Psychological OrientationNCT02354183
Commitment and Motivation in a Brief DBT Intervention for Self Harm
A study testing DBT Skills Training in people with Psychological Orientation and Acceptance Processes, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Research suggests that individuals with Borderline Personality Disorder (BPD) experience low motivation for change (Skodal, Buckley, \& Charles, 1983). Dialectical Behavior Therapy (DBT; Linehan, 1993) includes commitment strategies that are designed to improve motivation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psychological Orientation, Acceptance Processes
- What is being tested?
- DBT Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Apr 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a valid health card issued by a Canadian province or Canadian student organization (ie: UHIP)
- Has had at least 3 self-harm episodes (either suicidal or non-suicidal) in the past 5 years, including at least 1 in the past eight weeks
- Is literate in English
- Absence of 4 or more formal weeks of DBT in the past year (individual or group therapy components)
- Indicates absence of knowledge of the DBT Skills
- Is able to attend all sessions on scheduled study day
Who cannot join
- 1) Evidence of organic brain syndrome or mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Research suggests that individuals with Borderline Personality Disorder (BPD) experience low motivation for change (Skodal, Buckley, \& Charles, 1983). Dialectical Behavior Therapy (DBT; Linehan, 1993) includes commitment strategies that are designed to improve motivation. No studies have examined the effectiveness of these strategies. The proposed study will evaluate the efficacy of a brief DBT intervention consisting of commitment strategies plus skills training for people who self-harm. Participants will be randomly assigned to either a single orientation session of (1) commitment strategies plus psychoeducation or (2) psychoeducation. Immediately following their orientation session, all participants will be enrolled in a 90 minute group skills training session. Primary outcomes include autonomous motivation and frequency of self harm behaviours. Assessments will be conducted at six time points: baseline, after the initial orientation session, after the skills training group session, and at one week, one month, and three month follow-up
Read the detailed description
Client motivation is related to therapeutic change (Ryan, Lynch, Vansteenkiste, \& Deci) and low motivation is a pervasive issue for clients with BPD (e.g., Skodal et al., 1983). DBT (Linehan, 1993) is an effective treatment for BPD and was developed in part to address client motivation. Within DBT there are commitment strategies that are used to help clients establish clear goals and increase motivation to work on them. These strategies were designed to help people commit to eliminating self-harm as well as other behaviours. People are more motivated to work effectively towards goals for which they are autonomously motivated (Deci \& Ryan, 2000). Despite their importance in DBT, commitment strategies have never been studied. This study will examine whether commitment strategies are associated with an increase in autonomous motivation and a decrease in self harm behaviour.
This research will address two primary questions: 1) Are commitment strategies associated with an increase in autonomous motivation to decrease self-harm behaviour?; and 2) Does autonomous motivation mediate a relationship between commitment strategies and change in self-harm behaviour? The investigators will also address a secondary question related to predictors of autonomous motivation. Our hypotheses are as follows: 1) The group receiving psychoeducation enhanced with commitment strategies will have higher levels of autonomous motivation compared to the psychoeducation control group; and 2) autonomous motivation will mediate the relationship between commitment strategies and decreases in self harm behaviour. Additionally, autonomy support, low therapist judgment, and goal concordance between client and therapist will independently contribute to predicting client autonomous motivation.
Research in this area is needed in light of the challenges presented by the low motivation that often characterizes individuals with borderline traits who engage in self-harm behaviour. No studies to date have examined DBT's commitment strategies, thus, the effect of these treatment strategies is unknown and needs to be established. Additionally, identifying specific variables that are associated with motivation to eliminate self-harm will help inform the refinement treatment strategies. Finally, few studies have examined the role of autonomous motivation and treatment outcome.
- Conditions
- Psychological Orientation, Acceptance Processes
- Being tested
- DBT Skills Training
- Keywords
- Commitment strategies, Motivation, DBT skills, Self-harm, Brief intervention
- Medical subject headings
- Orientation, Spatial, Behavior, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT Skills TrainingBehavioural
Based on Linehan's (1993) manualized DBT approach, the brief DBT skills training group covers will cover five skills: wise mind, TIP skills, distraction, mindfulness of the current emotion, and opposite to emotion action.
| Study group | Role | What they receive |
|---|---|---|
| Commitment | Experimental | A 1-hour orientation session consisting of DBT commitment strategies plus psychoeducation. Therapists will also use commitment strategies to discuss goals related to self-harm. The psychoeducation will consist of information about DBT's biosocial theory and about why people self-harm. All participants will complete a DBT skills training group after their orientation. Receives: Behavioral: DBT Skills Training |
| Psychoeducation | Active comparator | A 1-hour orientation session consisting of psychoeducation only. The psychoeducation will consist of information about DBT's biosocial theory and about why people self-harm. All participants will complete a DBT skills training group after their orientation. Receives: Behavioral: DBT Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Autonomous and Controlled Motivation
Autonomous and controlled motivation will be assessed using the Autonomous and Controlled Motivation for Treatment Questionnaire (Zuroff et al., 2005).
Measured: From baseline until 3 months following the completion of the 1-day intervention (i.e., average of 3 months)
Secondary outcomes (1)
Change in Frequency and severity of self-harm behaviour
The frequency and severity of self-harm behaviour will be assessed using the Deliberate Self-Harm Inventory, a 17-item self-report questionnaire.
Measured: From baseline until 3 months following the completion of the 1-day intervention (i.e., average of 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological OrientationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Leybman, Centre for Addiction and Mental Health
- Investigators
- Michelle Leybman, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354183
- Sponsor's protocol ID
- 070/2013
- Status last verified
- Feb 2017
- First submitted
- 10 Dec 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Commitment and Motivation in a Brief DBT Intervention for Self Harm
- ClinicalTrials.gov ID
- NCT02354183
- Acronym / sponsor ID
- 070/2013
- Conditions
- Psychological Orientation, Acceptance Processes
- Keywords
- Commitment strategies, Motivation, DBT skills, Self-harm, Brief intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 Feb 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.
Research suggests that individuals with Borderline Personality Disorder (BPD) experience low motivation for change (Skodal, Buckley, \& Charles, 1983). Dialectical Behavior Therapy (DBT; Linehan, 1993) includes commitment strategies that are designed to improve motivation. No studies have examined the effectiveness of these strategies. The proposed study will evaluate the efficacy of a brief DBT intervention consisting of commitment strategies plus skills training for people who self-harm. Participants will be randomly assigned to either a single orientation session of (1) commitment strategies plus psychoeducation or (2) psychoeducation. Immediately following their orientation session, all participants will be enrolled in a 90 minute group skills training session. Primary outcomes include autonomous motivation and frequency of self harm behaviours. Assessments will be conducted at six time points: baseline, after the initial orientation session, after the skills training group session, and at one week, one month, and three month follow-up
Detailed description
Client motivation is related to therapeutic change (Ryan, Lynch, Vansteenkiste, \& Deci) and low motivation is a pervasive issue for clients with BPD (e.g., Skodal et al., 1983). DBT (Linehan, 1993) is an effective treatment for BPD and was developed in part to address client motivation. Within DBT there are commitment strategies that are used to help clients establish clear goals and increase motivation to work on them. These strategies were designed to help people commit to eliminating self-harm as well as other behaviours. People are more motivated to work effectively towards goals for which they are autonomously motivated (Deci \& Ryan, 2000). Despite their importance in DBT, commitment strategies have never been studied. This study will examine whether commitment strategies are associated with an increase in autonomous motivation and a decrease in self harm behaviour.
This research will address two primary questions: 1) Are commitment strategies associated with an increase in autonomous motivation to decrease self-harm behaviour?; and 2) Does autonomous motivation mediate a relationship between commitment strategies and change in self-harm behaviour? The investigators will also address a secondary question related to predictors of autonomous motivation. Our hypotheses are as follows: 1) The group receiving psychoeducation enhanced with commitment strategies will have higher levels of autonomous motivation compared to the psychoeducation control group; and 2) autonomous motivation will mediate the relationship between commitment strategies and decreases in self harm behaviour. Additionally, autonomy support, low therapist judgment, and goal concordance between client and therapist will independently contribute to predicting client autonomous motivation.
Research in this area is needed in light of the challenges presented by the low motivation that often characterizes individuals with borderline traits who engage in self-harm behaviour. No studies to date have examined DBT's commitment strategies, thus, the effect of these treatment strategies is unknown and needs to be established. Additionally, identifying specific variables that are associated with motivation to eliminate self-harm will help inform the refinement treatment strategies. Finally, few studies have examined the role of autonomous motivation and treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commitment | Experimental | Behavioral: DBT Skills TrainingA 1-hour orientation session consisting of DBT commitment strategies plus psychoeducation. Therapists will also use commitment strategies to discuss goals related to self-harm. The psychoeducation will consist of information about DBT's biosocial theory and about why people self-harm. All participants will complete a DBT skills training group after their orientation. |
| Psychoeducation | Active comparator | Behavioral: DBT Skills TrainingA 1-hour orientation session consisting of psychoeducation only. The psychoeducation will consist of information about DBT's biosocial theory and about why people self-harm. All participants will complete a DBT skills training group after their orientation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has a valid health card issued by a Canadian province or Canadian student organization (ie: UHIP)
- Has had at least 3 self-harm episodes (either suicidal or non-suicidal) in the past 5 years, including at least 1 in the past eight weeks
- Is literate in English
- Absence of 4 or more formal weeks of DBT in the past year (individual or group therapy components)
- Indicates absence of knowledge of the DBT Skills
Key exclusion criteria (1 listed)
- 1) Evidence of organic brain syndrome or mental retardation
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 |
|---|---|---|
| DBT Skills TrainingBased on Linehan's (1993) manualized DBT approach, the brief DBT skills training group covers will cover five skills: wise mind, TIP skills, distraction, mindfulness of the current emotion, and opposite to emotion action. | Behavioural | Commitment, Psychoeducation |
Primary outcome
Change in Autonomous and Controlled Motivation
Time frame: From baseline until 3 months following the completion of the 1-day intervention (i.e., average of 3 months)
Autonomous and controlled motivation will be assessed using the Autonomous and Controlled Motivation for Treatment Questionnaire (Zuroff et al., 2005).
1 secondary outcome
Change in Frequency and severity of self-harm behaviour
Time frame: From baseline until 3 months following the completion of the 1-day intervention (i.e., average of 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 10 Feb 2017.
- Derived from this study: PubMed 33884617Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating CentreLink 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.
Michelle Leybman, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT Skills Training in people with Psychological Orientation and Acceptance Processes, run by Centre for Addiction and Mental Health 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 6 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: finished, as of the sponsor's last update on 10 Feb 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 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?
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?
Change in Autonomous and Controlled Motivation (time frame: From baseline until 3 months following the completion of the 1-day intervention (i.e., average of 3 months)). 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 NCT02354183, which also lists 1 linked publication.
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 10 Feb 2017.