A 12‐session relapse prevention program vs psychoeducation in the treatment of Japanese alcoholic patients: A randomized controlled trial

Abstract Aim Alcoholism is the most prevalent substance use disorder in Japan; the estimated number of patients and high‐risk drinkers is in the millions. Although studies in the West have shown that cognitive behavioral therapy (CBT) is one of the most effective treatment strategies for alcoholic patients, there is a dearth of efficacy studies of CBT‐based intervention for those patients in the non‐Western setting. The aim of this study is to investigate the efficacy of a 12‐session CBT‐based relapse prevention program for Japanese alcoholic patients. Methods Forty‐eight alcoholic patients (M = 36, F = 12) who were admitted to an addiction treatment unit were randomly allocated either to a 12‐session relapse prevention (RP) program (n = 24) or a 12‐session psychoeducation (PE) program (n = 24). Both treatment programs were conducted in a group format once a week for 12 weeks. Other aspects of inpatient treatment (group meetings, etc) were the same in both groups. Self‐rating scales, which measure behavioral and cognitive coping, coping response, self‐efficacy, and cognition of drinking, were administered at pretreatment, mid‐treatment, and posttreatment periods. The proportion of participants who relapsed at 3 and 6 months after discharge was evaluated. Results Both RP and PE groups showed significant improvement in self‐efficacy and cognition of drinking at posttreatment. However, there were no significant differences in the self‐rating scales between both groups. In addition, there were no significant differences in relapse rate at 3 and 6 months after discharge between both groups. Conclusions The 12‐session CBT‐based relapse prevention program and the psychoeducation program may be equally efficacious for alcoholic patients. Several factors that influenced the results are discussed.


| INTRODUC TI ON
Alcohol dependence is one of the most prevalent public health concerns in Japan. In Japan, it is estimated that more than 4.5 million people are considered to be problem drinkers and 800,000 meet the criteria for alcohol dependence of the ICD-10 Classification of Mental and Behavioral Disorders. 1 However, only 40,000 patients are currently under treatment, and the most common treatment approach, except for self-help groups, is pharmacologic, while cognitivebehavioral or relapse prevention strategies are rarely used. 2 Previous studies have shown that cognitive-behavioral therapy (CBT) is one of the most effective treatment strategies for alcoholic patients. 3 From the CBT perspective, alcoholism is viewed as not only a disease but also a set of learned behaviors. 4 For example, alcoholic patients are likely to use alcohol to alleviate their negative emotions. Through repeated experiences where alcohol works to provide the desired effects, drinking becomes the only way to achieve them. Moreover, in the learning process, originally neutral stimuli are associated with drinking and they work as triggers to drinking.
The relapse prevention (RP) model is a CBT-based treatment approach targeting substance abuse and addictive behaviors. The major goal of RP is to address the problem of relapse and to generate techniques for preventing or managing its occurrence. 5 RP has two major steps: (a) identifying high-risk situations or triggers and (b) learning coping skills for these triggers in order to prevent relapse. RP incorporates a variety of treatment elements to prevent relapse and achieve abstinence, including coping skills training, anger management, stress management, and cognitive restructuring. Sandahl and Rönnberg 6 developed a group format for RP and showed its effectiveness for patients with alcohol dependence. Irvin et al 7 conducted a meta-analytic review of RP and found that the overall effect size was r = .14 (95% confidence interval [CI] = 0.10-0.17). A larger effect size was obtained (r = .48, 95% CI = 0.42-0.53) when psychosocial functioning was used as an outcome. According to another recent meta-analysis 8 of the efficacy of CBT for adult alcohol and illicit drug users, CBT produced a small but statistically significant treatment effect (g = 0.15, 95% CI = 0.07-0.24). However, these studies were carried out exclusively in the United States. Furthermore, RP has rarely been conducted outside Western countries. 9 The aim of this study is to investigate the efficacy of a CBTbased relapse prevention program for Japanese alcoholic patients compared to treatment as usual, which includes psychoeducation.
Although psychoeducation (PE) has been one of the core components as well as pharmacological therapy in the treatment of Japanese alcoholic patients, its effectiveness as an active treatment also has not been evaluated in Japan. Therefore, this study also gave us an opportunity to compare the effectiveness between those two active treatments, RP and PE. As far as we know, this study is the first randomized controlled trial of a CBT-based relapse prevention program for alcoholic patients in Japan.

| Participants
Participants in this study were recruited from patients who were ad- Among 49 eligible patients, no patients were excluded, but one patient refused to participate in the study, so the total number of participants was 48. All participants were physically detoxified from alcohol prior to their involvement in the study. At pretreatment, we assessed the severity of alcohol dependence using the Alcohol Use Disorders Identification Test (AUDIT) [12][13][14][15][16][17]

| Randomization
Participants were randomly assigned either to the relapse prevention (RP) program or the psychoeducation (PE) control group. An independent research assistant who was not involved in recruitment and treatment conducted randomization using computer-generated random digit numbers. In randomization, a block design with the size of 4 and 6 was used to minimize the possibility of a chance imbalance of sample size between the groups. Each group had 24 participants. The proportion of women was significantly less in the RP K E Y W O R D S alcoholic patient, alcoholism, cognitive behavioral therapy, psychoeducation, randomized controlled trial, relapse prevention group than in the PE group (4.2% vs 45.8%, χ 2 (1) = 12.57, P < .01), and the mean AUDIT score was significantly lower in the RP group than in the PE group (23.3 vs 27.8, t(23) = 2.05, P < .05). There was no significant difference in other variables between the groups at baseline (Table 1).

| Intervention
The duration of admission in our addiction treatment unit is usually 3 months, and during admission, all participants in both groups were offered the weekly scheduled program: group meetings, physical exercises, occupational therapy (leatherwork), and a family session.
The patients were encouraged to attend Alcoholics Anonymous meetings during the inpatient period and to present their drinking history in a group meeting before discharge. Participants had either relapse prevention (RP group) or psychoeducation (PE group) once a week for 12 weeks in an open group format. Each group had [8][9][10][11][12][13][14][15] participants and each session for both groups was 90 minutes in duration. As the program was delivered continuously, participants who entered at different points of time still covered the full range of topics despite their staggered entry into the program. After discharge, participants were encouraged to receive continuous outpatient treatment.

| CBT-based relapse prevention (RP)
The RP group used a workbook, which consisted of 12 sessions covering self-management to prevent relapse, including identification of drinking triggers, coping skills training, cognitive restructuring, stress management, anger management, and alternative activities.
Moreover, considering Japanese cultural and social characteristics, culturally appropriate components were incorporated including culturally appropriate drinking triggers and coping skills. 2 Facilitators of RP sessions included a psychiatrist, an occupational therapist, and two clinical psychologists. We also developed a fidelity scale for this study and treatment fidelity was checked by at least two staff members.

| Psychoeducation (PE)
Our psychoeducation program consisted of 4 weekly 90-minute sessions, which included the following topics: mechanism and psychological characteristics of addiction, relationships with family members, harmful consequences of addiction, and a roadmap to recovery. The PE group received three cycles of this four-session program repeatedly, for a total of 12 sessions. The program was conducted by two psychiatrists and a clinical psychologist.

| Measurements
To evaluate psychological factors related to treatment effects and relapse, the following four self-rating scales were administered at three points of time: pretreatment, mid-treatment (immediately after the sixth session), and posttreatment.

| Coping Behaviors Inventory (CBI)
The CBI 18 is designed to assess the use of behavioral and cognitive coping strategies of alcoholic patients to cope with craving and high-

| Primary and secondary outcomes
The primary outcome of the treatment in this study was a self-report on relapse at 3 and 6 months after discharge. Relapse was defined as drinking an amount of alcohol that was equal to or greater than that before admission. The secondary outcome was the change in scores between pre-and posttreatment on the four self-rating scales.

| Data analyses
We performed the chi-square test to compare the relapse rates be- The last observation carried forward method for missing data from participants who dropped out was utilized in the ITT analysis. Of the 48 participants, three in the RP group and four in the PE group dropped out by the midpoint assessment after completion of the sixth session. Among those, one in the RP group committed suicide and another in the PE group developed acute psychosis. Furthermore, eight in the RP group and seven in the PE group dropped out between the midpoint and the final 12th session.

| RE SULTS
Therefore, 13 participants in each group completed the program and there was no difference in drop-out rates between the groups. We obtained follow-up data from 15 participants in the RP group and 18 in the PE group at 3 months after discharge, and 15 in the RP group and 20 in the PE group at 6 months after discharge (Figure 1).

| Secondary outcomes
The The CBI score at posttreatment was significantly better than the pretreatment score (P = .008).
The scores for generalized self-efficacy, situation-specific self-efficacy, and expectancy and resignation of DRCS at mid-treatment (P = .004) as well as posttreatment (P = .026) were significantly better than those at pretreatment ( Figure 2). Also, in the subgroup analysis for male patients, there was no significant interaction in [time × group] in those scales.

| DISCUSS ION
This study was the first randomized controlled trial done as a pilot study to evaluate the efficacy of a CBT-based relapse prevention (RP) program compared to psychoeducation (PE) for Japanese alcoholic patients. We did not find that the 12-session RP program was superior to PE in terms of relapse rate at the 3-and 6-month followup periods. Also, although the self-rating scales indicated significant psychological improvement between pre-and posttreatment, and pre-and mid-treatment in both groups, there was no significant difference between them for change of score. Considering that the severity of alcohol use measured by the AUDIT at pretreatment was significantly greater in the PE group than in the RP group, the lack of superiority of the RP program cannot be attributed to the imbalance of the severity of alcohol abuse between the groups.
Our results were inconsistent with previous studies that showed the superiority of RP compared to psychoeducation in treating alcoholic patients. Miller  Note: Relapse is defined as drinking amount of alcohol that was equal of grater that that before admission.

TA B L E 2 Outcome measures at 3and 6-mo follow-up after discharge (ITT analysis)
review reported that RP demonstrated moderate efficacy compared to psychoeducation. 7 The inconsistency between our results and these previous studies may be accounted for by the following points. First, we replaced once-a-week psychoeducation sessions with once-a-week RP sessions in our inpatient treatment program, which itself consisted of multiple programs. Carroll 23 reported that RP appeared to be effective relative to no-treatment control, and equally as effective as other active treatments. Although a meta-analysis of treatment for use of alcohol and illicit drugs showed a large effect size for CBT compared to no treatment, the effect size for CBT plus psychosocial treatment compared to psychosocial treatment alone was negative and insignificant. 8  Notably, we found significant improvement even at the midtreatment point (after the sixth session) in both groups. This finding may suggest that a 6-week inpatient program would be of some benefit for alcoholics. Although a randomized controlled study of RP compared to a 12-step aftercare program showed that the number of RP sessions was correlated to better outcomes in drug use, 25 a meta-analysis indicated that the number of treatment sessions was negatively associated with the effect size. 8 Another study, which evaluated the effectiveness of an inpatient group CBT program for alcohol dependence, showed that the attendance rate of CBT group sessions was not associated with improvement. 26 In Japan, the inpatient period for treatment of alcoholism is usually 3 months. If short-term treatment produces the same effect as longer treatment, short-term treatment would be more cost-effective and may increase motivation for inpatient treatment.
This study includes several limitations. First, by chance, there was a significant difference in the gender proportion between groups. The number of women in the RP group was very small compared to the PE group (1 vs 12). However, in the subgroup analysis of male patients, we did not find any difference in outcomes between the groups. A meta-analysis has suggested that women appear to obtain more benefit from CBT than men do. 8 Therefore, our study may suggest that the effectiveness of RP and PE is comparable in men although it is inconclusive in women.
Second, the primary outcome in our study was the relapse rate and we did not evaluate any other drinking outcomes. Bennett et al 27 failed to detect a significant reduction of recurrence of any drinking as the treatment effect of RP. However, they detected clinically worthwhile improvements in other forms of drinking outcomes including occurrence of any heavy drinking and the frequency and amount of drinking. Even though our findings showed no significant difference between the groups in relapse rate at 3 and 6 months after discharge, there might be differences in other drinking outcomes. We expect further study to include these additional outcomes.
Third, the 6-month follow-up period may be too short to detect any preventive effects of RP. Previous RP intervention studies found no differential outcomes at earlier follow-up, but results favored RP at 9, 12, and 15 months after discharge. [28][29][30] Fourth, this study is a pilot with a small sample size. Generally, the required sample size is inversely proportional to the effect size. 31 If the effect size of CBT for alcohol is small, a larger sample size is necessary to detect a treatment effect.
Fifth, we did not collect data on medication or follow-up interventions, which are important variables that could influence outcomes. Since participants were randomized, these variables should theoretically be equal between the groups. However, we could not confirm if there was actually no between group difference.

| CON CLUS IONS
A relapse prevention program did not show any better outcome than psychoeducation in our 12-week inpatient program for alcohol dependence, although patients in both arms had significantly improved psychological outcomes. This study is the first randomized controlled trail on a pilot basis to evaluate the effectiveness of RP for alcoholic patients in Japan. Future research is expected to determine the effectiveness of RP for treatment of alcoholism in Japan with a larger sample size and a longer follow-up period.

ACK N OWLED G M ENT
The authors thank all staff members who helped to edit the workbook of the treatment program and served as a facilitator in conducting it.

CO N FLI C T O F I NTE R E S T
The authors declare that they have no competing interests.

AUTH O R CO NTR I B UTI O N S
TH and YA conceived of, designed, and performed the study. TH and YA supervised the treatment program and the outcome measurements. TH and YA drafted the manuscript and equally contributed for the study. MT, YY, and MU conducted the treatment programs and followed up the participants. YH performed the data management and statistical analysis. SO carried out the random assignment of the participants. NA participated in the design and coordination of the study, supervised the data analysis, and helped to draft the manuscript.

A PPROVA L O F TH E R E S E A RCH PROTO CO L BY A N I N S TITUTI O N A L R E V I E W B OA R D
This study was approved by the Institutional Review Boards of the

Tokyo Metropolitan Matsuzawa Hospital and the Tokyo Metropolitan
Institute of Medical Science (approval number H23-03).

I N FO R M E D CO N S E NT
All study participants provided informed consent.

DATA AVA I L A B I L I T Y S TAT E M E N T
The data that support the findings of this study are openly available in "figshare" at https://doi.org/10.6084/m9.figsh are.19314 077.v1.