Cognitive behavioral therapy and mindfulness-based cognitive therapy for depressive symptoms in patients with diabetes: design of a randomized controlled trial

BMC Psychology

Table 1 Instruments to assess primary outcome, secondary outcomes, moderators, mediators, and common factors

Concept	Measurement (items)**	Measurement in time points*
Concept	Measurement (items)**	T1	T2	T3	T4	T5	T6	T7
*Primary outcome measure*
Depressive symptoms	BDI-II (21)	x		x	x	x	x	x
	HAMD-7 (7)	x				x
*Secondary outcome measures*
Generalized anxiety	GAD-7 (7)	x				x	x	x
Well-being	WHO-5 (5)	x				x	x	x
Diabetes-related distress	PAID (20)	x				x	x	x
Intersession changes in mood***	Emotion Thermometers (5)
Glycemic control (from patients’ records)	HbA1c	x				x
*Moderators*
Psychological moderators
Neuroticism	NEO-FFI (12)	x
Attachment style	ECR-S (12)	x				x
History of depression	SCID	x
Demographic characteristics	-	x
Biological moderators
Diabetes specific characteristics (from patients’ records)	-	x
Degradation of tryptophan	trp/kyn	x
*Mediators*
Cognitive coping
Positive re-interpretation and positive refocusing	CERQ (8)	x			x	x	x	x
Reappraisal and distraction	TCQ (12)	x			x	x	x	x
Behavioral activation
Behavioral activation	BADS (7)	x			x	x	x	x
Rumination
Rumination	RRQ (12)	x			x	x	x	x
Mindfulness
Non-judgmental attitude and act with awareness	FFMQ (16)	x			x	x	x	x
Attention control	Self-Regulation Scale (10)	x			x	x	x	x
Self-compassion
Self-kindness, self-judgment, and overidentification	SCS (13)	x			x	x	x	x
*Common factors*
Therapeutic alliance	WAI-12 (12) & 18-item Rapport Quest. (18)			x	x
Patient expectancy	- (3)		x

* T1 baseline; T2 after first session; T3 after second session; T4 after fourth session; T5 after eighth session (post-treatment); T6 three months after training; T7 nine months after training.
** BDI-II - Beck Depression Inventory-II; HAMD-7 - Hamilton Depression Rating Scale; Emotion Thermometers; GAD-7 - Generalized Anxiety Disorder Scale; WHO-5 Well-being Index; PAID - The Problem Areas in Diabetes scale; NEO-FFI - NEO- Five Factor Inventory; ECR-S - The experiences in close relationship scale short form; SCID - Structured Clinical Interview for DSM-IV; CERQ - Cognitive Emotion Regulation Questionnaire; TCQ - Thought Control Questionnaire; BADS -Behavioral Activation for Depression Scale; RRQ - Rumination-Reflection Questionnaire; FFMQ - Five Facet Mindfulness Questionnaire; Self-Regulation Scale; SCS - Self Compassion Scale; WAI-12 - Working Alliance Inventory; 18-item Rapport Questionnaire.
*** assessed at the start of every treatment session.
Note: this table does not cover measures of treatment integrity.