RCT of a positive psychology intervention for people with newly diagnosed HIV

Update April 22, 2017 8:00 As written, my post praises the trial for having being pre- registered and having a published protocol. That is expected for health psychology interventions, but  unusual in the  positive psychology literature. However, James Heathers pointed out on my Facebook page that the protocol was published 6 years after the study began. The earlier registration does not indicate the 25 outcome measures that were examined. Next time, I’ll be more careful and less trusting.

Protocols for RCTs should be published before the first patient is recruited. Not having the protocol published then opens a study to all kinds of questionable research practices -like  hiding, or switching or introducing new outcomes. I am disappointed in these investigators. 

This edition of Quick Thoughts provides a quick critical review of a positive psychology intervention for people newly diagnosed with HIV.

The trial is unusual in evaluating a positive psychology intervention in a trial with registration with published protocol.

However, the trial is ambiguously a null trial. By any conventional standards, it does not offer encouragement to pursue this line of research. The authors acknowledge in passing that is a null trial but seek to undermine that perception with presentation of results that are not significant when the multiple post hoc testing is taken into account.

  • Problems in the trial are consistent with a lot of clinical health psychology interventions:
  • Patients are asked to complete a battery of multiple, redundant outcome measures, which are a burden, but allow the investigators flexibility in picking and choosing what to emphasize in spinning results.
  • The intervention is relatively intensive, with multiple meetings required. However, new skills or techniques are presented almost every session, allowing no time for development of skills before going on to the next skill. So, the intervention is intensive, but exposure to particular coping skills is weak.
  • It is doubtful that there will be much uptake of this intervention in clinical practice with a relatively low income people who have just been told they have HIV are not being compensated. Studies like this have reasonable recruitment and retention in low income populations because low income people need the money. The benefit (or lack thereof) shown this trial would not justifying paying people to come.
  • At some point, we need to ask: for whom do we do clinical health psychology studies: patients in need of services or investigators in need of publications and justifications for the next grant?
  • This trial is not well justified in terms of benefit to patients and the explicit public health message that it shows the “promise” of such intervention package is not warranted/

The randomized trial

Moskowitz JT, Carrico AW, Duncan LG, Cohn MA, Cheung EO, Batchelder A, Martinez L, Segawa E, Acree M, Folkman S. Randomized Controlled Trial of a Positive Affect Intervention for People Newly Diagnosed With HIV. Journal of Consulting and Clinical Psychology. 2017 Mar 23.

Objective: We conducted a randomized controlled trial to determine whether IRISS (Intervention for those Recently Informed of their Seropositive Status), a positive affect skills intervention, improved positive emotion, psychological health, physical health, and health behaviors in people newly diagnosed with HIV. Method: One-hundred and fifty-nine participants who had received an HIV diagnosis in the past 3 months were randomized to a 5-session, in-person, individually delivered positive affect skills intervention or an attention-matched control condition. Results: For the primary outcome of past-day positive affect, the group difference in change from baseline over time did not reach statistical significance (p = .12, d = .30). Planned secondary analyses within assessment point showed that the intervention led to higher levels of past-day positive affect at 5, 10, and 15 months postdiagnosis compared with an attention control. For antidepressant use, the between group difference in change from baseline was statistically significant (p = .006, d = −.78 baseline to 15 months) and the difference in change over time for intrusive and avoidant thoughts related to HIV was also statistically significant (p = .048, d = .29). Contrary to findings for most health behavior interventions in which effects wane over the follow up period, effect sizes in IRISS seemed to increase over time for most outcomes. Conclusions: This comparatively brief positive affect skills intervention achieved modest improvements in psychological health, and may have the potential to support adjustment to a new HIV diagnosis. (PsycINFO Database Record (c) 2017

The study was registered with Clinicaltrials.gov (#NCT00720733.) and the protocol is here.

The primary outcome measure is positive affect. Our first aim is to determine the efficacy of the intervention for increasing positive affect at Times 2, 3, and 4. The second aim tests positive affect as a mediator of intervention effects on psychological well-being (eg, depression), health behaviors (eg, HIV transmission risk, engagement in care, medication adherence) and physical health (eg, CD4, viral load, symptoms).

Intervention

The IRISS intervention consisted of five in-person sessions and one phone session in which facilitators taught participants eight empirically supported behavioral and cognitive skills for increasing positive affect.

The intervention is summarized in a table.

folkman intervention table

Control condition

Participants in the control condition also had five one-on-one sessions with a facilitator, followed by a sixth session by phone, producing a time/attention-matched comparison condition. The sessions were comparable in length to the intervention sessions (approximately 1 hr) but consisted of an interview and did not have any didactic portion or skills practice. These sessions were designed to remove the positive affect component of the intervention, while maintaining any nonspecific effects arising from one-on-one contact with a sympathetic facilitator to share one’s personal stories and concerns.

Results

Results for psychological variables are summarized in the table below. Pay attention to the treatment x time interaction. Significance in that statistic indicates that there is an overall significant difference that can be examined in post hoc exploratory analyses. Nada, nada, all null findings despite a large number of variables being examined without correction for multiple testing.

folkman results

Beware of investigators who shift to reporting 3 digit significance levels for a secondary outcome when they are having trouble coming up with any significant differences at all.

.048

What do we make of the difference in antidepressant prescription?

Participants assigned to the control condition had a substantial increase in their antidepressant prescriptions, but not for anxiolytics. What should we make of this? Probably not much, given the multiple testing going on. But I have done trials of  interventions to improve adherence with patients with HIV/AIDS.

The rates of antidepressant prescription reported in the present study are consistent with what we observed in our study. I doubt that the prescriptions are appropriate or receive adequate follow up. It’s a common, but not evidence-based practice for infectious disease specialist trained in internal medicine, but not psychiatry, to freely provide antidepressant prescriptions without even making a formal diagnosis or asking more than a question or two.

What clinical and public policy significance do the authors claim for the study?

public health significance for Folkman study

I wish these kind of studies had a higher level of patient involvement from the outset and continuing through the write up and interpretation of data. I doubt that a investigator group that involved and listened to patients would come up with this kind of design or make these kind of recommendations, given the results that were obtained.

eBook_PositivePsychology_345x550I will soon be offering e-books providing skeptical looks at positive psychology, as well as mindfulness. Sign up at my new website to get advance notice of the forthcoming e-books and web courses, as well as upcoming blog posts at this and other blog sites.  Lots to see at CoyneoftheRealm.com.