Complicated GriefPhase 1NCT01556048
Pilot Study of Behavioral Activation for Prolonged Grief
A Phase 1 study testing Behavioral Activation in people with Complicated Grief and Prolonged Grief Disorder, run by Anthony Papa at 1 site in United States.
Trial summary
The Institute of Medicine identifies Prolonged Grief (PG) as a critical under-addressed public health problem for which are no empirically supported treatments. The purpose of this application is to pilot-test Behavioral Activation (BA) therapy for PG. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Complicated Grief, Prolonged Grief Disorder, Major Depressive Disorder
- What is being tested?
- Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to May 2012
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet criteria for Prolonged Grief Disorder
- must be 21 years old or older
- if taking psychotropic medication, must have been on a stable dose for three or more months prior to study entry
Who cannot join
- presence of active suicidal or homicidal ideation
- a history of psychotic symptoms
- current participation in psychosocial treatment focused on grief symptoms
- active substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
The Institute of Medicine identifies Prolonged Grief (PG) as a critical under-addressed public health problem for which are no empirically supported treatments. The purpose of this application is to pilot-test Behavioral Activation (BA) therapy for PG. BA is a well supported, stand alone intervention for depression and recently applied to posttraumatic stress disorder, which reduces rumination and avoidance behaviors that otherwise thwart access to natural rewarding contingencies and resources. The treatment focuses on promoting stable, active routines, self-care behaviors, enhanced self-efficacy, and reengagement with pleasurable activities and significant social resources. Rumination, disengagement, and low self-efficacy are defining features of PG. Further, in response to loss of intimates, the key factors that differentiate resilient people from those that have difficulties adapting is the maintenance or fast resumption of social and occupational functioning. Thus, the main hypothesis of this study is that BA for PG will result in clinically significant reductions in rumination and functional disengagement. This is a preliminary small-scale pilot assessment of potential efficacy and feasibility of completing a large scale study of BA for PG.
- Conditions
- Complicated Grief, Prolonged Grief Disorder, Major Depressive Disorder, Posttraumatic Stress Disorder
- Being tested
- Behavioral Activation
- Keywords
- Behavior therapy, Bereavement, Complicated grief, Depression, Posttraumatic Stress Disorder
- Medical subject headings
- Prolonged Grief Disorder, Depressive Disorder, Major, Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
Behavioral Activation for Major Depressive Disorder (BA; Martell, Addis, \& Jacobson, 2001) is based on behavioral theories of depression, which posit that psychopathology occurs when active, goal-directed behavioral repertoires have been either unreinforced or punished. These aversive consequences tend to reinforce escape and avoidance behavior, such as passively ruminating on unmet needs and/or deprivations, rather than actively engaging the environment. BA employs operant conditioning principles to increase active, goal-directed behavioral strategies and decrease passive or avoidant behavioral strategies to help people engage with and obtain adequate reinforcement from their environment. Use of BA was based research suggesting that disengagement/avoidance is related to prolonged pathology after loss
| Study group | Role | What they receive |
|---|---|---|
| IMMEDIATE START GROUP | Experimental | Randomized to participate in Behavioral Activation for pathological grief starting at Week 1 of entry into the study Receives: Behavioral: Behavioral Activation |
| DELAY START GROUP | Placebo comparator | Randomized to participate in Behavioral Activation for pathological grief starting at Week 12 of entry into the study Receives: Behavioral: Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in grief symptoms at weeks 12, 24, and 36 post randomization
Inventory of Complicated Grief-Revised
Measured: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
Change from Baseline in PTSD symptoms at weeks 12, 24, and 36 post randomization
PTSD Checklist-Specific
Measured: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
Change from Baseline in symptoms of Major Depressive Disorder at Weeks 12, 24, and 36 post randomization
Depression Anxiety Stress Scales
Measured: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
Secondary outcomes (2)
Change from Baseline in levels of rumination at Weeks 12, 24, and 36 post randomization
Ruminative Response Scale
Measured: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
Therapy credibility and client expectancy for improvement after treatment
Credibility/ Expectancy Questionnaire
Measured: Assessments occurring post-treatment (12 weeks for immediate start group, 24 weeks for delay start group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startFeb 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated GriefStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthony Papa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anthony Papa, University of Nevada, Las Vegas
- Investigators
- Antony Papa, Ph.D., Principal investigator, University of Nevada, Reno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556048
- Sponsor's protocol ID
- SA08/09-07
- Status last verified
- Dec 2014
- First submitted
- 12 Mar 2012
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Behavioral Activation for Prolonged Grief
- ClinicalTrials.gov ID
- NCT01556048
- Acronym / sponsor ID
- SA08/09-07
- Conditions
- Complicated Grief, Prolonged Grief Disorder, Major Depressive Disorder, Posttraumatic Stress Disorder
- Keywords
- Behavior therapy, Bereavement, Complicated grief, Depression, Posttraumatic Stress Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Anthony PapaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 16 Mar 2012 (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.
The Institute of Medicine identifies Prolonged Grief (PG) as a critical under-addressed public health problem for which are no empirically supported treatments. The purpose of this application is to pilot-test Behavioral Activation (BA) therapy for PG. BA is a well supported, stand alone intervention for depression and recently applied to posttraumatic stress disorder, which reduces rumination and avoidance behaviors that otherwise thwart access to natural rewarding contingencies and resources. The treatment focuses on promoting stable, active routines, self-care behaviors, enhanced self-efficacy, and reengagement with pleasurable activities and significant social resources. Rumination, disengagement, and low self-efficacy are defining features of PG. Further, in response to loss of intimates, the key factors that differentiate resilient people from those that have difficulties adapting is the maintenance or fast resumption of social and occupational functioning. Thus, the main hypothesis of this study is that BA for PG will result in clinically significant reductions in rumination and functional disengagement. This is a preliminary small-scale pilot assessment of potential efficacy and feasibility of completing a large scale study of BA for PG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMMEDIATE START GROUP | Experimental | Behavioral: Behavioral ActivationRandomized to participate in Behavioral Activation for pathological grief starting at Week 1 of entry into the study |
| DELAY START GROUP | Placebo comparator | Behavioral: Behavioral ActivationRandomized to participate in Behavioral Activation for pathological grief starting at Week 12 of entry into the study |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- meet criteria for Prolonged Grief Disorder
- must be 21 years old or older
- if taking psychotropic medication, must have been on a stable dose for three or more months prior to study entry
Key exclusion criteria (4 listed)
- presence of active suicidal or homicidal ideation
- a history of psychotic symptoms
- current participation in psychosocial treatment focused on grief symptoms
- active substance abuse
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 |
|---|---|---|
| Behavioral ActivationBehavioral Activation for Major Depressive Disorder (BA; Martell, Addis, \& Jacobson, 2001) is based on behavioral theories of depression, which posit that psychopathology occurs when active, goal-directed behavioral repertoires have been either unreinforced or punished. These aversive consequences tend to reinforce escape and avoidance behavior, such as passively ruminating on unmet needs and/or deprivations, rather than actively engaging the environment. BA employs operant conditioning principles to increase active, goal-directed behavioral strategies and decrease passive or avoidant behavioral strategies to help people engage with and obtain adequate reinforcement from their environment. Use of BA was based research suggesting that disengagement/avoidance is related to prolonged pathology after loss | Behavioural | DELAY START GROUP, IMMEDIATE START GROUP |
Primary outcome
Change from Baseline in grief symptoms at weeks 12, 24, and 36 post randomization
Time frame: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
Inventory of Complicated Grief-Revised
Change from Baseline in PTSD symptoms at weeks 12, 24, and 36 post randomization
Time frame: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
PTSD Checklist-Specific
Change from Baseline in symptoms of Major Depressive Disorder at Weeks 12, 24, and 36 post randomization
Time frame: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
Depression Anxiety Stress Scales
2 secondary outcomes
Change from Baseline in levels of rumination at Weeks 12, 24, and 36 post randomization
Time frame: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
Therapy credibility and client expectancy for improvement after treatment
Time frame: Assessments occurring post-treatment (12 weeks for immediate start group, 24 weeks for delay start group)
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 2 Dec 2014.
Related trials for Complicated Grief
Recruiting
Transcranial Magnetic Stimulation to Treat Prolonged Grief Disorder
Prolonged Grief Disorder, Complicated Grief
Not yet recruiting
Sleep Difficulties After Loss: Exploring the Beneficial Effect of Brief Behavioral Therapy for Insomnia in a Sample of Bereaved Individuals
Insomnia, Insomnia Chronic
Active, not recruitingObservational study
The Aarhus Bereavement Study
Grief
Active, not recruiting
Alba - a Mobile App to Provide Bereavement Support for Adolescents in Grief
Complicated Grief Disorder
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.
Antony Papa, Ph.D. principal investigator
University of Nevada, Reno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Behavioral Activation in people with Complicated Grief and Prolonged Grief Disorder, run by Anthony Papa 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 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 2 Dec 2014. 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. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 from Baseline in grief symptoms at weeks 12, 24, and 36 post randomization (time frame: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization). The study lists 3 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 2 Dec 2014.