resource and economic utilization throughout the pilot.
- Conditions
- Anxiety, Depression
- Being tested
- Adventure-based Programming
- Keywords
- Pilot Study, Adventure-based Programming
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adventure-based ProgrammingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participate in a two day Adventure-based Programming retreat and team building exercises. Receives: Behavioral: Adventure-based Programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, as measured by Number of Participants who complete the Adventure-based Programming retreat and team building exercises and Qualitative engagement feedback
Interviews will be conducted with participants to determine the success in engagement of participants and the execution of the study (including allocation of staff, resources, etc.).
Measured: Up to 2 weeks following intervention
Secondary outcomes (6)
BDI-II Score
Difference in the score of the Beck Depression Inventory II immediately after the intervention compared to baseline immediately before intervention.
Measured: Up to 1 week following intervention
BDI-II Score
How well the difference in the score of the Beck Depression Inventory II is retained at 1 month compared to immediately after the intervention.
Measured: 1 month following intervention
BDI-II Score
How well the difference in the score of the Beck Depression Inventory II is retained at 3 months compared to immediately after the intervention.
Measured: 3 months following intervention
BAI Score
Difference in the score of the Beck Anxiety Inventory immediately after the intervention compared to baseline immediately before intervention.
Measured: Up to 1 week following intervention
BAI Score
How well the difference in the score of the Beck Anxiety Inventory is retained at 1 month compared to immediately after the intervention.
Measured: 1 month following intervention
BAI Score
How well the difference in the score of the Beck Anxiety Inventory is retained at 3 month compared to immediately after the intervention.
Measured: 3 months following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret McKinnon, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290678
- Sponsor's protocol ID
- Adventure_PILOT
- Status last verified
- Feb 2015
- First submitted
- 4 Nov 2014
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Anderson, L., Schleien, S. J., McAvoy, L., Lais, G., & Seligmann, D. (1997). Creating positive change through an integrated outdoor adventure program. Therapeutic Recreation Journal, Fourth Quarter, 214-229.
Bandoroff, S. & Newes, S. "Coming Of Age: Evolving Field of Adventure Therapy" (2004). Association for Experiential Education. Volume 3.
Beck, A. T., & Steer, R. A. (1990). Manual for the Beck Anxiety Inventory. San Antonio, TX: Psychological Corporation.
BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369Gillen, M., & Balkin, R. (2006). Adventure counseling as an adjunct to group counseling in hospital and clinical settings. Journal for Specialists in Group Work, 31(2), 153-164. doi: 10.1080/01933920500493746
Ewert, A. W., McCormick, B. P., & Voight, A. E. (2001). Outdoor experiential therapies: Implications for TR practice. Therapeutic Recreation Journal, Second Quarter, 170-122.
Chakravorty, D., Trunnell, E. P., & Ellis, G. D. (1995). Ropes course participation and post-activity processing on transient depressed mood of hospitalized adult psychiatric patients. Therapeutic Recreation Journal, Second Quarter, 104-113.
Charmaz, K. (2003). Grounded Theory: Objectivist and Constructivist Methods. Strategies of Qualitative Inquiry, Denzin & Lincoln (EDS.). Sage.
Charmaz, K. (2006). Constructing grounded theory: A practical guide through qualitative analysis, Pine Forge Press.
Corbin, J. & Strauss, A. (2008). Basics of qualitative research: Techniques and procedures for developing grounded theory, Sage.
Kyriakopoulos, A. (2011). How individuals with self-reported anxiety and depression experienced a combination of individual counseling along with an adventurous outdoor experience: A qualitative evaluation. Counseling and Psychotherapy Research, 11(2), 120-128. doi: 10.1080/14733145.2010.485696
Liamputtong P. Qualitative data analysis: conceptual and practical considerations. Health Promot J Austr. 2009 Aug;20(2):133-9. doi: 10.1071/he09133.
PubMed 19642962Patton, M.Q. (2002). Qualitative Research & Evaluation Methods. (3rd edition). Thousand Oaks, CA. Sage.
Riley, K. (2011). Effects of a collaborative outpatient therapy program on self-concept of adolescents with depression. Therapeutic Recreation Journal, 45(1), 32-46.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Feasibility and Efficacy of Adventure Based Therapy as a Treatment Intevention for Depression and Anxiety.
- ClinicalTrials.gov ID
- NCT02290678
- Acronym / sponsor ID
- Adventure_PILOT
- Conditions
- Anxiety, Depression
- Keywords
- Pilot Study, Adventure-based Programming
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 Nov 2014 (estimated)
- 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.
Team building exercises have been shown to be effective in improving an individual's ability to work within a group and build working relationships with others. Adventure Therapy assimilates team building exercises and teachings into an adventure style excursion into the wilderness or other non-typical environment. This combination of exposure and learning creates a unique experience for participants which preliminary research suggests is effective in reducing feelings of hopelessness, guilt, and shame and may increase empathy, self-concept, self-confidence, and subjects' well-being have also been shown to be improved by adventure therapy.
This study will use a series of questionnaires and interviews to determine whether an adventure based therapy is both effective and reasonable as a treatment for people with mood disorders like depression and anxiety. The objective of this study is to investigate the efficacy of adventure based therapy as a treatment intervention for outpatients with mood disorders. The investigators will observe any changes in mood, perceived self- efficacy, anxiety, self-stigma, hope, quality of life enjoyment and satisfaction, leisure motivation, and stress as a result of this intervention. As well, the investigators aim to capture participant's opinions of the program.
Detailed description
"Adventure programming is the use of experiential and challenging approaches to education, recreation, life skills and counseling. It is the use of new, unique and relevant activities to supplement conventional learning processes. Adventure-based activities are tailored to achieve desired outcomes related to specified learning objectives. The core purpose is to intensify learning and insight by focusing on the process that occurs during challenging activities."
Adventure Based Therapy (AT) is a unique approach to traditional therapy strategies. AT is based on the philosophy of "experiential education", which is defined as "learning by doing, with reflection". The idea of experiential learning is based on the belief that learning is a result of direct experience, and learning is most effective when multiple senses are actively involved. By increasing the intensity of the mental and physical demands of learning, one can be fully engaged in the learning by simultaneously stimulating all sensory systems. Psychological research on information processing indicates that multi-sensory processing increases cognitive activity such as problem solving, processing of an experience, and memory. AT combines physical activity, social empowerment, and problem solving skills into a multi-sensory experience.
Recent literature suggests that AT can benefit patients' recovery. For example, preliminary work suggests that AT is effective in reducing feelings of hopelessness, guilt, and shame, and may increase empathy. Self-concept, self-confidence, and subjects' well-being have also been shown to be improved by AT. The concept of AT stems from the idea of team building exercises, and the notion that through participation patients experience increased group cohesion, therapeutic alliance, and communication and negotiation skills. Here, we will assess these variables in patients with mood disorders participating in AT using an extensive assessment battery. In addition, we will follow patients longitudinally to assess the durability of these effects.
The present research will be a pilot study designed to modify the protocol for the main trial. We will assess engagement in treatment by exploring participants' actual experiences and how they attribute meaning to their involvement in the therapeutic adventure based program. A qualitative research design that uses the Grounded Theory method will be used. Grounded Theory promotes a focus on individuals in real life situations and local social contexts. Qualitative interviews give participants the opportunity to have their voices or stories included in research studies as well as contribute to the development of effective treatment interventions. Feasibility of the trial will be determined by analyzing resource and economic utilization throughout the pilot.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Adventure-based ProgrammingParticipate in a two day Adventure-based Programming retreat and team building exercises. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of a mood disorder and a clinician referral.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Adventure-based Programming | Behavioural | Intervention |
Primary outcome
Feasibility, as measured by Number of Participants who complete the Adventure-based Programming retreat and team building exercises and Qualitative engagement feedback
Time frame: Up to 2 weeks following intervention
Interviews will be conducted with participants to determine the success in engagement of participants and the execution of the study (including allocation of staff, resources, etc.).
6 secondary outcomes
BDI-II Score
Time frame: Up to 1 week following intervention
BDI-II Score
Time frame: 1 month following intervention
BDI-II Score
Time frame: 3 months following intervention
BAI Score
Time frame: Up to 1 week following intervention
BAI Score
Time frame: 1 month following intervention
BAI Score
Time frame: 3 months following intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
- BackgroundAnderson, L., Schleien, S. J., McAvoy, L., Lais, G., & Seligmann, D. (1997). Creating positive change through an integrated outdoor adventure program. Therapeutic Recreation Journal, Fourth Quarter, 214-229.
- BackgroundBandoroff, S. & Newes, S. "Coming Of Age: Evolving Field of Adventure Therapy" (2004). Association for Experiential Education. Volume 3.
- BackgroundBeck, A. T., & Steer, R. A. (1990). Manual for the Beck Anxiety Inventory. San Antonio, TX: Psychological Corporation.
- Background: PubMed 13688369BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- BackgroundGillen, M., & Balkin, R. (2006). Adventure counseling as an adjunct to group counseling in hospital and clinical settings. Journal for Specialists in Group Work, 31(2), 153-164. doi: 10.1080/01933920500493746
- BackgroundEwert, A. W., McCormick, B. P., & Voight, A. E. (2001). Outdoor experiential therapies: Implications for TR practice. Therapeutic Recreation Journal, Second Quarter, 170-122.
- BackgroundChakravorty, D., Trunnell, E. P., & Ellis, G. D. (1995). Ropes course participation and post-activity processing on transient depressed mood of hospitalized adult psychiatric patients. Therapeutic Recreation Journal, Second Quarter, 104-113.
- BackgroundCharmaz, K. (2003). Grounded Theory: Objectivist and Constructivist Methods. Strategies of Qualitative Inquiry, Denzin & Lincoln (EDS.). Sage.
- BackgroundCharmaz, K. (2006). Constructing grounded theory: A practical guide through qualitative analysis, Pine Forge Press.
- BackgroundCorbin, J. & Strauss, A. (2008). Basics of qualitative research: Techniques and procedures for developing grounded theory, Sage.
- BackgroundKyriakopoulos, A. (2011). How individuals with self-reported anxiety and depression experienced a combination of individual counseling along with an adventurous outdoor experience: A qualitative evaluation. Counseling and Psychotherapy Research, 11(2), 120-128. doi: 10.1080/14733145.2010.485696
- Background: PubMed 19642962Liamputtong P. Qualitative data analysis: conceptual and practical considerations. Health Promot J Austr. 2009 Aug;20(2):133-9. doi: 10.1071/he09133.
- Directly quoted from in the project description. Gives a brief overview of Adventure Programming.Link provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adventure-based Programming in people with Anxiety and Depression, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Feb 2015. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Garrick, CCRA (9055221155 ext. 35409, lgarrick@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, as measured by Number of Participants who complete the Adventure-based Programming retreat and team building exercises and Qualitative engagement feedback (time frame: Up to 2 weeks following intervention). 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 NCT02290678, which also lists 14 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 20 Feb 2015.