Evidence-Based Synthesis Program - 16 -Department of Veteran Affairs

Family Involved Psychosocial Treatments for Adult Mental Health Conditions

**Transcript of Cyberseminar**

**Department of Veterans Affairs**

**Evidence Based Synthesis Program (ESP)**

**Family Involved Psychosocial Treatments for Adult Mental Health Conditions**

**Laura Meis, PhD**

**Shirley Glynn, PhD**

**June 18, 2012**

Moderator:  Hi, everyone.  This is Heidi Schlueter of CIDER, and I want to welcome you to today’s ESP session.  Today’s session is Family-Involved Psychosocial Treatments for Adult Mental Health Condition.  

Laura Meis:  I’m Laura Meis, and I’ll be presenting on our review today, the review that we conducted here at the Minneapolis VA.  I am a core investigator at our Center of Excellence for health services, research, and development; a clinical psychologist and study couples and post-traumatic stress disorder.  We also have Shirley here as a panelist, who will help me, and we’ll talk together after to answer questions after I present on this systematic review.  Did you want to say a few things about your background, Shirley?

Shirley Glynn:  Sure.  For those of you who don’t know me, my name’s Shirley Glynn.  I’m a clinical research psychologist at the West L.A. VA, and I work half time with the office of mental health services just trying to support the dissemination of family services, in particular EBPs throughout the VA.  

Laura Meis:  I will take the first forty-five or fifty minutes to present on our review, and then we’ll field questions after that.  Before we started of course I want to acknowledge our team, this is definitely a team effort,  I want to thank all my co authors as well as our expert panel members and our reviewers and Tim O’Farrell for his assistancs with the substance use study. This very busy slide basically says that we have no conflicts of interest and that the opinions are our own and not the United States Governments or the Dept of Veterans Affairs. And then I have a few slides just overviewing the Evidence-based Synthesis Program so as I mentioned, this is a review that was sponsored by the VA’s program that does evidence-based syntheses, and the ESP program establishes reviews on important and interesting topics to the VA.  Anybody can nominate a review; here’s the Web site at the bottom of this slide where you can nominate a review if you want to.  The ESP program is overseen by a steering committee, and each review, including our own, has a technical advisory panel which provides constant expertise and guides us throughout.  Each project, including our own, is peer reviewed.  The final report for this review is available on the Internet at the HSR&D Web site at the bottom of this slide.

Now, we can get into the weeds on this project.  I have a couple of poll questions in here; here is the first one.  I just wanted to get a sense of the audience, how many people we’re talking to that are trainees versus clinicians or researchers.  If everybody could take a minute and just respond to this question, I will continue to talk about our program and come back to these.

Looks like we have a lot of clinicians and a small comparison of researchers and others.  I will try to speak to those audiences as well as possible.

Here is the basic map for what we’re going to be talking about today.  It’s structured like the technical review.  I’m going to start with an overview of why we did this project, how we identified our key questions and our strategy to approaching the data and searching for articles, and then I’ll talk about our results both broadly and by mental health condition, and then summarize and talk about future research.  The impetus for this review was changing culture in the VA toward the greater emphasis on including families, and actually explicit expansion of VA authority to provide family services.  These changes have prompted a need for the VA to identify efficacious and promising family interventions and also which family interventions are superior to alternative approaches, be they individually oriented treatments or family-oriented treatments.  There’s a real need here to understand the literature of both and physical health conditions for psychosocial interventions that involve family that can improve physical conditions as well as mental health.  The focus today is on mental health, but we are also currently conducting a review of family interventions for physical health conditions.  Here’s the second poll question; as I moved forward in kind of structuring our review and highlighting how that was going to be structured, I wanted to get a sense of peoples’ exposure to this literature.  This just kind of highlights what your knowledge and exposure may be.  Also, I’m curious to what degree that there are people already providing family treatments.  

It looks like about forty percent are moderately familiar with family treatments for mental health conditions, so that’s good.  We also have a good-sized group that is new to this, which is also great.  It’s helpful to have both ends of the spectrum.  

We did a systematic review of randomized clinical trials for mental health conditions that were addressed through a family intervention, so we focused on gold standard approaches to evaluating interventions.  They’re all randomized clinical trials.  Throughout I’m going to be talking about how one intervention was superior to another or similar, and what I mean by that when I say superior is statistically significantly different.  On the given outcome I’m looking at, one intervention was significantly better than the other at the given outcome.  The same is true when I talk about there being no differences, that what I mean is that there were no significant differences between the two.  Obviously they may have different averages on different outcomes.

We defined family how the study did.  Most interventions were family or couples, and they defined what they meant by that.  There were also some that included roommates or other non-traditional family members; these were not the norm, but we did include them when they were defined that way.  That is broader than the VA’s current definition of family for the purposes of providing services within the VA, so that’s something important to think about.  Also, when we were deciding where to start with this review, there have been a number of reviews, usually disorder specific, of family interventions; so a review of behavioral couples therapy for substance use.  However, we wanted to be more comprehensive, but we didn’t want to reinvent the wheel.  

There was one study that was done in ’98 that was a review of family interventions for mental health conditions; they also covered family distress.  Given that that last comprehensive review was in ’98, we decided to focus on the most recent literature.  We focused on the last fifteen years, so we only reviewed randomized clinical trials from ’96 to November of 2012.  Also, to focus on those trials that were most relevant to U.S. veterans, we focused on U.S. studies.  Given all of those parameters, these were our key questions.  Our first question that we wanted to address was an issue of efficacy. To what extent do family-involved interventions for mental health conditions improve outcomes for adult patients?  This first key question is all about how a family intervention compares to no psychosocial treatment, so no other intervention.  The comparator could’ve been a wait list or medication management only, but it was not a psychosocial intervention.  

The second question was about specificity.  To what extent is a family intervention for a mental health condition better than an alternative intervention?  This could be another family treatment, another individual treatment.  It could be more intensive, less intensive, but just some alternative to what extent a given family intervention was more effective than this alternative.  Here is how we approached our data generally.  Our population is adults with mental health conditions and their family members, and we looked at two levels of outcomes.  The first were final outcomes, and another important thing to note here is that these are all patient outcomes.  Given the VA’s need to figure out the best way to improve outcomes for patients, we focused on patient symptom improvement, patient quality of life utilization, and patient reports on family functioning in relationship and couple functioning versus caregivers.  It does not mean that caregiver-focused interventions and caregivers’ perspectives on these variables are unimportant.  It’s just that it was outside the scope of our current review.

We also looked at these intermediate outcomes: attendance, social support, and patient satisfaction under the assumption that these kinds of variables may influence outcomes.  The time frames we looked at were post-treatment; short-term follow-up, which was six months after treatment; and long-term follow-up, which was greater than six months after treatment.  Then as I mentioned, we have the intervention of interest, which has to involve family in some way; it was a psychosocial intervention, not just medication.  The comparators were for our first key question, no psychotherapy; and our second key question, some alternative treatment.  It could have been less intensive, more intensive, and in whatever form.  Also, it’s always important to keep an eye out for adverse effects, so I will highlight those as we found [to be].  

For our search strategy we looked at MEDLINE and PsycINFO; our search terms included whatever iteration of family we could find using standard MeSH terms and whatever iterations of couples and family therapy that also were recommended by standard MeSH terms.  Here’s our inclusion/exclusion criteria, which I’ve basically already kind of gone over, which is that it had to be a randomized clinical trial or a review of a randomized clinical trial between ’96 and 2011, had to be in English, had to have a psychosocial family-involved treatment, address on mental health condition.  It had to have an outcome of interest, as I mentioned, those patient-focused outcomes.  It had to be conducted in the U.S.; we also excluded cities that obviously didn’t address one of our conditions of interest.  

Our approach to our analyses, we coded each of the randomized clinical trials.  I’m going to talk about them narratively; that’s what most of our findings were because there’s so much heterogeneity in the interventions and the comparators that it was very hard to pool things, but we did rate them on a number of criteria.  We rated each randomized clinical trial on using these efficacy guidelines, which are established by prior work.  It could have one of essentially four rankings.  We could rank it as efficacious and specific, which would mean that it was a family intervention, was superior to at least two randomized control trials done by a separate team and compared to an alternative intervention.  This could be a placebo or a non-specific treatment or an alternative equally intensive intervention that would be efficacious and specific.

Secondly, there’s efficacious, which is that the family intervention is superior, again, in two RTCs by two independent teams.  But in this case it’s just compared to no psychosocial treatment.  Then finally we use the word [mod] to modify [our] possibly efficacious or possibly efficacious and specific for interventions that meet the above criteria in just one study.  We also ranked them on the quality of the study, which is just basically the methodological rigor from fair, good, to poor, and strength of the evidence from low, moderate, to high.  By strength of evidence we mean the confidence that the evidence reflects the true effect of that intervention and that additional research is unlikely to change the estimate of that effect.  Those were ranked low, moderate, to high; all of these were using standard procedures for systematic reviews.  When possible, we did pool analyses.  We did conduct meta-analyses.  Unfortunately, again, due to heterogeneity of interventions, comparisons, and outcomes, this was only possible for behavioral couples and behavioral family therapy for substance use.  In that case, we looked at weighted mean differences, Hedges’ g, and the effect sizes ranged from .2 to .5 to .8, eight being a large effect and .2 being a small effect.  

This is the flow of our literature search results.  Our initial search results had nearly 2,500 abstracts that we reviewed at the abstract level and then pulled those that we were uncertain about and reviewed those at full text.  We added a few more studies that were found through hand search and author correspondence and ultimately wound up with a review that included fifty-one articles, and across those fifty-one articles were thirty-nine unique randomized control trials.  Broadly, across the trials that we located, here is a breakdown of what conditions they were addressing.  As you can see, the largest share was for substance use disorders.  There were twenty-two unique randomized clinical trials that included a family intervention for substance use disorders, and bipolar and schizophrenia were the other large groups, then a few others from other conditions.

A couple other important things to note; obviously the veteran trials—there were three done on substance use disorders that were veteran studies, one for post-traumatic stress disorder and the others didn’t report it.  That’s an important thing to highlight in terms from the VA’s perspective about how these studies may apply to veterans.  Lastly you’ll notice there are no cognitive disorders in this list.  We did locate a number of studies that addressed Alzheimer’s disorder and dementia.  Because of the volume of these, we did elect to review them in the physical health condition, which is currently being conducted, the physical health condition review that we’re currently conducting.

Also, looking at these randomized clinical trials globally, each of the thirty-nine trials examined twenty-one different active family treatments.  There are a lot of interventions out there that are being studied in some way that involve family or couples in the treatment.  Most of them were fair quality, and a lot of them excluded individuals who were actively psychotic, suicidal, reported intimate partner violence.  In the cases when a medication was required, such as for psychotic conditions, bipolar disorder, erectile functioning, and some substance use trials, participants were excluded when they were pregnant or they had a medical condition which wouldn’t allow them to use that medication.  Then from the substance use studies, in most cases they excluded cases in which both the patient and the family member both had a substance use condition.

Across the trials, we had eight that compared family interventions to wait-list or medication-only treatment, and thirty-three that compared a family intervention to an alternative intervention.  Next, onto the main results; first is our global response to the answer for key question one, which was the degree to which family interventions are better than a wait-list or a medication-only treatment.  As I mentioned, there were eight studies, and they spanned across six different mental health conditions.  There was a lot of heterogeneity in what we found for this study, and basically what we thought was going on is that there have been a lot of family interventions that have been developed prior to the time frame of our review.  The studies that were included in this key question were those that were newer, that had not been compared to wait-list, and there just weren’t as many of them.  Of the ones that did exist, there were a lot of mixed findings that were either non-significant or favoring the family intervention.  I’m going to go over these briefly, but as these are single trials it’s hard to draw some firm conclusions about them.

The first study that we’re looking at here, Improved Symptoms in Depression, the depression trial that examined brief, disorder specific cognitive behavior couple therapy.  They found that compared to wait-list, this couple therapy improved symptoms in marital adjustment.  This is a small trial.  Secondly, there were two trials that demonstrated a family intervention improved initiation or attendance in the treatment.  One was for PTSD, and it was a support group, the Coffee and Family Education and Support groups, with a family-involved support group.  In this case, it was with Bosnian refugees.  But it was conducted in the U.S.  The other one was a substance use study, so they involved family and after-care planning for patients in detox, and found that by involving family they improved initiation for substance use treatment.

Then there were a number of trials that found no differences in symptoms.  Also, importantly, this detox study also found no differences in symptoms between those who participated in detox only and those who participated in the family-involved after-care planning.  For the PTSD study they did not provide outcomes on symptoms.  There were these four conditions that were covered; in each case, there were no differences in the symptoms, but there were some differences in other important variables.  For bipolar disorder one trial found better global functioning and medication adherence, and for distressed families they found lower mood episodes.  For that sub-group the family intervention was more effective in reducing mood episodes than the medication-only comparisons.

Two trials for erectile dysfunction, which were both brief treatments; one found greater satisfaction with treatment but otherwise non-significant differences.  In two other trials—now, both of these were three-arm trials that had a family condition, an individual condition, and a wait-list condition.  In both cases, the family intervention looked better in terms of symptom response than the wait-list but was not superior to the individually oriented treatment.  In the case of PTSD, the combined treatment, which was exposure plus behavioral family therapy, actually had higher rates of drop-out.  That’s it for our first key question about general efficacy.

Now, on to our second key question, which is about the specificity of these interventions.  I’m going to tackle the largest set of trials here first.  First is the substance use disorder trials; there were twenty-one trials that addressed substance use disorders.  The lion’s share of them were evaluating family or behavioral couples therapy for substance use.  When I use BFT and BCT throughout these slides, I am referring to a disorder-specific treatment.  Behavioral couples therapy is a dyadic; one partner, one family member—or in this case on behavioral couple therapy it’s an intimate partner—and if they are post.  The couple treatment addresses substance use through cognitive behavioral strategies in using the partner to help assist with those strategies and through traditional behavioral couples treatment that addresses communication issues, problem solving, and relationship satisfaction, as well as enabling issues.  Behavioral family therapy is highly similar, but includes an individual that is not necessarily an intimate partner.  For these studies there were a number of BCT/BFT interventions that compared that family intervention to an individual therapy, so we were able to pool analyses for these on substance use outcomes and relationship adjustment.  

There were nine studies that all used percent days absent for their outcome for substance use and ten that used dyadic adjustment scales.  I’ll get into that a little bit more later.  There were also three trials that looked at community reinforcement and family training; this is a family only—so the patient is not involved—group.  Sometimes they’re a group; sometimes they’re with individuals for the family members of those with a substance use problem.  The intention of this intervention is to provide support for the family members and also training and coping skills and the communication skills to assist the family member in getting the patient with a substance use problem into treatment, the treatment initiation intervention.

Then there were two trials in which a unique intervention was examined in a single trial, and I’ll review those briefly as well.  For the BCT and BFT studies, first I’m going to cover the pooled analyses comparing BCT/BFT to individual therapy.  Overall across these trials, what we see when we compare this couples with family intervention to individual therapy is a slower rate of relapse for those in the family intervention.  Essentially the intervention effects erode more slowly over time for those who are in the family treatment.  It takes longer to relapse.  For our meta-analyses we pooled the data, and at each of our time points of interest there were significant differences between those who were in a family treatment versus those who were in the individual treatment on percent days of abstinence from substance use, so at post-treatment, at six months after follow-up, and at twelve months after follow-up.  Those who were in the family condition had significantly greater days of abstinence than those in the individual therapy condition.

Now, I wanted to present this data another way.  The numbers that came up are the differences across the nine trials we pooled on days abstinent between those in the family treatment and those in the individual treatment.  For example, this 1.3; this reflects that the difference between family therapy and individual treatments, that those in family therapy have 1.3 days more abstinence per month than those in individual treatment.  Similarly per year, those in the family treatment had sixteen greater days of abstinence than those in the individual treatment, and the same is true here at six months and here at twelve months.  It turns out that seven of these nine trials were all conducted by the same lab, so we thought it would be important to look at the other labs.  We pooled the data for the two other labs that were not part of this lab that is producing most of the data that came from this.

Here are their numbers; what you can see is they’re actually quite similar, especially looking at six months and twelve months.  The difference in days abstinent was 3.4 for all of the trials; it was 4.1 for the two trials that were done outside of the common lab.  However, there are larger differences here in these post-treatment numbers.  For all trials that included the seven studies that were conducted from the same labs, when you look at the difference between conditions, it’s sixteen days of abstinence over the year at post-treatment.  However, when you look at the two maps that are outside of this large group, the number of days abstinent is 46.4 per year.  It seems as though by looking at this data is that the trials that are coming out of that one large lab appear to be actually potentially underestimating the difference between family treatment and individual treatment.  Onto relationship adjustments, we also pooled the analyses for these.  We pooled this across ten studies.  All of these studies were behavioral couples therapies, so not family.  They were all done by that single lab because they all used the same outcome, the dyadic adjustment scale.  Here I’m going to present the average; here is the average DAS score at post, six months, and twelve months; the average DAS score for those in individual therapies for their average dyadic adjustment scale, and then the effect sizes and confidence intervals.

Looking at the effect sizes, we’re looking at moderate to large effects; they seem to be declining.  The size of the effects does decline from the six to twelve month window, and the post and six month differences in dyadic adjustment between individual treatment and these family interventions is approaching large.  The threshold for large effect size is typically .8 on these.  Also, I think it’s interesting to highlight just the average mean differences across these studies.  Here I’m highlighting the average DAS scores for BCT versus individual therapy.  Now, if you’ll look down here, this 97.5 is often used as a cut-off for clinical distress in relationships.  For those who have participated in behavioral couples therapy, their average DAS score remained within the satisfied range throughout our time points of interest.  These couples were reporting relationship satisfaction within normal limits at each time point.  

However, for individual therapy, after six and nine months the average DAS score dips down below this clinically significant distress level.  At six months and twelve months, the average person who completed individual therapy in these trials was reporting clinically significant relationship distress, whereas those in BCT were not.

The other thing I wanted to highlight here from our technical report is a few of the iterations of behavior couples therapy.  This delves into much greater depth in the technical manual, so if you have more questions I can field them at the end.  If you are curious and want to know more detail, it’s all in the technical report.  The ones I want to focus on, I think, have important clinical relevance.  The first alteration, if you want to call it that, for behavioral couple therapy I wanted to highlight, is behavioral family therapy.  There were two trials that we located in the U.S. that have been done since ’96 that looked at behavioral family therapy, so including a family member other than an intimate partner.  One trial found no differences in substance use, and the other did favor behavioral family therapy at eighteen months.  But these differences, I wrote it up thirty months by the final assessment period, so there are some mixed findings here.

Secondly, behavioral couples therapy versus brief behavioral couples therapy; there was a briefer version of BCT that they compared in these two trials.  Generally the outcomes were largely similar between the longer and shorter version of behavioral couples therapy.  Third is there were two trials that compared traditional behavioral couples therapy for substance use to behavioral couples therapy plus additional relapse prevention sessions.  One trial found no differences, and the other trial was a veterans study.  So I want to spend a moment talking about this for that reason.  In this veterans study, they did find that BCT plus relapse prevention was superior to BCT alone on substance use at eighteen months after treatment.  However, these differences did erode by the final assessment period.  The other interesting statistic that they presented in this paper, which is not a group comparison but looks at each treatment [inaudible].  For those who participated in just behavioral couples therapy, the differences between their relationship adjustment before treatment and after treatment were significantly different through twelve months.  Basically they improved in their relationship adjustment through the twelve-month follow-up.  When we added relapse intervention to that, that improvement was retained for twenty-four months after treatment.  They got another full year in significant differences on average between pre and post-treatment.  Again, these are not direct comparisons between conditions; it’s just a within-group examination.  Importantly, they also found that the strongest difference between favoring BCT plus relapse prevention over BCT alone was found among distressed couples.  

Onto community reinforcement and family training; there were three trials we located that looked at CRAFT, and they all compared CRAFT to an alternative family intervention.  Unfortunately, because of differences in how they defined treatment initiation, we elected not to conduct meta-analyses on these studies.  What I can tell you is that each study reported improvement at initiation when comparing CRAFT to another family intervention by thirty to forty-eight percent, so there was a thirty to forty percent improvement in initiation among those participating in CRAFT versus an alternative approach like Al-Anon.  However, importantly there were also no significant differences in substance use across the two trials that reported that data and no significant differences in couple or family functioning across the two trials that reported that data.

Finally, there were two additional opioid interventions.  This was a family intervention compared to an individual intervention; the participants were men who used heroin, who had a pregnant intimate partner who was seeking treatment for an opioid addiction.  This is a dual-use heroin-using couple, and what they found is that the men who participated in a package of interventions that included couple therapy actually used greater heroin use and provided less partner support than men who had participated in a package that did not include couple therapy.  Importantly, this was the only clear negative effect we found across the family interventions we reviewed.  We did find examples when there were no differences between family interventions and alternative, but this was the only true negative finding besides higher rates of drop-out, which I mentioned previously and we’ll come back to for our PTSD study.

Secondly, there was another trial for opioid-dependent patients who added couple therapy to a contingency management program.  They found that when you add couple therapy to contingency management, you improve family functioning but not substance use.  That’s a lot of information, so I just want to take a minute to step back and provide an overview, and also our ratings of efficacy and evidence for each of the interventions that we reviewed.  Now, some important caveats about this table; the purpose of this table is to highlight potentially efficacious and efficacious interventions.  Those interventions we reviewed that found no differences are not included in this table.  This is just to highlight some of the things that we think look like they may be working and what the limits of that information are.  

The first are the BCT studies and the iterations of these BCT studies.  This first line is behavioral couple therapy compared to individual behavioral therapy.  Across the range of studies we rated the efficacy of these studies as both efficacious and specific, so they were different across multiple labs in these outcomes.  However, we rated the evidence at moderate rather than high.  There were a lot of studies here, but a lot of them were done in the same lab.  For that reason we ranked the evidence as moderately confident that the estimates of the difference between BCT and individual therapy on these outcomes are likely to be stable with further research.  Then I mentioned the BCT plus relapse prevention versus BCT; there was one study suggesting that it improved substance use, so we ranked that as possibly efficacious and specific, but given the mixed findings in one study the strength of the evidence here is low.  Same for behavioral family therapy versus individual therapy, that it seems to be in one study possibly efficacious and specific, but the strength of evidence is low.

Then here are the additional interventions; there’s the community reinforcement and family training compared to alternative family intervention, which seems to be clearly efficacious and specific to these family interventions at improving treatment initiation.  We ranked that as well as moderate due to the limited—there are only three studies, and they were mixed in terms of their quality.  Again, there were no differences here.  Also, this is the key question one study we reviewed, which compared family involvement in after care to detox only and found improvements in treatment engagement; they ranked that as possibly efficacious.  And then this is the opioid study that added couple counseling to a contingency management approach and found greater family functioning, but again one trial; we’re talking that this is possibly efficacious and specific and low strength of evidence, and no differences importantly on substance use.

The good news is that is the lion’s share of the articles.  At this point, there are thirty-nine trials to review, and we have gone through twenty-nine, I believe.  The remaining trials are a few trials for different conditions.  First is bipolar disorder.  We located five trials; four of them evaluated family-focused treatment, which is a nine-month psycho-educational intervention that includes education on bipolar disorder, communication training, problem solving for individual patients and their family members.  What we found overall for family-focused treatment, it appears to be superior to less intensive treatments but no different from equally intensive interventions, and by no different of course I mean not statistically significantly different.  As I mentioned, there were four trials; they had better symptom response than alternative family interventions in two trials that mixed differences when compared to equally intensive individual therapies.

There was one trial that did not look at FFT, and it compared two different family interventions and found no differences in recover rates.  Importantly for the FFT studies, we talked about these studies narratively, but we did not pool this data because of the vast different comparisons that were between the interventions in these four trials, and you’ll see this here.  Across these four trials, here is the same table that we looked at with substance use.  These are the initially efficacious and-or specific treatments.  For bipolar disorder all the action is with this family-focused treatment.  This is a variant on FFT which addresses both caregiver and patient needs; FFT focuses on patients.  [Girls], you can see there were a number of different comparisons, so we couldn’t really collapse across these.  Ultimately we found that FFT, or this health-promoting intervention, was possibly efficacious and specific therefore in one trial in improving symptoms when compared to these interventions.

Thus, individual psycho-education is a more intensive intervention.  These are also evidence-based intensive interventions that show no differences in a trial that actually was looking at a number of evidence-based treatments for bipolar disorder and had small groups in each of these treatments, but there were no differences among those.  Now, schizophrenia; there were four trials here and some important context here.  Prior to the one review I mentioned that was comprehensive that was done in ’98 of mental health treatments that were family involved, they concluded, using the same criteria we did, that behavioral family therapy and supportive family therapy for schizophrenia were efficacious.  Since that time, in the U.S. there have only been four additional trials.  We think that part of this reason is for that exactly, that these family treatments have been established as efficacious.  But there certainly is more work that needs to be done here.

These four trials are kind of what, if you want to call the next generation of interventions.  They’re long-term interventions; they’re comparing active treatments to active treatments that are done with complex patients, and as a result there are a lot of mixed findings.  While these kinds of studies are important, these four trials have not dramatically moved forward the literature.  Because of these mixed findings, it’s hard to draw a lot of conclusions.  I’ll review them briefly.  There was one trial that compared a family intervention to an individual intervention with mixed findings.  There were some good outcomes one year in each treatment, and this is a two-year intervention.  Multi-family groups had greater declines in negative symptoms and lower rates of state hospitalization one year into this two-year treatment.  However, one year after the two-year treatment—this is three years plus randomization—there were no differences in hospitalization or use of crisis care.

The other three trials compared intensive to less intensive family interventions, and again, mixed findings; no differences in symptoms across two of the three trials, no differences in rates of hospitalization across two of the trials that reported that data.  One study did measure family adjustment; only one of these four trials looked at that or has presented data on that in the study that we were able to locate.  It found mixed findings in terms of the intensive intervention leading to greater family adjustment and also significant differences favoring the intensive treatments in employment for one trial, but these differences eroded by the final assessment and in schizophrenia symptoms for dual-diagnosis patients, but not lower rates of substance use.

Here is our summary table again; these are the three interventions that showed some level of possible efficacy.  We have multi-family groups compared to individually oriented care, does appear possibly efficacious and specific in improving symptoms and state hospitalizations but not any hospitalizations; one trial, so low strength of evidence.  Applied family management versus a family intervention; this is what I meant by the mixed results in family adjustment.  There were no differences in overall family adjustment, but it does appear to be possibly efficacious and specific in improving patient rejection.  But again, the strength of evidence is low.  Finally, this family intervention for dual diagnoses; this was a schizophrenia and substance use disorder patients compared to short-term psycho-education, and it did result in significant improvements in schizophrenia.  So it’s possibly efficacious and specific at improving symptoms but no differences in substance use and low strength of evidence due to the single trial.

There were these three disorders that were looked at in single trials, and in each case they compared a family intervention to a single intervention without family involvement and found no differences between those two active treatments.  Importantly, as I mentioned, the PTSD study did have an arm that compared exposure therapy to exposure therapy followed by a course of behavioral family therapy, and that combined extended intervention did result in higher rates of drop-out.

Our overall conclusions; basically since 1995, outside of the substance use literature it appears that the literature in the U.S. is largely underdeveloped.  Outside of behavioral couples therapy and CRAFT, many trials did not include or at least did not report on important couple and family functioning outcomes, treatment adherence, satisfaction with care, or even often quality of life.  There’s a lot more we need to know about these interventions.  In many cases, we found mixed findings that either favored family treatments or demonstrated non-significant differences.  Importantly there are two exceptions to this pattern of no differences or favoring family treatment, and that is, as I mentioned, greater drop-out amount for those in the exposure therapy followed by behavioral family therapy, and for that dual-diagnosis heroin-use study where both individuals were using heroin, and men who participated in an intervention that included couples counseling used more and were less supportive of their partners. 

Talking about the interventions that we found some efficacy for, the BCT or BFT in our pooled analyses appears to clearly improve substance use in relationship adjustment compared to individual therapy.  However, most of the trials reviewed in this area were conducted by the same research group, and they excluded participants where the family had a substance use disorder.  Then for community reinforcement and training, it appears to improve treatment initiation, which was an immediate outcome of interest over other family treatments.  The differences in substance use and family functioning were non-significant.  I think it’s important to highlight here that CRAFT was designed to promote initiation, so future research and future clinical work needs to pair this intervention with evidence-based treatment to ensure that those who get funneled into treatment when their families participate in CRAFT, they get funneled into an evidence-based treatment that’s going to ensure adequate treatment response.

For bipolar and schizophrenia we found that FFT or FFT health-promoting intervention results in better symptom response in alternative, less intensive interventions across two trials but mixed differences when you compare it to an equally intensive intervention.  Importantly, across the four bipolar disorder studies no family outcomes were reported.  For schizophrenia the efficacy of family treatments were established prior to this review, so that might have been part of the reason why so few U.S. studies were found.  In the studies that we did review included complex cases that had multiple diagnoses or problems; often two of the four explicitly recruited people with multiple problems.  There also were long interventions and compared active interventions to other active interventions, but because of the difficulty with these kinds of trials perhaps, they provided little clarity regarding which family interventions are best.

Overall, there were many limitations among the trials we reviewed.  Most were fair to poor quality; most were done with white male samples under forty.  Most included participants with a co-occurring substance use, a clinical crisis, or history of family or partner violence.  While two studies for schizophrenia required complex cases, the rest of the studies did not explicitly exclude patients with co-occurring problems or disorders, but they didn’t stratify results that way either.  Finally, most studies did not report on the veteran status of their participants.  Big take-home point is that the applicability of these trials to veterans and to complicated patients is largely unknown.  While our study has a number of benefits, we tried to look at studies across the gamut of mental health so we could compare the evidence across disorders.  We focused on interventions that were recent and those which applied most to veterans, but each of those benefits is a double-edged sword.  We couldn’t speak much to our first key question about the general efficacy of interventions because we didn’t really have many studies, and we suspect that most of those studies were done prior to ’96.

There have been a number of studies conducted outside of the U.S. that we cannot speak to, especially in schizophrenia, especially in China.  But also the applicability of these trials to U.S veterans is unknown.  Also, we only looked at RCTs, so there are a number of family interventions in various stages of development.  And development of these interventions is hard work, so we certainly acknowledge that and look forward to when these interventions get to the point where we start seeing some randomized clinical trials published.  Finally, we focused on patient outcomes of interest.  There are caregiver interventions; there are reviews of caregiver interventions.  Family perspectives on our outcomes are critical but were really outside of the scope of our review.  

I already highlighted some points for future research; the other points I would make are that we need more randomized clinical trials of veterans and among those studies with few trials, we need to look at to what degree family interventions may be more effective with distressed couples.  There were a number of studies which did secondary analyses finding that couples that were more distressed did better in the family conditions than they did in the alternative arms of these trials, so we need some more research on that.  We need to expand our RCTs to address multiple problems and conditions, like non-white samples, females, older populations, and we need to look more at the patient preferences for individual versus family-oriented treatments and methods of motivating family and veterans for patient-centered care.  Finally, we need more trials on alternative family and couple constellations.  That includes roommates, extended family members, non-residing family members, and same-sex couples.

That is where I will wrap up, and I think we can go ahead and start taking some questions.

Moderator:  We might want to open up the panel to either Dr. Greer or Dr. Glynn for any comments.  Dr. Glynn, would you like to start?

Shirley Glynn:  Just a couple of thoughts; one is, I told Laura before we started out how impressed I was with the comprehensive nature of this.  I just really think the team has done an outstanding job, particularly because it’s so complicated in terms of dual outcomes and such like that.  I just wanted to make sure people on the call knew that based in part on this synthesis, the VA is disseminating two new family interventions.  One is behavioral couples therapy for substance abuse, Tim O’Farrell’s model, and the first training for that will be in August.  We’re also going to do a pilot on cognitive behavioral couples therapy for PTSD.  Many of you know Candace Monson’s work, which was not included here because her trial was just finishing.  But we’re going to do a pilot rollout of that in January.  I guess my point is I want you to know that we take the results seriously.

Moderator:  Thank you very much for that.  We’ll jump right into the questions.  For the lab conducting the majority of studies which may be underestimating the treatment of [inaudible], could you describe the samples recruited to that lab?

Laura Meis:  Yes.  They did very diverse work.  I would say there’s one trial that was the same-sex couples trial; most of them are pretty consistent with the larger literature though, that they tend to be mostly intimate couples.  Sometimes they did married; they did unmarried.  There wasn’t anything particularly unique about their sample.  They’re located in upstate New York, so some of the samples may be influenced by that.  There wasn’t anything particularly remarkable about their samples that were different from the larger BCT literature.

Moderator:  You mentioned that more information about couple therapy for PTSD will be coming out in January.  Where can we find more about that?

Shirley Glynn:  Basically all the dissemination of the family services programs are done through the EBT coordinators.  We also have a family-services Web site.  Anybody can email me, and I’ll email you the family-services Web site if you don’t have that.  We always announce our trainings there.  The most important thing is to talk with your EBT coordinator because typically all the trainings are announced about three months before we have them, maybe three and a half months.  It’s a competitive process to apply, particularly for CBCT.  It’s going to start out as a pilot, so we’ll be small.  We’ll really only be taking probably twenty-five people the first time for any number of reasons.  You could always keep in touch with your EBT coordinator, and he or she will have the information on what’s available and how to apply.

Moderator:  The next question, please discuss the wait-list intervention.  I’m not sure what this is.

Laura Meis:  Good question; I did kind of skip through that pretty quickly.  Our key question, which was the efficacy question, we were looking at interventions and the spirit of it was comparing a family intervention to no psychosocial intervention in a randomized way.  Individuals were randomized into a no-treatment group or a family treatment group.  That no-treatment group could be medication management.  In most cases, it was a wait list.  That means that the patient was eligible to receive the family intervention after a certain time point, and before that time point they measured how they were doing.  So they had, in effect, an appropriate comparison that they could compare people who did this family intervention to people who were getting no treatment.  But due to ethical reasons, a lot of times with these mental health treatments they want to then offer the patients who are willing to do these wait-lists to then get treatment after that point.

Moderator:  I invite either you or Dr. Glynn to make some more comments.

Shirley Glynn:  A couple things I would say in looking at this literature, and issues which we continue to struggle with, which you don’t see reflected here as much as we would perhaps wish in terms of research development right now; anybody on this phone doing family work knows our biggest challenge is engagement.  Aside really from the CRAFT intervention and a newer intervention that we’ve just designed—our team has been working with Lisa Dixon about a brief family engagement intervention—it’s been very challenging for us.  I think the issue in most of the interventions we talk about is what if you gave a treatment and nobody came, because we have a horrible time really getting people into treatments.  

I think when you think about that, if you’re interested in mounting any of these treatments and getting help with dissemination either through our rollouts or through other training you’ve had, or if you’re going to seek special consultation, I want to emphasize that at least as much attention should be paid to how you’re going to publicize your program, how you’re going to actually make sure first contacts with you, with families, and veterans are positive because throughout pretty much all our rollouts and all these studies, you’ll see we have to approach a lot of people to get a sufficient sample size for any of these studies to work out.  That’s an area of continuing concern and engagement and research interest in our part.

 I think the other thing that’s not represented here much but there’s quite a bit of interest now is using these interventions with telehealth modalities.  There have been a few studies; for example, there’s one VA researcher, Armando Rotondi, who’s done some work with family interventions using telehealth, particularly online training programs.  We’ve done a little bit of that as well in our lab.  There are obviously two ways to go about it; there’s sort of the VA way, which is telehealth through [C-BOX] or whatever to just do an evidence-based treatment, whatever evidence-based treatment there is.  There are groups now doing that; for example, family-focused treatment that Laura talked about in Denver.  There’s also a whole other movement which is trying to develop interventions that are more tailored to use of newer technologies.  For example, the family coach out of the National PTSD Center, these other interventions where you can basically log on and have people get materials either through discussion times, real-time simultaneous chat.  

I think this is the other way; now, that’s hard on the VA, we all know, because of the security issues, although there are some groups working on that here.  And I do think that’s an additional area where we’ll see more and more development.  I think the final thing that we’re all sort of struggling with here is for those of us who see more troubled veterans—and here I would say people who are severely disabled by depression, schizophrenia, bipolar illness, or PTSD to the point where, for example, perhaps they’re unable to work; they have very limited social networks and those sorts of things.  Our models have been sort of limited in how to work with these folks in a marital relationship.  Many of the interventions have been designed, aside from the substance abuse ones, have been equally applicable to family of origins or couples.  

Thinking about how to take some of these interventions and make them really applicable to couples work and the challenges of divorce and separation, ambivalent connections in the families, that’s another area where I think we’re really trying to struggle.  I think that accounts for some of the mixed results in some of these studies and to be sort of thoughtful about that because sometimes when we take these manuals, they assume that there’s a level of commitment in the couple that maybe there isn’t.  And so learning how to attend to that and make sure that you can monitor that, bolster that, or make a decision about is this the right time?  Does the couple have enough of a commitment?  That’s the time to use one of these EBPs.  It’s really a critical one.  I think that’s everything I would say.

Moderator:  Thank you very much for those comments.  It’s very helpful for the field to hear what needs to be done and what more is to come.  Dr. Meis, would you like to make any concluding comments?

Laura Meis:  I just agree largely with what Shirley said, that I was also surprised that there isn’t a lot done in terms of getting patients motivated to do family interventions.  That’s kind of an important and large gap.  Also, I think that, like I mentioned, there’s some potential for family interventions to help keep people in treatment as well as initiate treatment.  [Inaudible] questions about to what extent these family interventions may be even more indicative with distressed families.  But in those cases it’s even more complicated because clinically, if you’re working with a veteran who comes in your door who may be an excellent candidate for a couple intervention, and may be especially indicated because those who are in distress may do better in that family intervention.  

Again, engaging that veteran and inviting that family member into treatment is complicated and also the degree to which clinicians within the VA do or don’t have family treatment experience and feel comfortable inviting what may be a very unhappy couple into their office is also a complicated issue in terms of how to implement this within the VA.

Moderator:  We have had a few more questions come in.  Can you describe the CRAFT method in a little more depth, please?

Laura Meis:  Yeah.  It is an intervention that is done just with family members.  If a family member of a patient—it’s kind of weird to describe it that way, but essentially if you as an individual know that your uncle, or your father, or you husband, or your wife has a substance use problem and you want to get them into treatment but you don’t know how, this intervention is to help with that.  It provides support, but it also does some basic training on how to not enable your loved one and how to talk to them about treatment in a way that is not shaming or blaming.  It kind of has a little bit more of a feeling of an MI approach in terms of how to talk to family about how to talk to their loved one so that they’re not nagging and blaming and shaming but helping in a more productive way to bridge their family member into treatment, and also get their own support.  I guess that’s a better overview of treatment.  I hope that that’s helpful.

Moderator:  Thank you.  There is a comment, and they want us to say thank you for mentioning Al-Anon; this is very important.  The next question, forgive my ignorance with this literature. Is there any research on motivational interviewing, targeting a family unit just as an individual in terms of promoting engagement?

Laura Meis:  I’m guessing what they mean is a motivational interviewing approach towards a family member, with or without the patient?

Shirley Glynn:  Laura, would you mind if I said something about that?  

Laura Meis:  Go for it.

Shirley Glynn:  I just alluded to one intervention that we are just finishing up.  It’s a large trial in the L.A. and Baltimore VAs where we use people just coming in from the mental health clinics, veterans with depression or schizophrenia essentially.  What we were interested in doing, and what I think is a formidable gap that is not reflected in this work but is a formidable gap, is just connecting families up with treatment teams, not trying to get them in for six months’ or a year’s worth of service, but just getting them so they feel like they have an avenue to access to the treatment team.  What we did there, which speaks to this issue of MI, is we first start with the veterans, and all the veterans had to do was say they had a family member.  They didn’t have to want their family members in treatment.  In fact, their family members were not.  

We did a three-session MI-focused intervention with the veterans to try to encourage them to be interested in inviting their family members in for care; first of all, activating the veteran to invite the family members into care.  By doing that we were able to encourage, I think it’s around sixty, seventy percent of the veterans to agree to invite their family members into care.  Then the family members came in; they did one session without the veteran, and a big part of that session was engagement again.  Then we did MI with the family members, trying to encourage them to put energy into developing a relationship with the treatment team.  We did all the regular MI activities, decisional balance, that sort of thing, and then also had them role play: calling the treatment team, having specific questions, addressing issues of confidentiality, that sort of thing.  

Some of the family members could then go on and ask for EBTs for “I heard you had behavioral family therapy or couples therapy or whatever,” and they could ask that.  But we were just trying to activate them to engage with the team.  Aside from substance abuse, this is one of the first interventions that I’m aware of that’s using MI both with the veteran and with the family members to try to get them more interested in sort of being involved in treatment.

Moderator:  Our questioner did write in and say that you did hit the nail on the head.  You answered exactly what they were going for.  Dr. Meis, I do want to give you the opportunity if you did want to add anything to that.

Laura Meis:  I have nothing to add to that.  I agree with Shirley that it’s just in the substance use that I’m aware of and that really excellent trial that she and Lisa did that was not published at the time of our search.

Moderator:  We do have two remaining questions.  Was IBCT studies explored integrative behavioral couples therapy?

Laura Meis:  That’s also a very good question.  I’m guessing they mean for the systematic review.  For the systematic review we narrowed the scope to mental health conditions.  If the family intervention didn’t address a DSM-level mental health condition, we did not address it.  That was just a practical decision in terms of what we can really dig our teeth in into this review and provide something that’s helpful, and due to the existing reviews for couples therapy broadly.  So we did not address interventions that targeted couple distress or family distress and did not look at alternative mental health outcomes.

Moderator:  We do have one remaining question that I would like to get to.  Before we do, I just want to remind our attendees that we do record all of our sessions, and we have many past and future sessions on mental health, so you can always go to the HSR&D homepage and look for cyber seminars to access all of those and register for future ones.  The final question, can you provide a good resource to introduce the novice to group and/or individual psychosocial behavioral therapy addressed in the studies?

Shirley Glynn:  Here’s the deal; I don’t think there are wonderful texts that you can go to that address everything because what you hear from Laura is that most of the things are disorder specific.  Generally you need to, say, go into schizophrenia or go into substance abuse or that sort of thing.  I’m not actually aware of a text that broadly says, “Here’s everything you need to know about family work across a variety of diagnoses.”  Now, Laura, you may know something, but I tend to know more about diagnosis.

Laura Meis:  No, I agree with that.  I think that there are texts that have chapters about family treatments for mental health conditions, like broad couple therapy handbooks do have chapters on family therapy for schizophrenia and family therapy for bipolar disorder.  But if you actually want to learn how to do it, you’re right; it seems to be so far very disorder specific.  It’s easier to pick up a manual on how to do therapy x for disorder y than how to do these things broadly.  Of course, there are texts on how to do couples and family therapy if your intention is to improve couples and family functioning, and there are broad texts on that.  But if your goal is to improve mental health, then it does seem to be pretty specific.

Moderator:  Thank you very much.  That was our final question.  If you have anything you’d like to add, this would be the time.

Laura Meis:  Just thank you so much to everyone for your interest in this topic and for moving forward the VA interest in family involvement.

Shirley Glynn:  I second that.

**End of recording**