Clinical Effectiveness and Cost-Effectiveness of Supported Mindfulness-Based Cognitive Therapy Self-help Compared With Supported Cognitive Behavioral Therapy Self-help for Adults Experiencing Depression

Abstract

ImportanceDepression is prevalent. Treatment guidelines recommend practitioner-supported cognitive behavioral therapy self-help (CBT-SH) for mild to moderate depression in adults; however, dropout rates are high. Alternative approaches are required.ObjectiveTo determine if practitioner-supported mindfulness-based cognitive therapy self-help (MBCT-SH) is superior to practitioner-supported CBT-SH at reducing depressive symptom severity at 16 weeks postrandomization among patients with mild to moderate depression and secondarily to examine if practitioner-supported MBCT-SH is cost-effective compared with practitioner-supported CBT-SH.Design, Setting, and ParticipantsThis was an assessor- and participant-blinded superiority randomized clinical trial with 1:1 automated online allocation stratified by center and depression severity comparing practitioner-supported MBCT-SH with practitioner-supported CBT-SH for adults experiencing mild to moderate depression. Recruitment took place between November 24, 2017, and January 31, 2020. The study took place in 10 publicly funded psychological therapy services in England (Improving Access to Psychological Therapies [IAPT]). A total of 600 clients attending IAPT services were assessed for eligibility, and 410 were enrolled. Participants met diagnostic criteria for mild to moderate depression. Data were analyzed from January to October 2021.InterventionsParticipants received a copy of either an MBCT-SH or CBT-SH workbook and were offered 6 support sessions with a trained practitioner.Main Outcomes and MeasuresThe preregistered primary outcome was Patient Health Questionnaire (PHQ-9) score at 16 weeks postrandomization. The primary analysis was intention-to-treat with treatment arms masked.ResultsOf 410 randomized participants, 255 (62.2%) were female, and the median (IQR) age was 32 (25-45) years. At 16 weeks postrandomization, practitioner-supported MBCT-SH (n = 204; mean [SD] PHQ-9 score, 7.2 [4.8]) led to significantly greater reductions in depression symptom severity compared with practitioner-supported CBT-SH (n = 206; mean [SD] PHQ-9 score, 8.6 [5.5]), with a between-group difference of −1.5 PHQ-9 points (95% CI, −2.6 to −0.4; P = .009; d = −0.36). The probability of MBCT-SH being cost-effective compared with CBT-SH exceeded 95%. However, although between-group effects on secondary outcomes were in the hypothesized direction, they were mostly nonsignificant. Three serious adverse events were reported, all deemed not study related.Conclusions and RelevanceIn this randomized clinical trial, practitioner-supported MBCT-SH was superior to standard recommended treatment (ie, practitioner-supported CBT-SH) for mild to moderate depression in terms of both clinical effectiveness and cost-effectiveness. Findings suggest that MBCT-SH for mild to moderate depression should be routinely offered to adults in primary care services.Trial Registrationisrctn.org Identifier: ISRCTN13495752

Overcoming the Scourge of Missing Data in Psychotherapy Trials—Reply

“…An exploratory sensitivity analysis using this revised data set confirmed the superiority of practitioner-supported mindfulness-based cognitive therapy self-help (MBCT-SH) over practitioner-supported cognitive behavioral therapy self-help on the primary outcome (Patient Health Questionnaire 9) at 16 weeks postrandomization with a between-group difference of −1.4 points (95% CI, −2.4 to −0.3; P = .009; Cohen d = −0.34). This result is almost identical to that arising from the primary, preregistered analysis yielding a between-group difference at 16 weeks postrandomization of −1.5 points in favor of practitioner-supported MBCT-SH (95% CI, −2.6 to −0.4; P = .009; Cohen d = −0.36) . Although we agree that trial data may be more likely to be missing for people who fared poorly, our reanalysis suggests that this risk is not different between trial arms.…”

“…Although we would welcome efforts to reduce missing data, as we discuss in our article, we suggest that session-by-session service-collected data in services such as NHS Talking Therapies serves an important but different purpose to data collected in clinical trials. The purpose of session-by-session data in NHS Talking Therapies is to monitor progress and guide and adjust intervention planning, and thereby serves a crucial role in improving recovery rates.…”

Overcoming the Scourge of Missing Data in Psychotherapy Trials

“…To the Editor The recent clinical trial by Strauss et al in the May 2023 issue of JAMA Psychiatry suggests that mindfulness-based guided self-help may be a useful additional therapeutic option for mild depression.…”

“…This is surprising as the study was conducted using England’s NHS Talking Therapies for Anxiety and Depression (formerly known as Improving Access to Psychological Therapies) services, which mandate session-by-session outcome monitoring and achieve a missing data rate of only 2% among all the patients who have a course of treatment, including those who only have an intake assessment and then drop out after attending their first therapy appointment . Strauss et al did not build into their research design access to the services’ routinely collected data. Consequently, they are missing data from most people who dropped out early in treatment and are likely to have fared poorly.…”

Error in Byline

“…In the Original Investigation titled “Clinical Effectiveness and Cost-effectiveness of Supported Mindfulness-Based Cognitive Therapy Self-help Compared With Supported Cognitive Behavioral Therapy Self-help for Adults Experiencing Depression: The Low-Intensity Guided Help Through Mindfulness (LIGHTMind) Randomized Clinical Trial,” published on March 22, 2023, there was an error in the byline. The academic degree for Amy Arbon was updated to MPhil.…”