Prolonged grief disorder (PGD) is included as a new diagnosis in international classification systems. Treatments following a cognitive behavioral model are most effective, but comparisons with active control treatments are scarce. To examine whether integrative cognitive behavioral therapy for prolonged grief (PG-CBT) is superior to present-centered therapy (PCT). This was a rater-blinded, multicenter, randomized clinical trial (stratified by center and relationship to the deceased) with enrollment from April 2017 to May 2022. The setting included 4 university outpatient clinics in Germany. Eligible participants were aged 18 to 75 years and had PGD based on the Prolonged Grief Disorder 13 (PG-13) interview. Participants were randomized 1:1 to PG-CBT and PCT. PG-CBT focused on the exposure to the worst moment of the loss and cognitive restructuring of grief-related cognitions in combination with solution-focused and experiential methods (eg, walk to the grave exercise). PCT was adapted in session length and number to PG-CBT and focused on a supportive relationship and coping with daily problems that may have arisen from the loss or grief symptoms. All outcomes were assessed at baseline, after treatment, and 12 months after randomization at follow-up. The primary outcome was a blinded assessment of the PG-13 severity score at follow-up. Secondary outcomes were self-reported depressive, somatic, and overall psychopathological symptoms. Of 544 treatment-seeking individuals experiencing bereavement, 212 eligible participants (mean [SD] age, 51.8 [13.3] years; 173 female [82%]) with PGD based on the PG-13 interview were randomized to PG-CBT and PCT (n = 106 in each condition). In the intention-to-treat analysis, both treatments yielded high reductions in PGD severity at follow-up (PG-CBT: Cohen d = 1.64; 95% CI, 1.31-1.97; PCT: Cohen d = 1.38; 95% CI, 1.09-1.66). After treatment, participants receiving PG-CBT demonstrated significantly greater reductions in PGD severity than those receiving PCT (Cohen d = 0.31; 95% CI, 0.03-0.57). At follow-up, this effect was only visible on a trend level (Cohen d = 0.28; 95% CI, -0.02 to 0.57), whereas participants in the PG-CBT group had significantly less depressive and general psychopathological symptoms. Twenty-three participants (20%) discontinued PG-CBT treatment, and 17 participants (16%) discontinued PCT. This randomized clinical trial demonstrates that PG-CBT was superior to PCT after treatment and at follow-up with regard to comorbid symptoms. Both treatments were shown to be effective and acceptable, showing the potential for dissemination and increasing patient choice. German Clinical Trials Register (DRKS) identifier: DRKS00012317.
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