Post-traumatic Stress DisorderArt_Tx_PTSDNCT02610049
Trial of Art Therapy During Cognitive Processing Therapy for PTSD
A study testing Cognitive Processing therapy, Art + CPT and CPT + Art Therapy in people with Post-traumatic Stress Disorder and Stress Disorder, Post-Traumatic, run by Hampton VA Medical Center at 1 site in United States.
Trial summary
This is a randomized, controlled trial of adjunctive art therapy during cognitive processing therapy for PTSD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder, Stress Disorder, Post-Traumatic
- What is being tested?
- Cognitive Processing therapy, Art + CPT and CPT + Art Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 13 Feb 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PCL-M initial score >= 50;
- Both genders,
- All ethnicities,
- Veterans in treatment for PTSD,
Who cannot join
- No active substance use disorder,
- No active suicidal or homicidal ideation,
- No psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled Trial of Art Therapy During Cognitive Processing Therapy for PTSD
This is a randomized, controlled trial of adjunctive art therapy during cognitive processing therapy for PTSD.
Read the detailed description
The objective of this study is to examine the effects of art therapy with combat veterans who have PTSD and to measure if it reduces symptoms more than verbal Cognitive Processing Therapy (CPT) alone. This study will incorporate art processes and materials into an already established protocol of CPT in order to create a sense of safety for veterans in beginning therapy, and access the nonverbal parts of the trauma in order to process it. Art-making will be used to help veterans address trauma and integrate who they were before the trauma with who they are currently. It will assist in addressing the grief and loss caused by combat, and will be used as veterans begin building a worldview and self-concept that are not filled with trauma and war. It is hypothesized that the veterans who receive art therapy with CPT will show a significantly greater decrease in PTSD symptoms than those who receive only CPT.
- Being tested
- Cognitive Processing therapy, Art + CPT, CPT + Art Therapy
- Keywords
- PTSD
- 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.
Cognitive Processing therapyBehavioural
Also called CPT
8 sessions of standard CPT from CPT manual developed by Dr. S Resick, Monson \& Chard (11/2010)
Art + CPTBehavioural
8 sessions of individual therapy of mixes techniques Art + CPT 8 sessions of standard CPT (same 8 as in control group) from manual developed by Dr.s Resick, Monson \& Chard (11/2010)
CPT + Art TherapyBehavioural
Subjects to complete 8 sessions of standard Cognitive Processing Therapy from manual developed by Dr. S. Resick, Monson \& Chard (1/2010) CPT + Art Therapy of mixed individual techniques
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Subjects will receive 8 sessions of Cognitive Processing Therapy. Receives: Behavioral: Cognitive Processing therapy |
| Experimental | Experimental | Subjects will receive 8 sessions of CPT + Art Therapy 8 sessions of individual therapy. Receives: Behavioral: Art + CPT |
| Experimental 2 | Experimental | Subject to receive 8 sessions of individual therapy for Art + CPT Cognitive Processing Therapy intervention pre-specified to be administered separately. Receives: Behavioral: CPT + Art Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptoms assessed by PCL-M score
PTSD symptoms will be measured by PCL-M score
Measured: 8-12 weeks
Depression Symptoms assessed by Beck Depression Inventory-II
Beck Depression Inventory-II will be used to measure depression
Measured: 8-12 weeks
Secondary outcomes (2)
Treatment Satisfaction assessed by Likert scale
Likert scale will be used to compare satisfaction with art and CPT conditions
Measured: 8-12 weeks
Treatment completion assessed by dropout rate
Compare dropout rate between experimental and control groups during treatment
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2013
- Primary completion3 Feb 2017
- Study completion13 Feb 2017
Why it stopped: Investigator has retired.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hampton VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Barbara Cross, Ph.D., FNP, Study chair, IRB Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610049
- Sponsor's protocol ID
- 13-04
- Acronym
- Art_Tx_PTSD
- Status last verified
- Aug 2017
- First submitted
- 17 Nov 2015
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made available to other researchers. Aggregated data and de-identified data could be potentially be shared at a future date.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial of Art Therapy During Cognitive Processing Therapy for PTSD
- ClinicalTrials.gov ID
- NCT02610049
- Acronym / sponsor ID
- Art_Tx_PTSD / 13-04
- Keywords
- PTSD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator has retired.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hampton VA Medical CenterUS federal agency
- Study start
- Nov 2013 (actual)
- Primary completion
- 3 Feb 2017 (actual)
- Study completion
- 13 Feb 2017 (actual)
- First posted
- 20 Nov 2015 (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.
This is a randomized, controlled trial of adjunctive art therapy during cognitive processing therapy for PTSD.
Detailed description
The objective of this study is to examine the effects of art therapy with combat veterans who have PTSD and to measure if it reduces symptoms more than verbal Cognitive Processing Therapy (CPT) alone. This study will incorporate art processes and materials into an already established protocol of CPT in order to create a sense of safety for veterans in beginning therapy, and access the nonverbal parts of the trauma in order to process it. Art-making will be used to help veterans address trauma and integrate who they were before the trauma with who they are currently. It will assist in addressing the grief and loss caused by combat, and will be used as veterans begin building a worldview and self-concept that are not filled with trauma and war. It is hypothesized that the veterans who receive art therapy with CPT will show a significantly greater decrease in PTSD symptoms than those who receive only CPT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Cognitive Processing therapySubjects will receive 8 sessions of Cognitive Processing Therapy. |
| Experimental | Experimental | Behavioral: Art + CPTSubjects will receive 8 sessions of CPT + Art Therapy 8 sessions of individual therapy. |
| Experimental 2 | Experimental | Behavioral: CPT + Art TherapySubject to receive 8 sessions of individual therapy for Art + CPT Cognitive Processing Therapy intervention pre-specified to be administered separately. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PCL-M initial score >= 50;
- Both genders,
- All ethnicities,
- Veterans in treatment for PTSD,
Key exclusion criteria (3 listed)
- No active substance use disorder,
- No active suicidal or homicidal ideation,
- No psychosis
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 |
|---|---|---|
| Cognitive Processing therapyAlso: CPT8 sessions of standard CPT from CPT manual developed by Dr. S Resick, Monson \& Chard (11/2010) | Behavioural | Control |
| Art + CPT8 sessions of individual therapy of mixes techniques Art + CPT 8 sessions of standard CPT (same 8 as in control group) from manual developed by Dr.s Resick, Monson \& Chard (11/2010) | Behavioural | Experimental |
| CPT + Art TherapySubjects to complete 8 sessions of standard Cognitive Processing Therapy from manual developed by Dr. S. Resick, Monson \& Chard (1/2010) CPT + Art Therapy of mixed individual techniques | Behavioural | Experimental 2 |
Primary outcome
PTSD Symptoms assessed by PCL-M score
Time frame: 8-12 weeks
PTSD symptoms will be measured by PCL-M score
Depression Symptoms assessed by Beck Depression Inventory-II
Time frame: 8-12 weeks
Beck Depression Inventory-II will be used to measure depression
2 secondary outcomes
Treatment Satisfaction assessed by Likert scale
Time frame: 8-12 weeks
Treatment completion assessed by dropout rate
Time frame: 8-12 weeks
Results and safety
The study was stopped early (reason given: Investigator has retired.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made available to other researchers. Aggregated data and de-identified data could be potentially be shared at a future date.
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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.
Barbara Cross, Ph.D., FNP study chair
IRB Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing therapy, Art + CPT and CPT + Art Therapy in people with Post-traumatic Stress Disorder and Stress Disorder, Post-Traumatic, run by Hampton VA Medical Center at 1 site in United States.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 9 Aug 2017. 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 United States. 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 was stopped early (reason given: Investigator has retired.). Results are not available in the source record.
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?
PTSD Symptoms assessed by PCL-M score (time frame: 8-12 weeks). 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?
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 9 Aug 2017.