Effectiveness of Disease-Specific Cognitive Behavioral Therapy on Anxiety, Depression, and Quality of Life in Youth With Inflammatory Bowel Disease

A Randomized Controlled Trial

Luuk Stapersma, MSC; Gertrude van den Brink, MD; Jan van der Ende, MSC; Eva M. Szigethy, MD, PHD; Ruud Beukers, MD, PHD; Thea A. Korpershoek, MANP; Sabine D. M. Theuns-Valks, MD; Manon H. J. Hillegers, MD, PHD; Johanna C. Escher, MD, PHD; Elisabeth M. W. J. Utens, PHD

Disclosures

J Pediatr Psychol. 2018;43(9):967-980. 

In This Article

Results

Demographic, Disease, and Intervention Characteristics

Figure 1 displays the patient flow throughout the study. In total, 70 patients were randomized (10–20 years, n = 50; 21–25 years, n = 20). In Table I, demographic and disease characteristics are displayed for both groups. No significant differences were found between the PASCET-PI group and the CAU group on demographics (e.g., gender and age) and disease characteristics (disease type, activity), nor as to whether patients were included based on anxiety, depression, or both. However, the median disease duration in years was higher in the PASCET-PI group than in the CAU group (2.59 vs. 1.17 years, p = .039).

Regarding treatment integrity, in the PASCET-PI group, 33 (89.2%) patients followed all 10 treatment sessions, one patient (2.7%) followed eight sessions, one patient (2.7%) followed five sessions, one patient (2.7%) followed three sessions, and one patient (2.7%) followed one session. The mean number of treatment sessions followed was 9.38. For the 21 patients whose parents participated as well, 76.2% of the parents followed all three family sessions. The mean number of family sessions was 2.57. In all sessions, at least 75%, and in 75% of the sessions, at least 80% of the required topics were discussed, indicating good adherence to the protocol (i.e., treatment integrity). A global estimation of interrater agreement, over all sessions and patients combined, was calculated. Treatment adherence ratings correlated .41 between the six raters (medium correlation according to Cohen, 1988). No patients in the control group sought mental health care and no study-related adverse events occurred during the trial.

Effect of Disease-specific CBT on Symptoms of Depression and Anxiety and HRQOL

As some cells in the cross-tabulation were smaller than five, a Fisher's exact test was performed. In the primary analysis, RCI values did not differ between the two groups for both anxiety (χ 2(2) = 1.656, p = .465, φ = .159) and depression (χ 2(2) = 1.648, p = .523, φ = .161; see Table II). Overall, patients in both groups either remained stable or improved in their symptoms of anxiety and depression.

In the exploratory analyses (see Table III), the same pattern was seen. No significant time–group interaction effect was found for anxiety [SCARED: n = 50, t(47.460) = −0.639, p = .526, d = −0.15; HADS-A: n = 20, t(16.047) = 0.976, p = .343, d = −0.06], depression [CDI: n = 35, t(32.004) = −1.272, p = .212, d = −0.11; BDI-II: n = 35, t(30.739) = −0.363, p = .719, d = −0.47], and HRQOL [IMPACT-III: n = 50, t(45.363) = 1.033, p = .315, d = 0.23; IBDQ: n = 20, t(18.124) = −0.539, p = .597, d = 0.44]. For the SCARED [t(48.059) = −5.709, p < .001], HADS-A [t(16.431) = −4.375, p < .001], BDI-II [t(31.236) = −4.778, p < .001], IMPACT-III [t(45.849) = 4.847, p < .001], and IBDQ [t(18.738) = 2.367, p < .05], the effect of time was significant, whereas for the CDI, this was not the case [t(32.525) = −1.554, p = .130]. These findings show that, after 3 months, all patients improved in their symptoms of anxiety and depression, as well as in their HRQOL. Even when these analyses were carried out only in patients who showed relatively "high" subclinical problems ("high" n = 40 vs. "low" n = 30), no group differences were found on the anxiety and depression outcomes (data not shown).

Influence of age, Gender, and Disease Type on Effect of Disease-specific CBT on Anxiety and Depression

In exploratory analyses for the four separate age-groups (classified by the four age-attuned questionnaires: SCARED [10–20 years], HADS [21–25 years], CDI [10–17 years], BDI-II [18–25 years]), no differences were found between the groups as to the change in anxiety, depression, or HRQOL. As we did not find group differences in all four age-groups, an age effect seems absent. We explored the possible influence of gender and disease type on the effect of the PASCET-PI by conducting linear mixed model analyses separately in subgroups (male vs. female and CD vs. UC and IBD-U). Overall, none of the subgroup analyses showed a difference between two groups on anxiety, depression, or HRQOL, except for a significant lower score on the BDI-II in the CAU group (n = 6) than in the CBT group (n = 3) for the subgroup analysis in men (data not shown). Therefore, gender and disease type do not seem to influence the effect of CBT.

Social Validity

With respect to satisfaction, patients reported a mean of 7.82 (out of 10), whereas parents reported a mean of 7.50 (out of 10). Mean scores of patients and parents for usefulness were 6.82 and 6.06 (out of 10), respectively. Furthermore, patients reported a mean of 6.96 (out of 10) for recommending it to other patients, and parents reported a mean of 7.25 (out of 10). These results indicate that, in general, patients and their parents evaluated the PASCET-PI positively.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....