PAPER II: Evaluating the effectiveness and efficacy of an Internet-based self- self-help intervention for the prevention of depression: A randomised controlled

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3.2 PAPER II: Evaluating the effectiveness and efficacy of an Internet-based self-help intervention for the prevention of depression: A randomised controlled trial.

3.2.1 Aims

This study (Lintvedt et al., 2011; see Appendix A2) aimed to explore whether an unguided Internet-based self-help intervention could reduce symptoms of

depression in a university student population with elevated levels of psychological distress (quasi ‘indicated’ prevention trial). Since the study was undertaken without any therapist support of the intervention or control groups, our specific intention was to estimate the usage and effectiveness of such sites by this age group in a real life setting. In addition, we undertook a CACE analysis for treatment effect to explore the potential effects of the intervention for those who received meaningful intervention services. A final objective was to evaluate user satisfaction with the online

intervention.

3.2.2 Method

Participants were recruited among university students. A total of 215 fulfilled the eligibility criteria: access to the Internet, a score of 20 or above on the Kessler Psychological Distress Scale (K10; Kessler et al., 2002) and signed consent. All eligible participants were posted a pre-intervention questionnaire, and the 163 participants (76%) who returned this questionnaire were enrolled and randomised to one of the conditions in the trial. A total of 60% of the participants in the recruitment sample reported that they had felt a need for help with a psychological problem during the last 12 months but did not seek help for their subjectively felt need for help, thus having an unmet need for help.

The Internet intervention condition comprised access to two online websites:

MoodGYM and BluePages. Participants in the control condition were informed when they received the pre-intervention questionnaire that the enrolment into the trial could last several weeks. The dropout from the trial was quite high with a mean dropout rate of 37.4%. Almost 47% of the participants in the Internet intervention condition and 28% in the control condition failed to complete the post-intervention questionnaire.

Unguided Internet-based self-help for symptoms of depression

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The MoodGYM tracking data showed that 20 participants (24.7%) in the

experimental condition, who did not return the post-intervention questionnaire, had used MoodGYM.

The K10 scale was used in the screening. The self-report 20-item Centre for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977) was used in the pre- and post-intervention test battery for assessing symptoms of depression. The

Automatic Thoughts Questionnaire (ATQ; Hollon & Kendall, 1980) measures the frequency of negative automatic thoughts associated with depression, was also used in the pre- and post-intervention test battery. Finally, Treatment Depression Literacy (TDL), measured medical literacy, psychological literacy, lifestyle literacy, and cognitive behaviour therapy literacy. Demographic variables in this study were age, gender, marital status, previous depression, help seeking and need for mental health service, reasons for not seeking help.

3.2.3 Results

Among the participants in the main study, 59% in the experimental condition and 62% in the control condition reported an unmet need for help. Of the participants who returned the post-intervention questionnaire, 67% in the experimental condition and 56% in the control condition had initially reported an unmet need for help.

Compared with those who dropped out, completers with an unmet need for help were more likely to report “Support from friends” and less likely to report the “Problem not serious enough” as reasons for not seeking help in the past. Participants in the Internet intervention group who dropped out had significantly higher pre-intervention CBT literacy scores than those who did not. Control group participants who dropped out had a significantly higher use of “Problem not serious enough” as a reason for avoiding help seeking than those who did not. A total of 62% of the participants remained in the trial at post-intervention including 52% of the Internet intervention participants. With respect to adherence, 27% of the intervention participants

completed on average 55% of MoodGYM without any support or reminders. There was evidence of intervention effectiveness as assessed using Intention-to-Treat (ITT) analysis. The between group effect sizes were moderately high, being d = .57 for depression, d = .50 for automatic negative thoughts and d = .56 for literacy. The intervention efficacy for compliers (pure treatment effect) was assessed by using the

Unguided Internet-based self-help for symptoms of depression

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Complier Average Causal Effect (CACE) estimate. Between groups effect sizes were d = .74 for CES-D and d = .54 for ATQ, and d = .68 for TDL. User satisfaction was high, with 83% finding the web sites useful or very useful.

3.2.4 Discussion

The results show that the Internet-based intervention, the combined use of the Norwegian versions of BluePages and MoodGYM, was effective in reducing

symptoms of depression (CES-D) and negative automatic thoughts (ATQ) in a university student population. The intervention was also effective in increasing depression literacy. A total of 62% of the participants remained in the trial at post-intervention with higher dropout among the Internet post-intervention participants. With respect to adherence, the Internet intervention participants completed on average three of the five modules of MoodGYM without any support or reminders. More than half of the Internet intervention participants, who failed to complete the post-intervention questionnaire, had used MoodGYM (on average 2.4 modules). A total of 67% of the completers initially reported an unmet need for help with a psychological problem.

Finally, participants were predominantly positive about the intervention.

The finding that the combination of BluePages and MoodGYM proved effective in reducing symptoms of depression and negative automatic thoughts, supports the results from the Australian studies on the effectiveness of these interventions (e.g., Calear et al., 2009; Christensen et al., 2004). The present study demonstrates the potential for Internet intervention programmes to reduce symptoms of depression with an unguided delivery method. The fact that the CES-D effect size for both completers and ITT was medium provides evidence of the effectiveness of the intervention effect regardless of compliance. The considerably higher CACE effect size shows the potential efficacy for this Internet based intervention. This is even clearer for the sub-groups, where the subclinical group and the mild/moderate group have high effect sizes. The increase in depression scores in the control group was unexpected, although this has been reported in one other study (Titov, Andrews, Choi, Schwencke, & Mahoney, 2008). The study also demonstrated the feasibility and successful translation of an interactive evidence-based Internet intervention into a different language and represents the first study of the use of an unguided Internet CBT program in Norway. The present trial confirmed that an unguided

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based Internet intervention could be effective in young adults. In addition, the findings demonstrate that the intervention has the potential to reach a target group with a perceived unmet need for help. The fact that two-thirds of the participants who completed the trial initially reported an unmet need for help with psychological problems indicates that the intervention motivated a self-help effort among a group of people who had not sought alternative or professional help.

Internet-based self-help could be a powerful tool for prevention and early treatment of depression, if it is made available and successfully promoted for those in need. Consequently, BluePages and MoodGYM should be further developed and implemented for large-scale early intervention and prevention of depression.

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3.3 PAPER III: Evaluating the translation process of an Internet-based self-help